Discover the top 5 alarming statistics that highlight the challenges in clinical trial site selection. Learn how to optimize site choice and enhance trial success with BioBoston Consulting’s expertise.
The choice of clinical trials site is one of the key elements for the successful development of new drugs and therapies. However, the selection process if not done correctly can lead to costly delays, failed studies and suboptimal end points. This post digs down to the top 5 concerning numbers indicating the pivotal pain points in clinical trial site selection and details how stakeholders can avoid them all effectively.
1. Slashed Enrollment Goals:
Based on the data compiled in 1999, it is estimated that fewer than 20% of sites will meet their enrollment goals.
Clinical trial site selection — This limitation causes potential delays in trial timelines of longer duration and higher costs, as investigators fail to find sufficient number of patients. BioBoston finds suitable candidates and allocates adequate resources for retention. We speculate that low patient pools, lack of appropriate site selection criteria and suboptimal engagement with potential participants are some of the causes for failed clinical trials..
2. More Than 30% of Clinical Trial Sites do not research a single patient
Even more shocking is the stat that more than 30% of clinical trial sites do not recruit a single patient. One of the highlights from the above statistic is therefore site pre-feasibility and correct site selection. Besides the loss of resources, failing to enroll patient’s slowdowns the entire efforts for a clinical trial.
3. Source:
Although site selection is one of the major drivers in managing clinical trial timelines, 80% of trials face delays at this step due to issues with site selection. Identifying and solving these early on in planning is critical to keeping clinical trials on time and on budget.
4. Site Performance Varied by Up to 50%
At the end of the day, performance variability between clinical trial sites is quite large and is somewhere between 20 to 50%, meaning that some sites outpace others by a factor of two. This variance can negatively influence data quality, and trial outcomes and demonstrate the importance of choosing well-performing sites with excellent facilities.
5. Up to 40% of sites had High dropout rates
A further problem is high dropout rates: up to 40% of sites may report extensive participant attrition. If too many patients drop out, the validity of the trial is compromised and it may produce inconclusive or incorrect results. While this issue is best protected by effective patient engagement strategies and continued support of trial participants.
How to deal with these difficulties utilizing Consulting Firms
Because of the level of difficulty and importance associated with site selection for clinical trials, it can sometimes be best to work with specialized consulting firms. Biotech consulting firms, pharma consulting firms, and life science consulting firms provide the required skill sets and resources to optimize site selection process which in turn results in higher overall trial success.
Conclusion
Site selection for clinical trials is a complicated, yet integral part of the drug development process. These alarming statistics demonstrate the serious problems that exist in this process. But with this awareness and by working with the knowledge of consulting experts in this space, sponsors can potentially optimize their site selection strategy, not only improving trial execution but also speeding therapies to market.
Reach out to BioBoston Consulting or visit our website for more information on how we can help your firm.
