Clara MacKay
CEO, World Ovarian Cancer Coalition

We regularly update this news round-up with the latest regarding the pandemic and efforts to bring COVID-19 vaccines and treatments to the world's population. 

Johnson & Johnson has expanded its Phase IIa clinical trial of the single-shot vaccine to include children aged 12 to 17 years. The shot, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, is authorized for emergency use to prevent COVID-19 in adults. The study started in September 2020 and once the data from Phase IIa is reviewed, will be extended to a larger group of adolescents. Learn more

Pfizer is to seek emergency approval for its COVID-19 vaccine in younger people after a US study found the shot was “well-tolerated” in children aged 12 to 15. The trial recorded 18 cases of COVID among 1,129 people in the placebo group and zero cases among the 1,131 who received the vaccine. Pfizer, who developed the vaccine in partnership with BioNTech, has said it will submit the study data to the US Food and Drug Administration in the coming weeks. Read more 

Pfizer has begun a Phase I study of a new oral COVID-19 treatment. The study will look at the safety, tolerability and pharmacokinetics of the PF-07321332 drug. According to Pfizer Development and Medical Worldwide Research chief scientific officer and president Mikael Dolsten, the “potential oral therapy could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care.”  Learn more 

Hong Kong has paused the use of BioNTech COVID-19 vaccines due to concerns over packaging. Across the city, staff at inoculation centers turned away people waiting to take the shot. Hong Kong had started offering the BioNTech shot in March. Read more

Leaders in the European Union have stopped short of a ban on vaccine exports. On Thursday EU leaders backed the idea in principle for strengthening export controls, but in a statement after the summit, the importance of global supply chains for vaccinations was emphasized. Read more

Update on the Oxford/AstraZeneca vaccine: Safety experts from the WHO are meeting to review the Oxford/AstraZeneca vaccine after several European countries paused their rollouts after reports of blood clots. However, the UK medicines regulator and the WHO say that there is no evidence that the clots are linked to the vaccine. Leading EU countries such as Germany, France, Italy and Spain were among those who suspended the use of the vaccine. But other countries such as Austria, have paused the use of certain batches of the shot, while Belgium, Poland, the Czech Republic and Ukraine said they would continue to administer the vaccine. Read more

Seven European countries halt some or all of their Oxford/AstraZeneca COVID-19 vaccinations due to fear of blood clots. Austria initially clamped down on a single batch of the vaccine after a clotting issue in a recipient. Now, Denmark, Norway, Estonia, Latvia, Lithuania and Luxembourg have followed in Austria’s footsteps, by stopping using vaccines from the same batch. Meanwhile, multiple health authorities have said there is no evidence that the shot is connected to blood clots. It’s not the first time AstraZeneca has encountered vaccine problems in Europe – the pharmaceutical giant faced questions over its supply shortfall earlier this year and then several countries expressed doubts as to the vaccine’s efficacy in people over 65. Read more. 

The European Medicines Association (EMA) approved the emergency use of the single-dose Johnson & Johnson vaccine, making the shot the fourth authorized by the bloc. Vaccines from Pfizer/BioNTech, Moderna and AstraZeneca have also been conditionally approved. The EU has ordered 55 million doses of the vaccine, which are due to be delivered in the second quarter. According to EMA Committee for Medicinal Products for Human Use (CHMP) the vaccine is 67% effective two weeks after the single dose.  Learn more.

Trials are underway to test the Pfizer/BioNTech COVID-19 vaccine in pregnant women. The US study will cover around 4,000 women between 24 and 34 weeks of gestation and trials on children will take place later this year. Two doses will be administered 21 days apart and the study will evaluate the safety, tolerability and immunogenicity of the shot. The trial will also look at safety of infants of vaccinated women and the transfer of potentially protective antibodies to their infants. Read more.

The UK’s vaccination program is having a "spectacular" impact on preventing serious illness in adults, according to researchers. The first data on the country's vaccine rollout shows that within weeks one shot reduces the risk of hospitalization by at least 75% for the over 80s. The figures from Public Health England (PHE) and Public Health Scotland (PHS) were published on the same day the government in England laid out the roadmap for lifting restrictions. Read more.

Risk of illness from COVID-19 drops by 95.8% after the second dose of the Pfizer/BioNTech vaccine, according to Israel’s health ministry. The findings were based on data collected through February 13th from 1.7 million Israelis who received their second dose at least two weeks previously. The shot was also 98% effective in preventing fever or breathing problems, as well as 98.9% effective in preventing hospitalizations and death. The country’s ambitious vaccination drive makes it the world’s largest study of the vaccine. Learn more.

Staying with the Pfizer/BioNTech vaccine efficacy - a new study has revealed that the first dose of the shot is 85% effective against infection between two and four weeks after inoculation. The Lancet medical journal published the study from Israel’s largest hospital, which focused on more than 9,000 healthcare workers. Scientists at Sheba Medical Center in Tel Aviv, found that the vaccine was 47% effective between one and 14 days after vaccine, rising to 85% after 15 to 28 days. Read more.

Pfizer and BioNTech have dosed the first participants in a global COVID-19 vaccine trial in preventing the virus in healthy pregnant women. The Phase II/III study will analyze the safety, tolerability and immunogenicity of two doses of the vaccine or placebo given 21 days apart. The trial will enroll around 4,000 pregnant women who will receive the vaccine from 24 to 34 weeks of gestation. The women will be part of the study for about seven to ten months, depending on whether randomized to receive the vaccine or placebo. Learn more.

