New industry research, conducted by the Tufts Center for the Study of Drug Development (CSDD) in collaboration with Teckro, gathered responses from investigative site staff on how and when they interact with the clinical trial protocol.

This webinar features experts who present the current challenges with clinical trial diversity, and how we can make trials more accessible for both patients and physicians.

This solution overview illustrates how with Teckro sponsors can overcome COVID-19 disruptions for ongoing clinical trials and accelerate new infectious disease trials.

This resources center features eBooks, webinars, FAQs, best practices and other useful content for sponsors, monitors and research staff. 

Resources Center

It’s not a stretch to say that enrollment can make or break a clinical trial. Nearly half of all sites under enroll or fail to enroll a single participant, according to statistics from the Tufts Center for the Study of Drug Development. Without participants, trials are delayed. In some cases, eligibility criteria are amended. In more extreme cases, trials are cancelled because there aren’t enough people to participate.

For a Top 10 sponsor, the study team for a large respiratory clinical trial wanted to do as much as they could to help research staff quickly enroll participants. They decided to make the study protocol and related documents available via Teckro, forgoing paper shipments, PDFs in online portals, and manually-created FAQs. Site coordinators could optionally request a PDF of the protocol for their sites, but it was not encouraged by the study team. With Teckro Search, the current protocol – and therefore the current eligibility criteria – are always on hand from any digital device so that physicians can decide instantly whether the person in front of them is a candidate for the clinical trial.

3x More Participants Randomized by Sites Using Teckro

Enrollment figures confirm what the study team hoped would happen: When the study protocol is immediately on hand, it is easier to confirm eligibility criteria and therefore sites would enroll participants faster. This is exactly what happened. Leading up to the COVID-19 pandemic, the trial was ahead of its recruitment targets, which the study team attributes, at least in part, to making it easier for research staff to look up inclusion and exclusion criteria from a digital device when they are with a patient. The main interface to the protocol is Teckro, though site coordinators could request a PDF copy of the protocol for their sites. Still, the vast majority of sites use Teckro. The result is that sites that are active on Teckro randomized 3x more participants than those not using Teckro. In fact, sites not using Teckro at all only contributed 15% of the total number of participants randomized.

The fact that the protocol is only distributed via Teckro helped increase site adoption and usage. It also saved time and effort as no FAQs are manually maintained. More than 80% of all sites invited registered on the platform and 90% of CRAs are active. The feedback to the study team from both CRAs and site staff is overwhelmingly positive as they are happy to replace the habit of retrieving paper with their mobile phone. Not only does it save time, it also makes investigators, study coordinators and the CRAs more likely to look up information more often. This not only supports their decision making for enrollment, it also reduces errors.

Given the number of sites, the study team didn’t want to ship paper or update documents in a portal for each new version. Since the launch of the study, there have been four protocol amendments and two versions of the pharmacy manual. However, study information in Teckro is always the correct, current documents, so the study team doesn’t have to worry about version control. Looking at the usage patterns, it confirms that research staff want study information on the go as 75% of site staff access Teckro from a mobile device. And not surprising, eligibility and screening are among the Top 5 searches.

Immediate answers at the point of care allow research staff to make better decisions throughout the study. Better than any “cheat sheet” or quick reference guide, Teckro puts the protocol plus any other supporting study documents in the hands of research personnel on their smartphones. Working with study teams, we ensure that the right documents are available for the right sites to reduce the risk of anyone following the wrong version of the protocol. Real time answers are always available to enroll the right patients, properly carry out the procedures for a given visit, and correctly assess how to respond to adverse events.

Looking at search trends gives the sponsor insights into the types of questions sites have. Keywords being searched can highlight areas where sites may need more information. Equally, high-risk terms could provide an early view into potential safety issues. Based on the stage of the study, search terms will naturally shift from eligibility to visit assessments and safety, such as reporting requirements for adverse events and dose modifications. All of this provides a wealth of information for the sponsor to understand what research staff are facing and take proactive action.

Search activity also gives the sponsor visibility into which sites are engaged with the trial. Those sites with more search activity, particularly during the enrollment phase, are more likely to meet recruitment targets than those sites without any activity. In this case, there is a stark difference in screening results for sites using Teckro to confirm eligibility compared with those sites not using Teckro. With immediate access to the protocol from their mobile phone, answers to help with eligibility decisions are just a couple of taps away.

Download the full analysis of a Top 10 sponsor's experience with Teckro

Recruitment targets were exceeded by research sites using Teckro for a Phase III respiratory clinical trial from a Top 10 sponsor. 

