2020 was a difficult year - to put it mildly! If you had told me this time last year that our lives would be so thoroughly disrupted, with work, schools and social lives all moving online, I would have found it hard to believe. The novel coronavirus, COVID-19, has changed everything so dramatically and we have not yet come out of the other side of the chaos.
But despite the gloom, there is much to be hopeful for in 2021 and beyond. The world’s most talented scientists collaborated to develop vaccines at record speed. Science and technology have shown us what is truly possible. I am proud to be part of the clinical trials industry that has helped facilitate this incredible story of human ingenuity.
As a result of the disruption, the world is keenly focusing on clinical trials. Those working in the industry are not used to the limelight. They work hard quietly in the background to keep trials running so drugs can get to market and lives can be saved.
But in the last year, clinical trials have gone from being an abstract idea of how drugs are developed, to a key factor in how people can protect themselves, their families and get back to normal life.
And what we have seen has been extraordinary. The Pfizer-BioNTech vaccine, first fast-tracked for emergency use in the UK in early December and followed swiftly by the US and Europe, represents a breakthrough scientific achievement to fight this devastating pandemic. The Moderna vaccine, which uses the same mRNA technology as the Pfizer vaccine, has been approved in the US and the EU. As well as this, the Oxford-AstraZeneca vaccine is being rolled out in the UK as I speak, with the first person vaccinated in the first week of this year.
I am optimistic that the situation will look different by summer 2021 and that what we have learned as an industry from COVID-19 will have positive consequences for society.
In 2020 we have seen how successfully the human race can work effectively together to accomplish big goals for humanity. Goals that previously didn’t seem possible. From vaccine researchers, to the amazing medical staff on the ground, everyone has played their role. Here at Teckro we also did our bit supporting drug trials to help find treatments for COVID-19. And we will continue in our mission to help the world recover from this difficult period by supporting clinical trials success.
So, there is much to be thankful for and much to look forward to. Here are four reasons to be optimistic for the clinical trials industry in 2021 and beyond:
Initially, scientists were careful not to promise quick results when it came to developing a vaccine. There was much speculation around the idea of a vaccine being discovered so fast – in an industry where the process is complicated and safety is paramount.
Vaccines have eradicated many deadly illnesses throughout history, from mumps to smallpox and polio, and have greatly increased the average life expectancy. Prior to COVID-19, the fastest a vaccine had ever been developed from early sampling to approval was four years – the mumps vaccine in the early 1960s. In contrast, an AIDS vaccine is still not available after 30-plus years of effort.
Luckily, history was made. The world collectively breathed a sigh of relief. The news of the Pfizer-BioNTech vaccine was announced early November. The vaccine took just 10 months to follow the same steps that normally take 10 years.
But this achievement goes beyond COVID-19. The fact that a vaccine has been developed at record speed, bodes well for the future of vaccines, drugs and treatments. I predict we will see profound cultural and practical changes in the way companies approach the clinical trials process and what they deem possible. This has the potential to save many more lives across the globe.
When the pandemic hit, many clinical trials were forced to stop. Some trials were too complicated to continue without the physical presence of patients and staff such as oncology trials. But other trials were able to continue by adapting to new ways of working. Sponsors moved at hyper speed to make the most of solutions such as decentralized trials, wearable technologies and real-time communications technology.
The pharmaceutical industry has been slow to adapt to the modern age, but COVID-19 has sped the process up. This lag of uptake happened despite the modernization of ICH Good Clinical Practice (GCP), with the introduction of ICH E6 (R2) which required sponsors and CROs to implement a more robust risk management process.
The aim was to make sure clinical teams applied critical thinking lessons learned from previous trials. The technology was available to enable this approach, but full industry adoption was still too slow.
Now it seems that pharmaceutical and biotech companies have discovered what many other industries already knew - that there are huge advantages to utilizing technology – which can be used to optimize clinical trials, leading to greater safety, efficiency and data integrity. I am optimistic we will see companies continue to adopt new solutions at pace in 2021 and beyond – and it’s about time, too.
Statistics show that ethnic populations in the US made up of Blacks, Asians and Latinos, represented just a quarter of trial participants over 10 years. This urgently needs to change and technology can help by bringing communities closer together.
As discussed above, the rapid uptake of technology will lead to smoother relationships between stakeholders working in the clinical trials industry as communication and efficiency are improved. The same can happen in local communities. Strengthening connections between participants, community HCPs and research sites on the ground can improve diversity by building trust with underrepresented groups. And solutions such as decentralized trials can make it easier for them to access trials, as they won’t have to travel, or lose out on work.
Ironically, technology can help to “humanize” the clinical trials process, with stronger ties at a local level helping to bridge the gap between ethnic minorities and clinical trials.
COVID-19 has shown the necessity for data transparency when it comes to expediting the drug development process. Regulators need data to make informed decisions about which treatments and drugs they will approve and why. Decisions need to be made that are supported by the data, which should be available to healthcare professionals and the general public.
This may sound obvious, but access to the right information increases trust – which is crucial to ensure uptake of vaccines and treatments to fight the pandemic. Research in 2020 showed that sponsor organizations continue to miss reporting deadlines for publishing results within one year after a study has finished. This lack of openness must and will change.
After all, COVID-19 has changed the game, with the European Medicine Agency (EMA) deciding to publish clinical data for COVID-19 medicines, such as the authorization of Veklury (remdesivir). The EMA will also publish information on the COVID-19 treatments and vaccines that have received scientific advice or official guidance from its pandemic task force.
Data visibility needs to be built into the entire process of clinical trials, not just the reporting of completed trials. This is why we founded Teckro, clinical research should be simpler and easy to access. Today, data openness is no longer a nice-to-have, but a must-have and I predict that the pandemic will kickstart a new trend with greater data transparency. This means that the whole research community as well as the public can remain involved and informed when new drugs, treatments and vaccines are developed and approved.
Teckro came into existence in 2015. Five years connecting all clinical study stakeholders with the answers they need and of working hard together to achieve our goals. Like everyone else, we have had to adapt to new working practices this year to ensure we all remain safe and secure. It has been a huge learning curve for us, with our team emerging stronger than ever. For this, I am incredibly proud.
Our purpose to modernize clinical trials is now needed more than ever. The situation is urgent and while the industry has adapted successfully during the pandemic, the challenge is to continue this in the future. The good news is that we have seen the best of humanity working together to find a solution to the chaos unleashed on the world and the industry has made huge leaps forward.
The future is bright and moving into 2021 and beyond I am optimistic that the clinical trials industry will be transformed and fit for the modern era. Here at Teckro, our mission is to support clinical trials stakeholders across the board and to save more lives by speeding up drug development. I have faith we will succeed and am looking forward to the year ahead – it will be a good one!