Oxford/AstraZeneca COVID-19 vaccine offers only minimal protection against the South Africa variant, study finds. Data from a small-scale study consisting of 2,000 volunteers showed that the vaccine had high efficacy against the original coronavirus strain in South Africa, but protection reduced when tested against the B.1.351 coronavirus variant. Read more.

The UK government signs partnership with vaccine manufacturer CureVac to jointly develop vaccines against COVID-19 variants. The tie-up will combine the UK’s experience in genomics and virus sequencing with CureVac’s resources and knowledge in mRNA vaccine development. The UK will fast-track clinical studies with the goal of gaining emergency or conditional marketing authorizations for the vaccines as soon as possible. Learn more.

El Lilly & Company’s combination antibody drug for COVID-19 granted Emergency Use Authorization (EUA) by the FDA. The combination treats mild to moderate COVID-19 in patients aged 12 years and above at a high risk for progressing to severe disease and/or hospitalization. Data from the BLAZE-1 trial showed that the combination therapy lowered the risk of hospitalizations and death by 70%. Read more.

Clinical trials to test combining the Sputnik V and Oxford/AstraZeneca vaccines set to start in Azerbaijan. The objective is to boost the efficacy of the British shot. Both of the vaccines require two doses, an initial shot and a booster. The trial is part of a wider program involving hundreds of people in different countries across the world. Learn more.


Vaccine supply concerns increase as EU threatens to limit exports. Delivering vaccines to hundreds of millions of people was always going to be logistically difficult. So news that the EU has had problems with distribution may not come as a surprise to some. The EU has warned producers that they must deliver agreed vaccine supplies - saying that the bloc could restrict exports of vaccines. Read more. 

US pharmaceutical company Merck has announced it will stop developing its COVID-19 vaccine due to weak immune responses from the shots. Merck has said it will now focus on two treatments it’s developing - an antiviral medicine against SARS-CoV0-2 and another aimed at helping hospitalized patients reduce the immune system’s over-response to the virus.
Read more. 

Moderna is developing a booster shot against the South Africa coronavirus variant. A study showed that the company’s existing mRNA COVID-19 vaccine provided protection against new strains from the UK and South Africa, but suggested reduced protection against the South Africa strain. Moderna is now working on a new booster shot that could be used in combination with any COVID-19 vaccine. Read more. 

Johnson & Johnson’s one-dose COVID-19 vaccine has demonstrated an efficacy of 66% in a Phase III trial. The vaccine, which was developed by J&J’s pharma division, Janssen, was also 57% effective against the South African strain. The ENSEMBLE trial analyzed the efficacy and safety of the vaccine for protection against moderate-to-severe cases of the virus. Read more.

UK clinical trials of a nasal spray starts. Developed by SaNOtize Research and Development Corp. based in Canada, scientists found nitric oxide to be highly effective in resisting viral infections. The spray is designed to kill the virus in the upper airways of the nose, stopping it from spreading to the lungs. Read more.

FDA issues emergency use authorization for first COVID-19 vaccine. The emergency use authorization allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the US. Read more.

Johnson & Johnson trims the size of its Phase III COVID-19 vaccine trial. The decrease from 60,000 to 40,000 participants is due to the surge of COVID-19 cases across the US. Read more.

Sanofi suffers major setback in development of a COVID-19 vaccine. The problem relates to inadequate results in older adults, which the company traced back to an inadequate formulation of the vaccine, Su-Peing Ng, global medical head for Sanofi Vaccines said in an interview. Read more.

Pfizer and BioNTech achieve first authorization in the world for a vaccine to combat COVID-19. UK Medicines & Healthcare Products Regulatory Agency (MHRA) has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. Read the news. 

EMA publishes safety monitoring plan and guidance on risk management for COVID-19 vaccines. The plan is to ensure that all new information collected post-marketing will be promptly reviewed and any emerging new information will be shared with the public in a timely manner. Read more.

Pfizer and BioNTech conclude Phase III study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. Read more.

Moderna COVID-19 vaccine candidate meets primary efficacy endpoint. The Phase III study of mRNA-1273 met the statistical criteria pre-specified in the study protocol, with a vaccine efficacy of 94.5%. Read more. 

FDA authorizes monoclonal antibody for treatment of COVID-19. The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. The EUA was issued to Eli Lilly. Read the details. 

Novavax COVID-19 vaccine granted fast track designation by FDA. Novavax announced that the FDA has granted Fast Track Designation for NVX-CoV2373, the company’s COVID-19 vaccine candidate. The company expects to begin its pivotal Phase III clinical trial in the United States and Mexico by the end of November. Read more.

EMA implements extra transparency measures for COVID-19 vaccines and therapeutics. The European Medicines Agency (EMA) has published clinical data in support of the authorization of Veklury (remdesivir) and information on COVID-19 treatments and vaccines that have received scientific advice or informal guidance from its pandemic task force. Read the article.

FDA approves first treatment for COVID-19. The US FDA approved antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years and older and weighing at least 40 kilograms for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Read the article.

Eli Lilly pauses trial of antibody drug over safety concern. The ACTIV-3 clinical trial is paused because of a safety concern. Read the article.

J&J pauses coronavirus vaccine trials due to unexplained illness. Johnson & Johnson said the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians. Read the article.

EMA starts second rolling review, this time for Pfizer COVID-19 vaccine. The European Medicines Agency's human medicines committee (CHMP) has started a "rolling review" of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer. Read the details.

FDA publishes vaccine rules. The FDA released new safety standard for COVID-19 vaccines, with guidance that vaccine makers should follow clinical trial participants for at least two months to rule out safety issues before seeking emergency use authorization for a vaccine. Read the article.

