Clinical trials are crucial in determining the effectiveness, safety, and adverse effects of various new drugs and treatment methods. They generate knowledge that can improve a patient’s quality of life and survival rates, showcasing their importance in healthcare.
However, the reasons contributing to clinical research trial failures, recruitment, and retention problems are among the most common. While patient participation is one of the pillars of successful trials, issues with enrollment and dropouts still cause premature termination, delays, and inconclusiveness of the trials.
To that end, this article explores patient recruitment barriers, their origin, and potential solutions. Keep reading to learn more.
The success of clinical trials depends on several important factors. Experienced and qualified investigators, funding, and equipment aside, they must have subjects. Trials must reflect the patient population that will eventually use the test treatment or drugs, making the pool large and diverse enough. Trial success also depends on patients with proper and timely enrollment and their participation in the research until they are complete.
These elements ensure trial findings are conclusive and relevant for the specific demographic of patients in need. They also help prevent trial delays, which result in additional financial, ethical, and schedule-related burdens to sponsors and researchers.
According to global data analysis within the Clinical Trial Database, over 50% of trials terminate due to low accrual rates. Patient retention percentages don’t look better, either. The number of patients remaining as the trial ends tends to be so small that the results end up inconsistent and unreliable.
Data such as this illustrates the urgency of finding a solution to patient recruitment issues in the clinical research industry. A good first step toward a resolution lies in identifying the source of the problem. With this in mind, the following paragraphs discuss the obstacles to patient recruitment in clinical research.
Barriers to patient recruitment exist on two levels — patient level and sponsor and site level. On the patient level, issues arise due to the following:
Patient Recruitment issues mostly emerge due to cost and time challenges on the sponsor and site levels. As mentioned in the beginning, the study population needs to be as representative as possible of the patient needing the test drug or treatment.
Therefore, time and resources must be spent on hiring proper investigators, finding appropriate investigational sites, developing strategies for engaging with patients, developing outreach materials, and so on. According to a US HHS study, accrual cost usually makes up about a quarter of all trial expenses. They also take up to 30% of the duration of the trial.
Sponsors can work on a few areas to help eliminate some barriers creating patient recruitment problems. They include:
Patient recruitment problems have been one of the most prominent obstacles in the clinical research industry. The pandemic made them even more pronounced, highlighting the need for their urgent resolution. While hindrances such as lack of awareness, mistrust, poor communication, and others are not insignificant, they’re not insurmountable. Strong campaigns and online strategies are a great start to driving engagement.