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 patient quality of life and survival rates while showcasing their importance in healthcare.
However, several common reasons contributing to clinical research trial failures include recruitment and retention problems. While patient participation is one of the pillars of successful trials, issues with enrollment and dropouts still cause premature termination, delays, and inconclusive trial concerns.
This article explores patient recruitment barriers, their origin, and potential solutions. Keep reading to learn more.
Why Is Patient Recruitment and Retention Important in Clinical Trials?
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.
Patient Recruitment and Retention Problems
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 in Clinical Trials
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:
- Lack of awareness— People typically learn about clinical trials in two ways. Patients get recommendations from their physicians or see campaigns and advertisements. However, neither of the two ways is particularly prominent, especially in poorer or underserved areas. Without this exposure, potential patients may not know that clinical trials are an option.
- Poor communication— When recruiting patients, investigators must introduce potential participants and their caregivers to the trial and its protocols. They usually do this by providing them with all relevant study-related information. However, patients will be less inclined to participate if the material isn’t clear and easy to understand.
- Fears about side effects or procedures— Clinical trials are experimental in nature and often involve risks and invasive procedures. Patients are discouraged from participating in clinical trials if these elements are not clearly explained.
- Travel issues— Trials often carry their research inside clinical research centers or similar sites. Participating in trials usually involves consistently visiting said locations over long periods. Patients often don’t enroll in trials or drop out because of mobility or financial restraints. They also find these visits disruptive due to their work schedules or other responsibilities.
- Mistrust in research, pharma, or healthcare— A large population of the public has negative views of clinical trials as a whole. This has created a problem that clinical research has been unable to overcome over the years. As a result, pharma and healthcare surveys have confirmed people tend to distrust those running the trial and question their motivation.
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.
Solutions to the Patient Recruitment Problems in Clinical Trials
Sponsors can work on a few areas to help eliminate some barriers creating patient recruitment problems. They include:
- Patient involvement— Lack of patient involvement is often a result of investigators’ or researchers’ poor efforts to engage with them. Openness and proper communication in the early recruitment process will make trials less intimidating and more accessible for patients. Moreover, marketing strategies that include social media, blogs, videos, SEO, and SEM techniques can do wonders for patient involvement.
- Trial complexity— Clinical trials’ complex protocols and demanding schedules often scare patients and caregivers off. Making the protocols, study design, and schedules more straightforward, and patient-friendly will help improve patient recruitment rates.
- Inclusion and exclusion criteria— Trial inclusion and exclusion rules tend to be very restrictive because the study population needs to be representative of the intended treatment population. However, researchers and sponsors should ensure that the eligibility criteria still allow for diversity. They can do so by placing more importance on selecting investigator sites.
- Lack of cultural training— Social and cultural barriers are one of the primary issues investigators have been dealing with when recruiting patients. Nevertheless, these obstacles can be surpassed with proper staff, well-designed strategies, and appropriately focused funding.
- Patient recruitment strategy— Many clinical trials get delayed or terminated due to a lack of or inadequate recruitment strategies. Putting more thought into this area can help improve recruitment rates and reduce overall trial costs.
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.