Solving the Problem of Clinical Trial Recruitment
Immunotherapy for childhood leukemia. Robotic-assisted surgery. Medications that decrease the risk of contracting HIV or clear the hepatitis C virus. None of these treatment breakthroughs would have been possible without successful clinical trials. Recruiting patients for these trials, however, can be a significant stumbling block that can delay trial startup and increase costs for the companies that develop these drugs and medical devices and ultimately for us, the consumers and patients.
How common are problems recruiting patients for clinical trials? A study by the Tufts Center for the Study of Drug Development found that 37% of sites in a given trial do not meet enrollment targets and 10% never enroll any patients. In addition, study timelines are doubled so that enrollment levels can be reached.
A lag in trial recruitment and the extension of trial timelines has several impacts:
- Financial: On average, delays cost $500,000 to $600,000 per month. That, in turn, increases drug development costs. To recoup those increased costs, pharmaceutical and medical device companies must increase the price of their products, boosting what patients and insurers pay.
- Delay in coming to market: Delays in FDA approval and bringing new products to market can open the door for competitive products, potentially reducing market share.
- Loss of investor confidence: As trial timelines expand and costs increase, investors may become concerned about the product’s viability and future profitability.
- Loss of investigator engagement: As investigators wait for months for the trial to enroll enough patients, they may shift their attention to other studies.
Understanding the Causes of Weak or Slow Clinical Trial Recruitment
There are 3 primary types of issues that contribute to problems with clinical trial enrollment: issues of time; issues of perception, awareness, and engagement; and issues of recruitment plan design.
- Startup delays and unrealistic expectations and timelines are the most significant factors in terms of issues of time.
- In terms of issues of perception, awareness, and engagement:
- Many studies fail to develop effective branding for the study or do not develop branding at all.
- Not engaging patient advocacy groups and being an active, visible presence in the patient community is another oversight.
- Not knowing how your company is perceived in the patient community can also impact recruitment.
- Sponsors that fail to take steps to keep investigators engaged throughout the recruitment and trial period may come up against low recruitment and retention numbers.
- Recruitment plan design and flexibility also impact recruitment success.
- Reliance on a standardized, inflexible recruitment plan is a mistake. There is no one-size-fits-all solution.
- Not developing and using analytics to track the performance of the plan means there’s no data to guide the adjustment of a plan that’s not working as planned.
- Patients who self-refer to trials often don’t make it to enrollment because there are no tools or processes to guide them through the process and no system in place to track them.
- Failing to recruit a diverse population of patients, including those in underserved, rural, and low-income communities, is another common weak spot in recruitment plan design.
Solutions and Strategies for Developing a Successful Recruitment Plan
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