FDA reshuffles priorities to meet COVID-19 trial demand. The sudden influx of COVID-19 trials work at the FDA has required pulling resources from various departments at the agency to support the efforts. Read the article.

Eli Lilly rushes to FDA with its COVID-19 antibody for emergency green light, reveals new cocktail therapy data. Lilly submitted an initial request for emergency use authorization for its antibody treatment, specifically for higher-risk patients who have been recently diagnosed with mild to moderate COVID-19. Read the article.

GSK and Vir to expand COVID-19 antibody treatment study. GSK and Vir Biotechnology are set to globally expand the study of experimental antibody VIR-7831 for the early treatment of COVID-19 patients with a high risk of hospitalization to Phase III. Read the article.

How research nurses and midwives are supporting COVID-19 clinical trials in the UK. Clinical research nurses and midwives have been central to the rapid implementation of COVID-19 clinical trials. Read the article. 

EMA begins real-time review of AstraZeneca’s COVID-19 vaccine. The European Medicines Agency initiated the first "rolling review" of a COVID-19 vaccine developed by AstraZeneca and the University of Oxford. Read the article.

Pfizer follows Moderna in releasing COVID-19 vaccine study protocol. Protocols are typically kept under wraps until studies are complete, but Pfizer and Moderna have made their SARS-CoV-2 trial protocols public in a transparency push. Read the article.

First patient in OSCAR trial receives GSK’s otilimab in UK. The Manchester University NHS Foundation Trust in the UK has said that the first patient in the OSCAR clinical trial received GSK’s investigational drug otilimab to treat severe lung disease related to COVID-19. Read the article.

Johnson & Johnson’s single-dose COVID-19 vaccine generates strong immune response, early data shows. The company released positive interim results of its Phase I/IIa study. It has moved into a Phase III trial that will enroll up to 60,000 volunteers across three continents. Read the article.

Older people likely to be underrepresented in COVID-19 trials.  A study published in JAMA Internal Medicine concludes that despite the fact that people over 65 are disproportionately impacted by COVID-19, they are underrepresented in the clinical trials. Read the article.

Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance. Investigators should review and report AEs and SAEs, according to updated FDA guidance. Read the full article.

Pfizer and BioNTech propose expansion of pivotal COVID-19 vaccine trial. The companies have submitted an amended protocol to expand the enrollment of their Phase III pivotal COVID-19 vaccine trial to up to 44,000 participants. Read more.

UK’s MHRA allows restart of Oxford/AstraZeneca COVID-19 vaccine trials. The Medicines Health Regulatory Authority (MHRA) in the UK has said that the clinical trials of the Oxford/AstraZeneca COVID-19 vaccine candidate are safe to resume. The late-stage trials were paused after a participant in the UK study experienced an unexplained illness. Read the full article.

Biopharma leaders unite to stand with science. Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. Read the pledge. 

Sanofi and GSK move COVID-19 vaccine into human trials. Sanofi and GSK are launching a large Phase I/II clinical trial at 11 sites across the US, initially enrolling 400 people. This candidate is the first outside of China to use a vaccine approach for which there is already a licensed vaccine. Read the full article.

Sanofi says Kevzara drug fails as possible COVID-19 treatment. The international Phase III clinical trials of Kevzara didn't meet primary or secondary endpoints and as a result trials will be stopped. Read the full article.

Phase III clinical testing of AstraZeneca COVID-19 vaccine candidate begins. A multi-site, Phase III clinical trial for AZD1222 has begun. The trial will enroll 30,000 adult volunteers at 80 sites in the US. Read more.

Translate Bio, Sanofi COVID-19 vaccine proves promising in animal studies. Experimental COVID-19 vaccine induced immune responses in animal studies. The companies plan to start human trials in November. Read the full article.

COVID-19 and readjusting clinical trials. The disruptions from the pandemic are numerous, but there are some reasons to be optimistic about changes with clinical trials, according to the Lancet. Read the full article. 

COVID-19 clinical trials must append more diversity, researchers assert. Researchers raise concerns about the lack of diversity in COVID-19 clinical trials. Read the full article.

Disruptions to global oncology trials have fallen to a three-month low. Cancer trials disrupted by COVID-19 are resuming faster than other therapeutic areas. Read the full analysis. 

FDA Coronavirus Treatment Acceleration Program (CTAP) dashboard. This dashboard provides updates specifically on therapeutics (not vaccines or devices). View dashboard.

Many early COVID-19 studies have low-quality design, risk low-value evidence, research finds. The researchers estimated that only about 29% of studies would produce data strong enough to potentially inform changes in clinical care. Read the full article. 

US biotech uses AI to pick antiviral for COVID-19 trial. US biotech AI Therapeutics begins a Phase II trial of its LAM-002A, an antiviral drug. The company develops drugs identified with a proprietary artificial intelligence (AI) algorithm. Read the full article.

"Promising" data on Oxford/AZ coronavirus vaccines. Data from more than 1,000 healthy volunteers dosed with a coronavirus vaccine developed at Oxford University and AstraZeneca suggest the shot is safe and stimulates an immune response against the virus. Read the full article. 

Moderna COVID-19 vaccine candidate has positive results in all participants in Phase I trial.  Moderna published interim analysis of the open-label Phase 1 study of mRNA-1273 in the New England Journal of Medicine. A Phase III trial is expected to start later in July. Read the report.

NIH launches trials network for COVID-19 vaccines and therapies. The COVID-19 Prevention Trials Network (COVPN) is expected to operate more than 100 trial sites across the US and internationally. The first Phase III trial conducted  is expected to be Moderna’s mRNA-1273 vaccine. Read the full article.