Faster Trial Recruitment Case Study | Teckro

Case Study: How a Top 10 Sponsor Exceeded Recruitment Targets with Teckro

How a Top 10 Sponsor Exceeded Recruitment Targets with Teckro

No More Paper, No More Portals

The global pandemic created situations for which no one was prepared. With lockdowns, restricted movement, and healthcare professional preoccupied with treating COVID-19 patients, clinical trial operations were halted and enrollment paused.

Months later as lockdowns eased, there was then uncertainty on how to safely resume operations. A Top 30 global pharma decided to get direct site feedback on the situation using Teckro Survey. The results gave the study team insights into how sites viewed telemedicine and whether it could help to resume operations.

Nearly two years into the four-year study, COVID-19 presented an obstacle as research sites halted enrollment for this Phase III study. Months later, this Top 30 sponsor needed to validate whether telemedicine would be of interest to its sites and how feasible it would be to get the technology approved for use at the institutions.

More than half of sites reopened enrollment and more than 60% of respondents said their site had taken alternative action for follow up visits.

Furthermore, 69% said their institution offered a telemedicine and 57% of respondents said they weren’t interested if this sponsor offered a telemedicine option.

And even if home visits were approved, 79% said it would take more than four weeks to get approval.

In testing its theory, the study team concluded that telemedicine wasn’t something that would benefit its sites and it wouldn’t be useful to get the study back on track.

With advice from our team, the sponsor designed the survey to get a quick return.

The survey was simple. It included 10 questions with simply worded questions and short answers. All of the questions except for one  provided two choices, such as “yes” or “no” with the option for respondents to provide extra comments to  expand on their answers. The only question that didn’t follow this formula was one that provided four options  on how long it would take for a telemedicine system to be approved by the site.

Target list of respondents was carefully selected. The study team focused on those sites and users active on Teckro. They created three groups based on geography so as to analyze responses among the US, Europe and Asia Pacific. They also focused on key roles of site coordinators, principal and sub investigators, and extended site staff. Not surprising, site coordinators responded the most, representing 71% of the total.

The objective was clear. The purpose of the survey was clear and relevant to the target audience. The questions were easy to understand and the recipients would know the answers without much thought. It was also obvious to participants that the purpose was to test whether they could benefit from telemedicine as a method to get the study back on track.

CRAs were instrumental in reaching site staff; CRAs for all of the sites selected were notified via a Teckro alert about the survey so they could encourage their sites to participate. 

The initial survey was open for just one week, so the window to respond was quite short. With such a light touch, the study team was pleasantly surprised, particularly with a 31% response rate from the US team. 

The selection of sites and individuals based on their usage of Teckro could be one explanation for the strong response rate. These individuals were already regularly consulting Teckro for study answers, including eligibility criteria for enrollment and visit schedules. Therefore, it was logical that they should also provide feedback via Teckro.

To capture feedback, it needs to be simple, quick and easy for the user. And the request for feedback should come from a familiar source that is relevant to the user. In this case, Teckro Survey checked all of the boxes.

Users are directed to the online survey through alerts from Teckro. They complete the survey from any web-enabled device. Sponsors can view the responses through a Teckro dashboard or download as a spreadsheet for further analysis.

Built on the Teckro platform, sponsors can decide to add Teckro Survey to their study. A simple wizard interface walks them through the process of creating of a survey. For users, they simply receive alerts when surveys are sent to them, there is nothing extra that needs to be added or installed.

Download the full analysis of this Top 30 sponsor story.

Real-time site feedback was captured by a Top 30 sponsor using Teckro for this Phase III cardiovascular trial disrupted by COVID-19. Read case study. 

Real-time Site Feedback Case Study | Teckro 

Case Study: Real-Time Site Feedback Guides Sponsor Decisions

Could Telemedicine Help Sites Resume Trials Disrupted by COVID-19?

Real-Time Site Feedback Guides Sponsor Decisions

This year, we are celebrating our 5th anniversary. A lot has happened at Teckro and in the pharma industry over the last five years. 

We’ve grown with our early sponsors and added a lot more along the way. Our endgame is to support the industry in getting new drugs and treatments to market. Now, trials run on Teckro are reporting positive results. Some have also received regulatory approval. 

This infographic timeline represents Teckro milestones along with some key industry events over the past five years. 

This short video animates the Teckro milestones and key industry events over the past five years.

Video: Our Journey over 5 Years

This infographic is a snapshot of some notable milestones for Teckro and the pharma industry since our founding in 2015. 

