Country and Site Selection for Clinical Trials Need to Change. What Is Driving the Shift?

I am truly glad to be part of this clinical research community that looks for opportunities and drives for excellence and innovation. Thanks to multiple conversations with my network of experts I can see signs of change. And because I believe that change comes from people, I am writing this article to share trends I see. Pharma companies, traditionally setting the standards in the drug development industry, are looking to change a very traditional and yet conservative process – Clinical Trials Feasibility.

Why Do We Need To Revise Feasibility Processes?

When we think about feasibility for clinical trials, we usually think of site feasibility or, in other words, reaching out to sites and asking/assessing their capabilities and patient predictions. However, Request-For-Proposals (RFP) usually come with a deadline of no longer than 14 days. Often this means that feasibility managers rely solely on historical data or call Key Opinion Leaders (KOL) in the target countries for quick advice.

This will lead to two main challenges:

  • Selected countries are not the best choice in terms of patient recruitment and timelines
  • Selected sites are often engaged with other trials and do not have the time, or the number of patients to conduct the study as predicted 

Outcome → 85% of clinical trials delayed, unsatisfied sponsors, fragmented market for CROs

Challenge Recognised – What’s Next?

Many big pharma companies I have advised on patient recruitment decided they can no longer accept these results.

AstraZeneca, Merck, Pfizer, Novartis, and even smaller biotech companies have started speaking and focussing on patient engagement to improve their recruitment and retention.

The first step is done – patient involvement in the protocol development. And though this improves the conditions for patient participation in a study, it does not change the way countries and sites are selected. Therefore, some challenges still remain.

What Else Can Be Done?

I have discussed feasibility challenges with both AstraZeneca and Novartis. Both companies recognized that patient involvement is just a starting point.

A more efficient approach to looking at sites, investigators, KOLs, startup timelines, ongoing and past clinical trials, etc. is required. Even though they have specialized teams and access to advanced databases and CRMs, they often look at all components separately first, which fractures the Big Picture.

I have been told that often the assessment of internal capabilities is separated from the analyses of the external landscape, because the data is located in different departments, etc. The global feasibility team relies on the local clinical operations team to provide the local picture.

However, local teams usually don’t have access to all the data, and to compare their country to other pre-selected countries. In fact, they often rely on the assessment of local investigators regarding the success of the study. This assessment might be driven by the desire to run the study instead of a close-to-reality grasp on:

  • How likely are patients to participate in this study?
  • How many competing trials are currently running / will be running at the start of my study?
  • How many patients do they actually have access to?

How About an All-In-One Place?

Feasibility teams from both companies stressed that the Big Picture is a fundamental first step to plan successful clinical trials and prevent delays. After understanding the Big Picture, a more in-depth analysis is required. To achieve this, all data should be available in one place.

Examples are:

  • Startup timelines
  • Standard of Care /Approved Drugs
  • Competing clinical trials
  • Experienced sites and investigators
  • Number of patients (both prevalence and EMR-based data)
  • Average Recruitment and Dropout Rate
  • Patient Communities landscape 
  • Clinical Trial awareness

This is complex information and most of the data is gathered through back and forth communication between departments. There is also a need for the right balance between in-house historical information and external data depicting the landscape and trends. This is why solutions take time. The good news is that we can learn from their example and work on improving the Feasibility Assessment.

With TrialHub we set out to change how feasibility is run so that clinical trials and new treatments can reach the patients who need them. On TrialHub you can access all of the data mentioned above and compare countries based on what really matters to you. Identify sites experienced in your indication, check out how much similar trials were delayed, find local patient organizations, and even consult local experts hassle-free.

First published on LinkedIn

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