UK universities launch new COVID-19 drug testing platform. The University of Liverpool School of Tropical Medicine and Southampton Clinical Trials Unit launched a COVID-19 drug testing platform called AGILE. It will test multiple potential therapeutics. Read the full article. 

UK trial begins testing second-wave COVID-19 drug from US biotech Ridgeback. Ridgeback Biotherapeutics is starting enrollment for a Phase II trial for its oral antiviral drug EIDD-2801, which will be conducted using  the AGILE testing platform. Read the full article. 

Running clinical trials for other drugs in the age of COVID-19. There is some evidence of recovery for clinical trials beyond COVID-19. Read the full article.

Some COVID-19 trial sponsors never posted other study results in an EU database. Will they hide data again? Two-thirds of 118 COVID-19 clinical trials analyzed by the non-profit research advocacy group TranspariMED had no record of uploaded results to the European Union Drug Regulating Authorities Clinical Trials Database, though it is required under EU rules. Read the full article.

MHRA instructs all UK hydroxychloroquine COVID-19 clinical trials to suspend recruitment. UK clinical trials using hydroxychloroquine to treat or prevent COVID-19 should stop recruiting further participants, Medicines and Healthcare products Regulatory Agency (MHRA). Read the full article.

COVID-19 vaccine development pipeline gears up. There are 10 COVID-19 vaccines in clinical trials. They are working at a rate that could defy usual timetables, which on average is 10 years to develop a new vaccine. Read the full article.

FDA’s MyStudies app provides platform for electronic informed consent. The U.S. Food and Drug Administration is making its FDA MyStudies app available to investigators for free to obtain informed consent from patients when face-to-face contact is not possible or practical due to COVID-19.  Read the full article.

How COVID-19 could improve clinical trial conduct. Sheuli Porkess Director, Research, Medical and Innovation from the Association of the British Pharmaceutical Industry talks about three areas for change with clinical trials. Read the full article.  

The COVID-19 pandemic and clinical trial disruptions. Nearly 70% of global clinical trials have been disrupted by enrollment suspensions, according to research. Read the full article. 

FDA updates COVID-19 clinical trials guidance to address serious adverse events. The FDA updated guidance for clinical trial conduct, including how and when serious adverse events should be reported. Read the full article.

Institute for Advanced Clinical Trials for Children launches program to speed up COVID-19 pediatric trials. The Institute for Advanced Clinical Trials for Children (I-ACT for Children) launched the COVID-19 Emergency Access Program to speed up the development of pediatric COVID-19 trials. Read the full article.

Clinical trials press on for conditions other than COVID-19. Will the pandemic’s effects sneak into their data? Researchers will need to adjust their studies during the pandemic. Disruptions to movement and visit schedules and/or sickness or death caused by COVID-19 could impact the data of ongoing clinical trials.  Read the full article.

This Teckro news digest includes updates on COVID-19 clinical research and also impacts of the pandemic other ongoing clinical trials.

This World Health Day, the call is for a “fairer, healthier world.” We couldn’t agree more.

The idea implies a comparison to how things are and sets the scene for us to imagine how things could be. This reflection is fitting a year into the COVID-19 pandemic, which has shone a light on both societal inequities and gaps in health systems.

While at first glance simplistic, the notions of fair and healthy are actually quite complex. Both deserve a brief interpretation.

In our view, a fairer world would mean that all people have access to what we consider the basics of humanity – clean water, adequate food supply, a safe place to lay their heads at night, and access to healthcare. Going a step further, there are the socioeconomic factors that make our first statement possible. First, it is fair pay for a fair day’s work regardless of gender, ethnicity or any other factors. It also means fair access to education and training so those who want to work have employable skills.

A healthier world must include not only access to healthcare and treatments to cure illnesses, but it should also consider the roots of good health. Mind, body and spirit are all interconnected. Fortunately, the stigma associated with mental health is lifting and support for mental illness is more in mainstream conversations, which will open the door to help for those who need it. The pandemic has caused many to have feelings of isolation, anxiety and depression – which must be addressed just as those with physical illness from the virus.

Preventative care is also important for a healthier world. While health systems and governments can provide the support and care when we are sick, as global citizens each of us also has the responsibility to look after our own and each other’s health. Quality food with nutritional value and physical exercise are two keys to good health. While some of us are born with conditions that lead to poor health, many of us are literally sitting ourselves to ill health. This is especially relevant due to the pandemic as much of the world’s workers transitioned to work from home over a year ago now.

Against a backdrop of all of the components of a fairer, healthier world, clinical research has an important role to play. Modern science holds promise for many diseases, including rare diseases. And the more research, the more we learn, the more we come closer to beating diseases, including cancer. Just as important as the treatments or drugs that might battle illness, it is also crucial that we understand the importance of recognizing early signs and of early diagnosis.

On this World Health Day, we would also like to take the opportunity to highlight the importance of challenging the status quo when it comes to clinical trials. We saw the pharmaceutical industry move faster than ever before to develop treatments and vaccinations for COVID-19, and we hope that the industry continues at this pace for other diseases.

Over the past year, we have consistently promoted topics linked to a fairer healthier world. These include:

More diversity in clinical trial participants

Modernization of clinical trial operations

Just as fairer and healthier go hand-in-hand, we believe that accessibility and diversity are two sides of the same coin. Clinical trials must reach the hard-to-reach, which will lead to a greater diversity of gender and ethnicity in participants. It will also lead to better care for those in underprivileged communities or from less influential socioeconomic circumstances.