Infographic: Our Journey over 5 Years

This year, we are celebrating our fifth anniversary. A lot has happened at Teckro and in the pharma industry over the last five years. 

This short video provides a timeline of Teckro milestones along with some key industry events over the past five years. 

This infographic represents our five year timeline as an alternative to the video.

This video captures our journey over the past 5 years, with highlights from Teckro along with pharma industry milestones.

Teckro was founded on a mission to simplify and modernize clinical trials. We are about making clinical trials simpler, more accessible and transparent. We believe that when immediate answers and essential guidance are accessible at the point of care, there is better protocol compliance, faster patient enrollment, and fewer errors. In the end, it reduces clinical trial costs and speeds time to market for life-saving treatments.  

 Watch this video for more about our corporate story. 

This is the Teckro corporate story video in less than two minutes

Video: Corporate Story | Clinical Trial Resources | Teckro

Video: Our Corporate Story

Video: Teckro Corporate Story

ACRP_Imact_Tech_Use_Report_080520.pdf

In January 2020, the Association of Clinical Research Professionals (ACRP) convened a Working Group of sponsors, CROs, technology companies, and site representatives to provide recommendations regarding the roles and competencies considering increased use of technology in clinical trials. Teckro was among the technology companies to participate.  

This white paper is the result of the Working Group recommendation as well as direct field feedback from a survey of clinical trial professionals who saw their jobs dramatically change as a result of COVID-19.  

The majority of decentralized clinical trials will be hybrid, at least in the short term.

Aspects of decentralization will be leveraged more often and accepted more by the industry due to COVID-19.

Increased use of technology will impact nearly every role, bringing new levels of flexibility and efficiency. 

Rather than threatening job roles, technology will require the need to evolve existing roles.

Technology training must be standard practice and written into each site manual and delegation log.

"Modifying methodologies and increasing the use of technology will ultimately improve clinical research. However, it will require patience and understanding to navigate our way through this transformational change."

ACRP provides a wealth of resources, including certifications and training courses as well as industry news, insights and also networking opportunities with industry peers. Visit the ACRP.org for more information. 

ACRP white paper from an industry working group including Teckro considers the impacts of greater technology usage on the clinical research workforce

ACRP White Paper: Technology and the Clinical Research Workforce

White Paper: The Impact of Increased Technology Use on the Clinical Research Workforce

An Assessment of the Adequacy of the Clinical Research Workforce

ACRP White Paper: The Impact of Increased Technology Use on the Clinical Research Workforce

With so many great questions during our webinar “No One Left Behind: Addressing Clinical Trial Access and Issues Blocking Physician Participation,” we prepared a FAQ that consolidates thoughts from our presenters. The webinar recording is available in our Resources Center. 

What are the barriers to clinical trial diversity from a site and patient perspective? 

There was updated research presented during the webinar that showed the lack of diversity for both participant subgroups and investigators. If, for example, sponsors and CROs rely on the same sites for each trial, this may limit the opportunity for newer investigators. But at the same time, physicians and institutions providing health care to minority populations tend to be overworked and under resourced. There is a practical question about their ability to participate in research. 

For the patient population, barriers can range from language, literacy, economic factors (such as having medical insurance) and adequate transportation to travel to medical facilities. Among underprivileged populations, there may simply be no awareness of clinical trials. Without a general understanding of drug development, the very people who could benefit from participating in clinical trials may not even know to ask the question “are there are clinical trials that may help with my symptoms?” On the other side, there is also mistrust among certain populations whereby participants will be distrustful or fearful of clinical research. 

How could COVID-19 impact diversity in clinical trials? 

COVID-19 has the potential to significantly alter clinical research. For one, clinical trials are now a global conversation, and the progress of COVID-19 trials is covered by mainstream media. People who wouldn’t have paid attention to clinical trials before are now aware of their purpose. This is a good thing in that it may result in more people asking whether there are clinical trials for their particular condition. At the same time, COVID-19 has exposed the disproportionate rate at which non-white people are more affected and are dying at a greater rate. Whether COVID-19 presents differently in ethnic populations or whether the populations most affected are living in conditions that heighten the chances for the virus to spread, much more analysis is needed. 

How do we go about making it mandatory for sponsors to have diverse representation in their clinical trials? And what is the role of government agencies, such as Department of Health and Human Services, National Institutes of Health (NIH), and the U.S. Food & Drug Administration (FDA)? 

