Why AstraZeneca and Novartis Are Reshaping Their Clinical Trial Feasibility Process?
The Rising Need Of Having It All-In-One
I am truly glad to be part of this clinical research society 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 trend I see with you. Pharma companies, traditionally setting the standards in the drug development industry, are looking for to change a very traditional and yet conservative process — the Clinical Trials Feasibility. And I would love to hear your opinion.
Why Do We Need To Revise Feasibility Processes?
When we mention running a feasibility for clinical trials, we usually think of site feasibility or, in other words, reaching out to the sites and asking / assessing their capabilities and patient prediction. However, Request-For-Proposals (RFP) usually have not more than 14 days before they need to be submitted by the CRO or pharma country manager. Often this means relying solely on historical data or calling Key Opinion Leaders (KOL) in the country 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 that I have been advising on patient recruitment have decided that they can no longer accept these results. AstraZeneca, Merck, Pfizer, Novartis and even smaller biotech companies have started speaking and focussing on actual patient engagement to improve their patient recruitment and retention.
The first step is done — patient involvement in the protocol development. And though this improves the conditions on how patients participate in a study, it does not change the way countries and sites are being selected. Therefore, some challenges still remain.
What Else Can Be Done?
As my team and I are working on a platform helping sponsors and CROs to better plan clinical trials internationally, I have been discussing the challenges with both AstraZeneca and Novartis. Both companies have recognised that patient involvement is just a starting point.
A more efficient approach to look looking at sites, investigators, KOLs, startup timelines, ongoing and past clinical trials, etc. is required. Even though they have specialised 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 assessments of internal capabilities is separated from the analyses of the external landscape, because the data is located in different places / departments, etc. The global feasibility team relies on the local clinical operation 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 assessments of local investigators regarding the success of the study, which might be driven by the desire to run the study instead of a close-to-reality assessment 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 All-In-One Place?
Feasibility teams from both companies stressed that the Big Picture is fundamental first step to plan successful clinical trials and prevent delays. After understanding the Big Picture, a more in-depth detail 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
These are complex information and most of the details are gathered through back and forth communication between departments. There is also a need of 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 thoughts and work on improving the Feasibility Assessment.
If you would like to see how we combined this data, you can reach out to me. I would love to show you our solution and hear your ideas. Please also share your thoughts on best practices to improve the way we run feasibility, I am always interested in the comments.