Yet for clinical trials to operate beyond major metropolitan areas and outside of major research institutions, the way they are run needs to adapt to the 21st Century. Here, modernization is an important element to increase the speed and efficiency of clinical trials while still preserving participant safety and data integrity. On-demand access to the protocol and real-time guidance for research staff to study experts are just two areas where we see trials can be dramatically improved. Now is the time to apply a true risk-based approach with better insights into trial challenges and early signals into potential safety issues. All of this is enabled with a digital approach.

Health is precious. On this World Health Day, we salute all efforts to raise awareness for the interconnectedness of the many aspects that contribute to good health. And while there has been much suffering and loss from COVID-19, may it also serve as a catalyst for permanent changes that will lead to a fairer, healthier world.

We’ve written a lot on these topics over the past year. Here are a few pieces with our points of view, along with a guest blog from Clara MacKay CEO, World Ovarian Cancer Coalition:

World Cancer Day 2021: There’s No Going Back

Rallying the Global Community to Tackle Inadequacies for Women with Ovarian Cancer   

Diversity in Clinical Trials: How Sponsors Can Help Close the Gap

You can learn more about this year's World Health Day campaign by visiting the official WHO website.

Teckro’s view on the important role clinical research plays in creating a fairer, healthier future for all.

World Health Day 2021: A Fairer, Healthier World | Teckro

Teckro’s View: World Health Day and a Fairer, Healthier World

I think we can all agree that most problems in life can be solved - or at least improved, through better communication.  

Clinical trials are no different. Yet technology adoption by sponsors and CROs has been slow, making clinical trial conduct curiously old-fashioned.  

Then, COVID-19 hit and changed everything. Both sponsors and CROs had to rapidly adapt to run trials safely remotely. Now we see that communication by and with study teams, site personnel and patients is essential. With the right communication on a steady basis, we see that engagement with the trials by both research staff and participants increases.  

Let’s look more at this idea of unlocking site engagement.  

Site engagement is at the heart of everything that counts when it comes to clinical trials. Engagement comes from meaningful and regular conversations between teams, and effective relationships and high morale are crucial for clinical trial success.  

The engagement of site staff is especially important when running multi-site trials where performance and operations across sites can vary. This can impact patient retention, compliance and even trial endpoints. Overall, the benefits of high-level site engagement have positive knock-on effects on every stage of the clinical trial process and cannot be emphasized enough. 

Let’s have a further look at why improved site engagement is important for clinical trials: 

Staff are equipped with the information and tools necessary to make their jobs easier so they can spend more time on what really matters – the patients. 

Strong site engagement keeps sites invested in trial success as they build better relationships and collaboration to improve performance. 

If a risk arises, staff can get the crucial information they need more quickly.  

Improved morale. Utilizing the right tools and technology can help to make site staff jobs easier to carry out and boosts overall satisfaction. 

Some quick points about what effective site engagement is not: 

It is not about to-ing and fro-ing via time-consuming emails or “Game of Telephone” when asking questions or seeking information during trials. Staff could be perceived as “engaged” as they try to find answers, but they can be frustrated by outdated and inefficient means of communication. 

Site engagement is not about newsletters or other generic email communications that take a top-down, one-direction approach to communication. Communication that is too broad runs the risk of being useful to no one.  

Site engagement is not about a one-size-fits-all approach.  

How Teckro’s Digital Platform Helps with Site Engagement 

Effective engagement starts with awareness of the needs and challenges of the different research staff roles. For example, a principal investigator and a study monitor both have time pressures. The investigator has just a few minutes to consider several protocols to identify the best clinical trial for a given diagnosis.  A clinical research associate (CRA), on the other hand, has time pressures in that she or he is responsible for several studies and needs to know the latest data, how all of the studies are progressing, and any relevant changes that require action. Both groups need access to the information they require, and to communicate with the right people without friction. 

This is where the Teckro Digital Engagement Platform can boost site engagement. Here are just a few examples:

Real-time visibility for proactive action  

It can be difficult for study teams when they don’t have an overview of what’s happening across sites. With Teckro, we have built-in analytics that provides insights so study teams can gauge engagement with their study and also assess potential risks. For example, we have seen that a high rate of interaction with Teckro Search at the enrollment phase is a good measure of whether a given site is on track to meet recruitment targets.   

Additionally, Teckro provides insights into communication effectiveness. It’s not enough to just send target messages - study teams want to know that the message is actually being consumed. Here the Teckro platform provides visibility into message open rates. Everyone on the study team has central access to the same dashboard so that there is a trackable chain of communication across study team members. This built-in visibility means Teckro’s platform provides the crucial insight necessary to measure effectiveness and understand site engagement. 

Immediate access to experts with Teckro Connect 

During clinical trials, urgent questions need answering without delay. The problem is that email and/or telephone take time. Teckro Connect creates a virtual, dedicated group with site staff and study experts so that research personnel immediately start conversations. This feature can speed time to resolution because the first member who sees the message can jump in and answer. The time zone is no longer an issue because there’s a team of experts on-hand rather than just one, and no go-between is required to pass the message on. 

Accessing the protocol quickly and easily is important for site staff to do their jobs effectively and efficiently. But for so long it has been difficult for them to access up-to-date versions of the protocol because they have been stored in files on dusty old shelves or slow desktop computers. Teckro Search means that at the touch of a button, site staff can get answers to the information they’re looking for, instantly. This may sound pretty straightforward considering the technological advancements over the last couple of decades. But clinical trials have been slow on the uptake so to be able to access the protocol so efficiently via smartphone or other digital devices is a game changer for site engagement. 