Industry and government agencies need to work hand-in-hand to ensure that the participants of clinical trials align with the distribution of the population for the drug being tested. There needs to be a scientific justification for inclusion and diversity. The NIH, FDA and others have initiatives and programs to expand diversity, but more progress needs to be made. Greater transparency will create more incentives – the FDA is already moving in this direction with drug trial snapshot reports. However, there needs to be real incentives – or consequences – if trial populations aren’t representative. Grants and other funding sources could be linked to diversity requirements. It could be that the publication of a research study is contingent on the sponsor’s ability to demonstrate that it achieved a proportional representation of the population. There are steps that can be put in place that sponsor companies need to demonstrate in support of successful commercialization. 

Everyone now is talking about being a sponsor of choice. Do you see this as this legitimate or even realistic goal in the best interest of patients and sites? 

Yes, being a sponsor of choice means you are both ethical and caring. As a sponsor, you approach clinical research with more humility and prioritize patient safety. You have an open and helpful relationship with your sites, which includes adhering to agreed payment schedules. The outcome is more responsive, trust-based relationships. This approach is realistic and in the best interest of everyone involved in clinical research. There are sponsors already taking this approach, and we hope to see more. 

Do you have any thoughts on using heat maps in recruiting minority/diverse patients into clinical trials? Does a larger population equate to enrollment success? 

Approaches, such as heat maps, can be helpful in identifying communities where there is a big sub-group of patients that could be a recruitment target for a particular clinical trial. Logically, it stands to reason that targeting a larger population increases chances of meeting enrollment targets. But in reality, a larger population doesn’t necessarily translate into enrollment success. There are other considerations, such as the quality of the medical capabilities to serve a particular population, and also whether there are active investigators who can engage the community. Tools such as heat maps can help, but enrollment success will come down to the enthusiasm and capabilities of the investigators to drive interest and recruitment.

Can real world evidence play a role in increasing enrollment of a more diverse population?

Real world evidence (RWE) is playing a larger role. A lot of companies are looking at both RWE and observational data to identify patients by using information about demographics to attract the people in the sub-group. RWE should be able to play a role as long as access to medical records is adequate, which isn’t always the case. For example, in the US, electronic medical records are more geared towards billing, which makes it difficult to get useful clinical information from them. 

The use of digital data has a strong emphasis on decreasing the number of sites for a trial recruiting more patients. All at the same time that precision medicine is going in the other direction to increase access and expand the site pool. What is your perspective on decreasing this dissonance? 

This is certainly a dilemma because precision medicine increases the number of sites recruiting fewer participants. At the same time, use of metrics and other factors focus on sites with better track records and higher performance. These are counterbalancing trends. Precision medicine inevitably means you can’t reduce the number of sites and get more patients. 

How can sponsors proactively consider diversity during protocol development and study design? 

Patient advisory boards are one way. Another is speaking with subject matter experts who can review and provide feedback. Talk with sites – engaging sites will give additional feedback. Sponsors can also set targets, so that they are proactively addressing the need for diversity. For example, differences in metabolism by different ethnic populations could be the basis for a target. 

What are some ways in which we can make protocols easier to understand? 

For one, protocols can be written in more plain language. Soliciting input from patient or advisory boards to review draft protocols will provide a good perspective. Training is also a route to more understanding. Sites need to be trained properly. And that doesn’t mean training just once, it needs to be a continuous effort. It is also a good idea to make available a clear communication channel with sites, CROs and sponsors, so that questions can be asked and answered right when they are needed. 

Do decentralized clinical trials have the potential to further marginalize underserved communities, empower them, or is it a mixed story?

Decentralized trials give us the chance to conduct trials wherever we can meet participants. This increases the chance to get more representation when you are not limited by physical boundaries or in-person visits. But it has the potential to marginalize communities who are less likely to have good access to the modern technology. However, if you design decentralized trials specifically to address the challenges of diversity and technical obstacles, it can be empowering. Just applying a vanilla model of decentralized trials isn’t going to work. 

How can companies build trust in the Black community to encourage participation in research? 

This is a multi-pronged approach that includes education, more information and transparency. By engaging the local community, such as churches, community centers, etc., there is a chance to change the public perspective. There is also a need to educate and share more information with patients and their families. And HCPs also need more information about clinical research, so they can help debunk myths and refer more of their patients to relevant clinical trials. In general, greater transparency in clinical trials will go a long way to build confidence and trust in clinical research.

What resources are needed to help educate both patients and healthcare professionals (HCPs) on the importance of having diversity in clinical trials? 

