Recruiting patients for clinical trials is a crucial component of the drug development process, and a key factor in determining the success or failure of a study. However, finding the right patients is challenging, and many trial sponsors and clinical research organisations (CROs) turn to clinical trial patient recruitment companies and site databases to help identify and enrol suitable candidates. Of course, these resources can be helpful, but for certain types of trials, there are challenges associated with relying on them. In particular, trials looking for patients with particular biomarkers may be too specific to rely on a traditional patient recruitment company or a site database. In this blog, we review these challenges and alternative methods which may address them.
Biomarkers are measurable indicators of disease, such as genes or proteins, and they can be crucial for identifying eligible patients for precision medicine clinical trials. This is information that is typically absent in site databases and difficult for traditional patient recruitment companies to screen for. Without biomarker information, it can be challenging to accurately estimate the number of eligible patients and the optimal sites for recruitment. This can lead to an overestimation of feasibility and ultimately result in high screen failure rates, which are costly for researchers and frustrating for patients.
Additionally, relying on a high-volume approach to recruitment, which many patient recruitment companies favour, can have negative consequences for both patients and sites. Pushing a large number of patients to a small number of sites can result in site burnout and a poor patient experience. Importantly, this can damage the reputation of the trial and the sponsor.
The traditional clinical trial recruitment method is also focused on a singular study. But, running "one-drug one-trial" studies in isolation can lead to a fragmented approach to drug development, where multiple trials for the same condition are being conducted simultaneously without any collaboration or coordination. This can result in patients being lost when they screen out of one study and miss out on other potentially suitable trials.
Finally, relying solely on site databases and traditional patient recruitment companies for biomarker-intensive clinical trials can result in a lack of preparation for a drug launch. Even if a volume-based approach does succeed in enrolling enough patients to conduct the trial, it does not necessarily prepare the market for the launch of the drug. A successful drug launch requires widespread availability and knowledge of testing, which may require a more comprehensive approach to patient recruitment.
Despite these challenges, site databases and patient recruitment companies can still be valuable resources for identifying and enrolling eligible patients for clinical trials. However, it is important to use them in conjunction with other patient identification strategies such as genetic testing, and to carefully consider their limitations and potential biases. Developing a comprehensive patient finding protocol that includes a variety of recruitment strategies and layers in genetic testing elements can help ensure that clinical trials are representative of the patient population and produce reliable results.
To learn more about the unique approach Sano takes to enrolling and engaging patients in precision medicine trials, get in touch below.