Timely relevant guidance and updates with Teckro Engage 

Research staff and monitors can use Teckro Engage for relevant timely guidance and updates. They can tailor messages with granular segmentation, targeting individual roles, countries, sites or even specific individuals. This is effective when it comes to site engagement as busy staff have a single system through which to find all communication rather than using outdated methods of communication. Furthermore, push notifications to smartphones draws attention to these messages, helping increase the chance of reading them because the messages are consolidated in one place. 

For the younger generations, technology is a natural part of how they live their lives. So it seems strange that they’re required to access the protocol via a portal or an email and use a go-between to have an urgent question answered by an expert.  

Rapid access to study-related information by site staff, CRAs and study experts at the touch of a button; is not a luxury, but essential. I’m optimistic that the fast-paced uptake of technology will continue, resulting in high-level site engagement and better trial outcomes. But at the same time, we should not take our eye off the ball because as the saying goes, old habits die hard!

Andrea Parish looks at how boosting site engagement with the help of Teckro's Digital Engagement Platform leads to better clinical trial outcomes.

Unlocking Site Engagement for More Efficient Trials | Teckro

How Teckro Unlocks Site Engagement for More Efficient Clinical Trials 

⚠️ Spoiler Alert: Neither COVID-19 nor coronavirus are on the list of "Cs"

It’s been a year since we were all dropped into a sci-fi story called the global pandemic. Yes, it was last year on March 11 that the World Health Organization declared the COVID-19 outbreak a pandemic. But unlike a fictional film script, we didn’t have time to prepare for the role nor could we flip to the end to decide whether we wanted to be part of this story.

Living under restrictive conditions for a year now, there are billions of us disrupted by COVID-19. It is quite humbling to think about the sheer scope of the pandemic and how it has affected us all as humans. The cost to human life is massive when we think about those who have been ill, the people who have died or lost loved ones, and also those suffering prolonged sickness from what is now known as "long COVID" with symptoms lasting weeks or months. The consequences of the pandemic touch all aspects of our lives – as individuals, friends, part of family units, students, employees, colleagues, community members, and citizens.

I thought I would take a different approach on the anniversary of the global pandemic and reflect on three positive things that have surfaced over the past year that I’d like to see here to stay. I’ve categorized them into three Cs: collaboration, communication and caring.

Vaccination programs are underway around the world. For example, in the US, the Centers for Disease Control and Prevention tracker shows more than 18% of the population has received at least one dose. In comparison, the UK is one of the countries farthest ahead with its vaccination program and has already reached more than 33% of the population with at least one vaccine dose.

It is remarkable to think that a year ago, there was no vaccine. And last March, it was unclear how quickly there could be a vaccine. If we looked at history, it took four years to get a mumps vaccination in the 1960s, but that was also based on groundwork started in World War II.

The world being in some kind of lockdown for four years was absolutely unthinkable. And so began a massive, global effort to search for solutions to our COVID-19 problem, ranging from vaccines to prevent us from getting sick to treatments that reduce the severity for those who do. United by a common problem, interesting collaborations blossomed. Pfizer and BioNTech announced their partnership in March 2020 and the goal to have a vaccine in clinical testing just a few short weeks later.

We also saw other collaborations between pharma companies, health authorities, government agencies and academic research facilities. A case in point is the AstraZeneca and the University of Oxford alliance announced in April 2020. Both the Pfizer-BioNTech and AstraZeneca-Oxford relationships yielded positive results with emergency use approval for their vaccines in many countries.

But more than drug development, there is also the massive task of manufacturing and distributing the vaccines. Last month, for example Novartis signed an agreement to manufacture the Pfizer-BioNTech vaccine. As we think about getting vaccines to remote and underprivileged countries in the world, collaboration will be key to make sure that no one on the planet is left behind.

This also raises the point: what else could be possible if drug makers collaborated on other treatments? Nearly 40 years on, there is no vaccine for HIV for example. While competition is great to challenge the status quo and drive innovation, we have seen this past year that collaboration is equally as powerful when united for the common good.

One of the trends over the past year has been one of transparency. Pharma companies and health agencies knew they had a big job ahead of them to convince the public that any vaccine was safe. Public distrust of vaccine motivations and past horrors from clinical trials gone wrong fueled fear and uncertainty about drug makers’ efforts. Left unaddressed, they had the potential to completely undermine the research and development work being done.

It was quite remarkable in September to see a press release from nine pharma companies – CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi – issuing a statement called “Biopharma Leaders Stand with Science.” United together, they wanted to ensure the public that while they were moving with great speed, they were not compromising safety and quality standards.

“Guided by science” has been a key theme used by the industry as well as government and health authorities. The pharma industry alone can’t dispel public fears because they are also the beneficiary of the sales of vaccines and treatments. So this is where we saw the regulators step up to the challenge presented by COVID-19.

The European Medicines Agency (EMA) for example, announced in September that it would require the publication of clinical trial data for authorized treatments and vaccines. In November, the US FDA published an explanation about its approach to emergency use authorizations for COVID-19 treatments and vaccines. More recently, the EMA and Health Canada collaboratively published the full clinical data reviewed as part of their authorizations of the Moderna COVID-19 vaccine.

In times of uncertainty, communication is critical. The global pandemic stepped up transparency of decisions related to clinical trials and drug authorizations that haven’t necessarily always been consistently or clearly communicated for the layperson to understand. This is a big step in boosting the confidence of the public and hopefully, this transparency trend will continue for non-COVID-related authorizations in the future.

My last “C” speaks to wonderful aspects of human nature. Faced with danger, we want to protect those most in need. Over the last year, we’ve seen this unfold in many different ways. Lockdown was difficult for many millions of people, but it was for the greater good to suppress the spread of the virus. Wearing masks is awkward and getting vaccinated is not the best experience, but they protect others from the spread of the virus.