There is a need to actively campaign and raise attention in the media. Historically, public perception of clinical research and the pharma industry in general hasn’t been very good. Now, with COVID-19, there is a chance to change this perspective. So, we need to educate the public on why clinical trials need a mixed representation of participants and raise awareness with HCPs. There needs to be a comprehensive approach that mixes curricula with peer review publications and public education. 

No One Left Behind: Addressing Clinical Trial Access and Issues Blocking Physician Participation

Expanding Clinical Trial Accessibility for Greater Inclusion and Diversity

Considerations for Physicians Interested in Becoming Clinical Trial Investigators

FAQ on clinical trial accessibility to improve inclusion and diversity

FAQs about Clinical Trial Accessibility | Clinical Trial Resources | Teckro

FAQ - post webinar

FAQ: Considerations to Overcome Clinical Trial Accessibility Challenges

What therapeutic areas does Teckro support?

Teckro supports all therapeutic areas in all phases. We have experience with studies in multiple disease areas, including oncology, CNS, cardiovascular, respiratory, metabolic disorders, dermatology, and GI.  We also have many COVID-19 trials live on Teckro.

Teckro clinical trial software is used by investigators, research site staff, monitors and sponsors. 

What are the main benefits of Teckro for sponsors? 

We find that Teckro is a differentiator for sponsors trying to secure the best research sites. They become the “sponsor of choice” with research staff because Teckro makes their job easier.  Sponsors also gain visibility sooner into issues blocking sites so they can proactively take action. In the end, sponsors can reduce time to market by improving clinical trial operations with Teckro. 

What are the main benefits of Teckro for monitors?

With Teckro, communication is significantly improved among monitors, research sites and sponsors. Everyone can be kept informed in real-time of critical study changes and other essential guidance. Monitors can also better plan site visits and focus on sites that need the most help.

What are the main benefits of Teckro for research sites?  

Sites using Teckro enroll the right patients faster and have fewer protocol deviations and violations. Because the protocol is always available from any digital device, investigators can better address potential patient safety issues – even if they receive a query in the middle of the night.

From any digital device, any study team member (such as principal and sub-investigators, study coordinators or CRAs) can enter a query in the search bar. This can include anything from amended eligibility criteria, specific procedures for a given visit, or dose modifications. Relevant, accurate answers from approved study documents are returned in seconds by analyzing all trial information in Teckro. Study managers can see what is being searched, when and by whom, which could point to the need for clarifications or show early indications of potential safety issues.

When there are study updates or changes, Teckro messaging delivers targeted communication by individuals, roles, sites, or countries.  Users are alerted by a push notification to their mobile device or through in-app messages, so they don’t miss important communication.  Site staff can also initiate messages to medical monitors or other study team members for additional guidance. Teckro is compliant with industry regulations, including 21 CFR Part 11, and messages can be exported for inclusion in your TMF.  

Teckro is accessible from a secure mobile application for Android or iOS smartphones, which can be downloaded from the usual app stores. Users can also log into a secure web application from the Teckro website. New users register their account in a couple of quick steps.

How are users know what studies they have access to with Teckro?

Study teams determine what sites and what users should have access to a given study. It is easy for users to switch between studies if they are on multiple with Teckro. 

Any documents the study teams want can be added to Teckro. Typically, this includes the protocol along with other key documents, such as the investigator brochure, lab manual, pharmacy manual, monitoring manual, etc. Videos, images and links to other external content, such as training material can also be added to Teckro if requested.

What happens when there is a protocol amendment? 

Study teams provide us with approved protocol amendments or updates to other study documents. These updates are implemented in Teckro, then we release to users on a site or country-level as IRB/EC approval is received. 

FAQ Teckro clinical trial software - usage by therapeutic areas, phases of trials, and benefits for sponsors, monitors, and research staff.     

FAQs about Teckro | Clinical Trial Resources | Teckro

Frequently Asked Questions: What is Teckro?

Frequently Asked Questions: About Teckro

Teckro connects study stakeholders with critical information they need, when they need it. This means investigators and research staff have immediate answers on hand when they are with patients. Monitors can better communicate study changes and provide useful guidance to sites. And sponsors have real-time visibility into site engagement and search trends, which could give early indications of risks or the need for clarifications. 

Watch this introduction to see how research staff, monitors and sponsors “Teckro the answer” to their clinical trial questions. 

This Teckro product introduction video explains how to “Teckro the answer” for study questions.