Much of what happened over the past year was people thinking about others. But the toll of the past year was more than just containment of the virus. There is economic devastation in many sectors, including hospitality, travel, retail, and restaurants. There is also the emotional and mental health crisis that arose from people feeling trapped, alone and unable to cope. There is also the ongoing concern about burnout from employees unable to shut off working from home.

There has been a great sense that we are a global community – that we are in this pandemic together. And random acts of kindness and little ways of showing that we care for one another, that is humanity at its best.

I dislike the phrase “the new normal” because to me it feels like we are on autopilot. It’s like we slip from one way of being into another, without really reflecting on how or why we are doing what we are doing. To me, in spite of physical and emotional suffering, I believe the pandemic one year on highlights what is possible when we work together and care about each other. 

The WHO declared the COVID-19 outbreak a pandemic on March 11, 2020. Reflecting a year later, there are three positive trends here to stay.

Global COVID-19 Pandemic One Year Later | Teckro

Global COVID-19 Pandemic One Year Later and "3Cs" Here to Stay 

Teckro is leading the way with our company-wide commitment to gender diversity.

Before putting pen to paper to write this article about International Women’s Day, I debated whether I should be writing it at all. Shouldn’t I ask one of the many talented women who work for Teckro to write it instead, I wondered.

But as CEO of Teckro, I felt it my duty to highlight some of the company’s achievements when it comes to employing and promoting women. After all, human nature being what it is, we tend to look to others to see what we should be doing. And companies are made up of humans who make important decisions every day. So, if I could inspire other leaders to commit to taking bold steps towards leveling the playing field in terms of gender diversity in their companies, I should write the article, I thought.

When you’re running a company, you want the best people on your team. Gender or any other discriminatory factors shouldn’t come into it. But we don’t live in an ideal world and it can be hard to overcome internal biases. 

I’d like to emphasize that Teckro doesn’t promote women just because they’re women. We promote people fairly regardless of their gender – and this is the point. When companies do leave their biases at the door and assess individuals on merit, more women will naturally rise to the top.

Let’s have a look at some figures that show how Teckro is leading the way in terms of male to female ratios both cross-company and on our leadership teams:

Senior Management Team: 56% female, 44% male

Management across the company (all levels): 50% female, 50% male

While women at Teckro can rely on being paid equally to men and receiving equal opportunities for employment and promotion, the reality is that for millions of women across the world this is not the case. According to the United Nations:

In all countries, women are paid less than men, with the gender pay gap estimated at 23%.

Women earn 77 cents for every dollar men earn for work of equal value and there is an even wider wage gap for women with children.

If the trend keeps going in this direction, it will take the next 257 years to close the global gender pay gap.

A couple of years ago, there were more men called David and Steve leading FTSE companies than women or ethnic minorities. But in February this year, a UK government review found that the number of women on the boards of top UK-listed companies has risen by 50% in five years - making all-men FTSE boards “extinct.” 

But despite these promising figures, the report showed that women are still underrepresented in the highest leadership positions. To me, this demonstrates that we need to have more conversations about how to address gender gaps. 

It’s also important to remember that women don’t suffer discrimination just in the workplace. As we’ve written about in our blog a year ago on this very day, women’s participation in clinical trials is too low, with the male to female ratio for many disease types still not matching the real-world gender split. And women are 50% more likely to be misdiagnosed after a heart attack because they can experience symptoms differently – and most people don’t know this.

Just as we at Teckro contribute to the conversations about advancing diversity in clinical trials, we also have a part to play in the broader business world. 

To that point, I’m pleased to introduce a new Teckro podcast series called Women in Leadership. Our team has taken the opportunity to interview a group of accomplished professional women to give them a platform to share their thoughts about how we can address diversity at the top levels, as well as positive stories about progress made to date. 

For example, we hear from Elisabeth Baugh, CEO of Ovarian Cancer Canada about the importance of mentors and on-the-job training for women throughout their careers.

Then there’s Sabrina Martucci Johnson, CEO of Daré Bioscience who shares her vision for a more equitable balance when it comes to leadership and other influential roles.

And pharmaceutical executive Dairine Dempsey, explains how women often start off well at entry and mid-levels, but too frequently encounter obstacles at the higher echelons of leadership.

International Women’s Day is not just a Women’s Issue

Diversity isn’t just a good thing because it’s “fair” to women and other underrepresented groups. Diversity is something that’s desirable because it creates a stronger organization for all stakeholders. It leads to more creativity and better outcomes for businesses.

Different groups think and perceive the world differently. Bringing these perspectives to the business world is crucial to grow and develop into better organizations – with improved decision-making, risk-taking, and work environments.

So this International Women’s Day, I encourage businesses everywhere to make gender diversity one of their priorities. Teckro has gone from strength to strength since our inception five years ago, and I believe that this is strongly linked to our commitment to hiring the most talented people for the job. After all, people are one of the most precious resources for any company.

Teckro CEO Gary Hughes on why leaving biases at the door and assessing individuals on merit creates a stronger organization for all stakeholders. 

International Women’s Day 2021: Make Gender Diversity a Priority

International Women’s Day is not just a Women’s Issue. It’s a Business Issue.

An individual disease or disorder is defined as "rare" when, at any point in time, it affects less than one person in 2,000 in the population in Europe or about one in 1,500 in the United States.

There are more than 6,000 recognized rare disorders; about 80% are of genetic origin. Prominent examples of these include cystic fibrosis, Duchenne muscular dystrophy (DMD), Phenylketonuria (PKU), Amyotrophic lateral sclerosis (ALS), and various retinal dystrophies. Many cancers are recognized as rare as well.

As paradoxical as it may seem, it can be claimed that “rare diseases are really common” because there are so many of them. Rare diseases currently affect 3.5-6% of the worldwide population, an estimated 30 million people in Europe and 300 million worldwide. This means that almost everyone knows somebody with a rare disease.

Much of the focus on rare diseases has arisen because, until recent decades, they tended to be neglected by developers of new medicines. In fact, that is why drugs developed for rare diseases have been termed "orphan drugs." In most countries, incentives are implemented by regulatory authorities to encourage the development of orphan drugs.

There are real challenges in developing orphan drugs. Prominent among these is that it is difficult to recruit sufficient participants with rare diseases to clinical trials. Thus, several approaches to trial design have been advanced to overcome this issue. Regulators have also evolved ways of applying risk-benefit assessment to orphan drug trials through approval of new drugs on a "conditional" basis, for instance by requiring ongoing detailed safety reporting where trials have clearly shown efficacy but have not generated much safety experience.

A major disincentive to developing orphan drugs is the restricted size of the potential market: "rare" implies few users. Legislation exists to provide financial incentives to overcome this to an extent, but ultimately the drug developer often has to attempt to recover their investment by charging high prices for their drug. This inevitably leads to protracted negotiation between the drug developer and the authorities that will have to reimburse the costs of prescription. The highest barrier to overcome in getting a new treatment to patients with a rare disease may be to convince whoever pays for the treatment that it is economically worthwhile. Part of the solution should be to move away from expensive, traditional, slow and labor-intensive ways of conducting trials, to embracing systems that maximize digitally facilitated acquisition of source data.

A Transformative Era for Treating Rare Diseases

In developing a new treatment for a rare disease, the role of patient advocacy organizations is crucial. They can participate positively by funding basic research in the disease and by focusing researchers to concentrate on getting promising treatment approaches from "bench to bedside" without delay. When treatments enter clinical trials, these organizations can identify likely trial sites and they can promote trial participation among their members. Ideally, they can contribute to trial design, especially by identifying meaningful endpoints. Patients' organizations, such as Eurordis in Europe and NORD in the US, fulfill outstanding roles in promoting and encouraging the development of orphan drugs, among many other advocacy activities.

When legislation was formulated decades ago to define "rare," the era of personalized medicine had not yet dawned. Since then, we have become aware that many common diseases are comprised of numerous distinct subtypes, often defined by molecular biomarkers. For example, breast cancer, ostensibly a common disease, is now seen to comprise five main molecular subtypes with differing clinical characteristics, prognoses and treatment approaches. Therefore, some distinctive subtypes of overall common diseases may be rare. These have benefited from the evolution of ideas about drug development in more classical rare diseases.

Although gene therapies have been attempted for some rare diseases since the mid-1990s, we are now at the start of a transformative era for treating rare diseases, particularly those of genetic origin. For example in 2012, Glybera, a gene replacement treatment for lipoprotein lipase deficiency, became the first such treatment to be approved for clinical use in Europe. And there has been a steady, if slow, stream of other new somatic cell gene replacement therapies. CAR-T cell therapies, using gene-replaced autologous T-cells, have been approved in the last couple of years to treat some rare cancers. Potentially most widely applicable, there is considerable hope for CRISPR/Cas9 gene-editing in the medium term to correct somatic genetic mutations that lead to disease.

A couple of decades ago, people with a rare disorder had to put up with a gloomy diagnosis and the knowledge that little could be done to treat them. The Orphan Drug Act of 1983 in the US, passed to facilitate and encourage drug development for rare diseases, transformed their outlook and introduced hope. It also kick-started the global biotech industry. Unfortunately, drug development is a slow process, and many people are still waiting for cures. However, rare diseases are at the forefront of drug developers’ minds. Major advances in molecular and cellular biology have brought us to a place where we can see routes to treat and cure many of these debilitating and life-threatening conditions. Still, there are issues to be resolved, in particular one of economics. 

A hallmark of a truly civilized society is that it regards the right to treatment as equal among citizens. Those with a rare disease should not be left behind.

Blog: We’ve entered a transformative era for rare disease, though there are still barriers in getting treatments to market. 

Transforming Rare Disease Treatment | Teckro

When most people think of clinical trials, they tend to imagine large pharmaceutical companies investing vast amounts of resources into developing life-saving drugs. 

Here at Teckro, we work with 10 of the world’s top 20 pharmaceutical companies supporting their clinical trials with our digital engagement platform. 

But this is not the full story when it comes to drug development and the role that biotechs play in delivering innovative treatments to the market. 

In my role at Teckro, I work closely with both large pharmaceutical companies and smaller biotechnology companies, helping them run their trials more efficiently and safely. Not surprisingly, biotechs face a mountain of challenges when it comes to running clinical trials just like the big pharma companies. 

Yet, unlike the industry giants, these biotechs don’t have the depth of people and financial resources nor the breadth in their drug development pipeline to sustain them if their research doesn’t yield successful results. Given the fairly low overall probability of success for drugs and vaccines, it is a fight for survival for smaller drug development companies. 

It can mean an uphill battle for biotechs, who are competing with large pharma for high-quality investigators and research sites. And everyone in the industry is competing to recruit a diverse participant population. This is especially difficult for some therapeutic areas such as oncology, where estimates suggest that fewer than 5% of cancer patients participate in clinical trials.  

Finding and retaining these people – from participants to investigators is no small challenge. I also would argue that it is a main reason why biotechs need to be nimbler and more innovative in how they approach their clinical trials than their larger rivals. 

From this author

Every clinical trial starts with a question