Video: Product Introduction | Clinical Trial Resources | Teckro

Video: Product Introduction

Video: Teckro Product Introduction

Clinical trials should be accessible to the population suffering from the illness. However, underrepresentation in clinical trials by racial and ethic minorities continues to be a multi-layered problem. 

Cassandra Smith, Director of Diversity and Inclusion in Clinical Trials Lead, Janssen R&D looks at why a changing global population requires more clinical trial diversity for the future of drug development and what role sponsors can play to make trials more accessible to all patients. 

Cassandra originally presented this segment in a longer webinar addressing clinical trial inclusion and diversity titled "No One Left Behind: Addressing Clinical Trial Access and Issues Blocking Physician Participation."

Webinar: Achieving Diversity and Inclusion in Clinical Trials

The original full-length Webinar, including a roundtable discussion and Q&A session.
Viewing Time: 80 minutes

Further reading on the topic of clinical trial diversity.

In this webinar, Cassandra Smith of Janssen looks at the lack of clinical trial diversity and how sponsors can improve accessibility for greater inclusion.

Webinar: Diversity and Inclusion in Clinical Trials | Teckro

In the last decade, protocol design has become increasingly complex with significantly more endpoints, inclusion/exclusion criteria and distinct procedures. Still, research staff are heavily reliant on paper and desktop computers to access the protocol instruction. Ken Getz, deputy director for the Tufts Center for the Study of Drug Development (CSDD) presents the current state of protocol design and complexity facing investigative research staff. 

Full results are available in the new report Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices. To request a copy, please complete the form below. 

Ken originally presented this segment in a longer webinar addressing clinical trial inclusion and diversity titled "No One Left Behind: Addressing Clinical Trial Access and Issues Blocking Physician Participation."

Webinar: Investigative Site Protocol Administration Referencing Practices

Read more about the report, including a summary of findings.

Industry Report: Investigative Site Protocol Administration Referencing Practices

This companion analysis provides Teckro's point of view on the research.

The Digital Paradox: Research Sites and the Clinical Trial Protocol

The original full-length Webinar, including a roundtable discussion and Q&A session.

Tufts CSDD Deputy Director Ken Getz presents research on investigative site staff accessing and referring to protocol information.

Webinar: Investigative Site Experience Accessingand Referring to Protocol Information

We know the protocol is the blueprint of any clinical trial. But do we know how and when it is referenced in the administration of a trial or when issues arise?

To answer these questions, the Tufts Center for the Study of Drug Development (CSDD) and Teckro collaborated on industry research on protocol perceptions from investigative research sites.  The results are published in the new report Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices.  

Paper copies of the protocol are still prevalent, though they tend to be stored away from the clinic area where patients are seen. 

There is little uptake of online portals, either for protocol instructions or study updates. 

There is a reliance on direct communication with the study monitor or clinical teams, but this means it takes time to get answers. 

There are clear differences in which sections of the protocol are regularly referenced and some are not as helpful as others.  

There is an opportunity for portable formats to provide more dynamic and real-time access to the protocol for improved safety and more effective recruitment. 

“The study results indicate that the majority of investigative sites are using unsophisticated approaches when referring to the protocol to guide clinical trial administration. This is not surprising given the high proportion of sites that are inexperienced, with minimal infrastructure, and — in many cases — involved in clinical trials as a supplemental activity to their clinical practice,” says Ken Getz, Deputy Director of the Tufts CSDD. “As clinical trial activity becomes more virtual and remote, facilitated in part by the pandemic, we expect to see investigative sites using more mobile, flexible technology solutions offering dynamic data updated in real time.”

To request a copy of the report, please complete the form below. 

This infographic provides a snapshot of the research.

Infographic - The Digital Paradox: Research Sites and the Clinical Trial Protocol

Ken Getz from the Tufts CSDD introduces the research as part of a panel presentation.

Ken Getz and Tufts CSDD introduce new study on how and when investigate site staff reference clinical trial protocols

Ken Getz Deputy Director of the Tufts CSDD | Teckro  

Tufts Summary Report

Infographic_Investigative_Site_Protocol_Perceptions_Study_July_2020.pdf

Teckro teamed up with the Tufts Center for the Study of Drug Development (CSDD) to capture feedback from research site staff on how they interact with the clinical trial protocol. In total 228 staff participated, and the results are published in Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices. 

This infographic provides a snapshot of some of the key findings.

Infographic of the Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices

Infographic Tufts CSDD - Teckro 2020 Study 

Infographic of Tufts research

Infographic: Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices

The_Digital_Paradox_Research_Sites_and_Clinical_Trial_Protocol_July_2020.pdf

In addition to the official report published by Tufts CSDD, we prepared a companion analysis. This analysis is broken into three observations from research: 

The conduct of clinical trials is guided by “electronic paper”

There is a degree of separation between the protocol and the patient

Study design complexity presents challenges for staff to find answers in the protocol

You can download our analysis by clicking the button below. We of course invite you to read the report yourself for your own conclusions. The full report can be requested by completing this form. 

The research shows that investigative site staff reference the protocol online via a desktop computer, through hard copies, and by asking study monitors. The process by which site staff find information from the protocol is electronic, but it lacks the accessibility, convenience and immediacy typically associated with digital. 

There are a few contradictions. For example, while the protocol may be electronic, it is most often referenced via a desktop computer in a fixed location. Questions are commonly answered by scrolling through the index to find a page number or by asking someone else. And while the most commonly accessed sections of the protocol are eligibility criteria and schedule of visits, the protocol doesn’t tend to be stored where patients are seen. 

Research staff are interacting with the protocol more as “electronic paper” than as a digital resource. This is illustrated first by the fact that the protocol is most often referred to on a desktop computer. Very rarely are respondents using mobile devices, such as tablets or smartphones. Considering that most are scrolling through an index to find a page number, it is not surprising that they aren’t accessing the protocol via devices with smaller screens. Even the modes of search are manual – looking up a page number, scrolling through perhaps dozens of instances of a keyword search, or asking someone else. 

In some ways, a desktop computer is perhaps even less convenient than paper in that it is in a fixed location. While staff may think they are “digital” because they are referring to an online version of the protocol, truly digital would be untethered access with instant, contextually aware answers to precise questions rather than broad brush category references. It’s the difference between finding the page number for the schedule of assessments section and getting answers on what specific procedures must be performed during Visit 3. 

The protocol is treated more like a static reference, rather than a real-time resource to guide the conduct of clinical trials. Patients’ lives have adapted to include the investigational products of clinical trials, they’re living with – and possibly because of – these treatments. AEs don’t know office hours, they can impact patients at any time, which therefore necessitates that research staff have immediate access to quickly and correctly make decisions. 

There are inefficiencies and time lost in providing answers for research staff when they are engaged with a patient. Typically, physicians won’t have more than a few minutes with a patient to determine if he or she is eligible, and for which clinical trial. If information is not readily accessible, this can lead to challenges with enrollment, which we already know is a problem for many sites.

The way research staff find answers in the protocol is time consuming and manual. Managing toxicity and adverse events are typically guided not only by sponsor SOPs but also other regulatory and safety reporting guidelines. As a result, these sections of the protocol could have potentially confusing or contradictory instructions when considered against these other sources. 

Medical monitors are not frequently a direct source of information for sites. With the CRA often as the intermediary between sites and medical monitors, this delays answers and also limits the visibility of medical monitors into the trial performance. 

Benefits for Investigative Research Staff

Electronic and digital aren’t the same thing. So, what does it mean when the protocol is digital? We believe that answers are available in seconds, contextually aware, and present with the patient. 

In the digital world, you ask a question and you get an answer. Under the covers, the search engine is analyzing all of the available information to generate the most relevant results – in seconds. 

In clinical trials, there are multiple questions. And answers may come from a variety of documents beyond the protocol, including investigator brochures, lab manuals, CTCAE, etc. 

What if any research staff could type a question into a search bar from any digital device and the results are returned in seconds after analyzing all available documents? The focus then shifts to the best answer instead of what section of a document. It reduces the burden on the user because the best answer is found among all of the documents. And it also eliminates any worries about document version because answers are only returned from the approved, current protocol for that site. 

Let’s take the example of “hypertension.” It may be part of the eligibility and so it may appear in either the inclusion or exclusion criteria of the protocol. But if during the trial a patient develops hypertension, the word could also appear in the toxicity management section of the protocol. 

A simple scroll through the index of a PDF directs the user to a list of topics but doesn’t necessarily answer the specific question. Similarly, doing a keyword search in a PDF would return multiple hits to the keyword, which then puts the onus on the user to look at the context of each instance of the word. 

What if a physician could just type in eligibility 140/90 – and get an answer whether the person is eligible for a clinical trial? Or dose 160/95 to understand whether to modify dosage based on the current blood pressure levels? Physicians and nurses can spend less time and be more precise to find answers in the context of their questions. 

Time with patients is limited. Decisions need to be made quickly and in compliance with the protocol.  Whether the patient is eligible for a given clinical trial, what conmeds are permitted, and which procedures should be performed for a given visit, investigators and research staff need to make decisions from the latest study information. 

From any smartphone or digital device, answers from the protocol are always where the patient is. This means physicians and nurses can focus on patient care. For example, protocols may be amended to update enrollment criteria. Therefore, it is critical investigators and research staff have the latest study information when they are with patients to enroll the right study participants and reduce errors. Gone is the need to walk to another room to log into a computer or flip through paper. 

If sponsors and monitors aren’t asking how research sites are interacting with the protocol, they should. 

Resources

Industry Report: Investigative Site Protocol Administration Referencing Practices

Webinar: No One Left Behind - Addressing Clinical Trial Access and Issues Blocking Physician Participation

Adapting Clinical Trial Operations in Response to COVID-19

No More Paper, No More Portals

Real-Time Site Feedback Guides Sponsor Decisions

Infographic: Our Journey over 5 Years

Video: Our Journey over 5 Years

Video: Teckro Corporate Story

ACRP White Paper: The Impact of Increased Technology Use on the Clinical Research Workforce

FAQ: Considerations to Overcome Clinical Trial Accessibility Challenges

Frequently Asked Questions: About Teckro

Video: Teckro Product Introduction

Webinar: Achieving Diversity and Inclusion in Clinical Trials

Webinar: Investigative Site Experience Accessingand Referring to Protocol Information

Industry Report: Investigative Site Protocol Administration Referencing Practices

Infographic: Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices

Analysis: The Digital Paradox: Research Sites and the Clinical Trial Protocol

FAQ: Considerations for Physicians Interested in Becoming Clinical Trial Investigators

Webinar: No One Left Behind - Addressing Clinical Trial Access and Issues Blocking Physician Participation

Webinar: Is Your Clinical Trial Protocol Really Fit for Purpose?

eBook: Is Your Clinical Trial Protocol Really Fit for Purpose?

Expanding Clinical Trial Accessibility for Greater Inclusion and Diversity

Webinar: Advance Clinical Trials and Tackle Cancer by Connecting Research Sites, Sponsors and Monitors

Solution Overview: Accelerating Infectious Disease Research in Response to COVID-19

Demo: Accelerating Infectious Disease Clinical Trials

Solution Overview: Supporting Clinical Trial Continuity during COVID-19 Pandemic

Adapting Clinical Trial Operations in Response to COVID-19

Demo: Supporting Clinical Trial Continuity during COVID-19 Pandemic

Every clinical trial starts with a question

Resources

Industry Report: Investigative Site Protocol Administration Referencing Practices

Webinar: No One Left Behind - Addressing Clinical Trial Access and Issues Blocking Physician Participation

Adapting Clinical Trial Operations in Response to COVID-19

No More Paper, No More Portals

Real-Time Site Feedback Guides Sponsor Decisions

Infographic: Our Journey over 5 Years

Video: Our Journey over 5 Years

Video: Teckro Corporate Story

ACRP White Paper: The Impact of Increased Technology Use on the Clinical Research Workforce

FAQ: Considerations to Overcome Clinical Trial Accessibility Challenges

Frequently Asked Questions: About Teckro

Video: Teckro Product Introduction

Webinar: Achieving Diversity and Inclusion in Clinical Trials

Webinar: Investigative Site Experience Accessing and Referring to Protocol Information

Industry Report: Investigative Site Protocol Administration Referencing Practices

Infographic: Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices

Analysis: The Digital Paradox: Research Sites and the Clinical Trial Protocol

FAQ: Considerations for Physicians Interested in Becoming Clinical Trial Investigators

Webinar: No One Left Behind - Addressing Clinical Trial Access and Issues Blocking Physician Participation

Webinar: Is Your Clinical Trial Protocol Really Fit for Purpose?

eBook: Is Your Clinical Trial Protocol Really Fit for Purpose?

Expanding Clinical Trial Accessibility for Greater Inclusion and Diversity

Webinar: Advance Clinical Trials and Tackle Cancer by Connecting Research Sites, Sponsors and Monitors

Solution Overview: Accelerating Infectious Disease Research in Response to COVID-19

Demo: Accelerating Infectious Disease Clinical Trials

Solution Overview: Supporting Clinical Trial Continuity during COVID-19 Pandemic

Adapting Clinical Trial Operations in Response to COVID-19

Demo: Supporting Clinical Trial Continuity during COVID-19 Pandemic

Every clinical trial starts with a question

Webinar: Investigative Site Experience Accessingand Referring to Protocol Information