One of the most critical aspects of the clinical trial process is recruiting the required number of patients. Under-enrollment can affect the scientific validity of a study, raise ethical concerns, and even cause premature trial termination, leading to a waste of time, resources, and money. For a trial, this is an unmitigated disaster, but it is avoidable.
Importance of Patient Recruitment for Successful Trials
Patient recruitment for clinical trials requires considerable planning, evaluation, and revision. Efficient recruitment of evaluable patients is necessary to ensure successful and timely completion of trials, specifically those which have additional inclusion criteria that make enrollment more difficult.
One thing that should always be considered is to recruit patients from different ages, genders, races, and ethnicities. This helps to not only expand a recruiting pool, but also to extrapolate clinical trial findings to a broader population and help discover important safety information about the investigational product.
For instance, many older adults have different health needs from those of younger people. They may also react differently to certain medications, have different side effects, and need varied dosages to produce the intended result. Hence, enrolling older adults in trials can enable researchers to develop appropriate treatments for this specific age group.
Cost of Patient Drop-Outs
We’d be remiss if we don’t mention the alarming cost of patient drop-outs and the importance of identifying patients likely to stay the course. Across trials, about 30% of patients drop out, resulting in heavy financial losses for sponsors. The cost of recruiting a new patient to replace a drop-out is far higher than the initial recruiting cost. Patients who exit trials can also cause expensive delays, resulting in losses of hundreds of thousands of dollars per day. In addition to the financial losses, drop-outs can lead to a loss of valuable data, insufficient results, and even trial discontinuation.
Challenges in Patient Recruitment
Recruiting patients is often considered the most challenging part of trials. Patient enrollment is rarely completed on schedule, as it can be difficult to identify a strong enough pool of eligible patients in specific locations, particularly for rare diseases. Enrolling adequate numbers of elderly patients is also challenging due to frailty, disability, and comorbidities. Slower than expected patient recruitment ultimately results in delayed drug development and loss of revenue.
Unfortunately, those challenges are just the tip of the iceberg. Other challenges include:
- Lack of awareness of trials among potential patients
- Unfamiliarity with what clinical research entails
- Little to no education and knowledge about diseases
- Poor outreach in underserved communities
- Under-representation of ethnic, racial, and minority groups
- Accessibility issues (lack of transportation to recruitment centers)
- Communication issues and language barriers
- Fear of study procedures, treatment side effects, and poor compliance with protocols
- Lack of support from physicians and/or family members
- Scheduling conflicts
- Financial, social, and religious issues
- Negative media publicity
- Ethical considerations in case of terminally ill patients or elderly patients
Strategies for Successful Patient Recruitment
Even considering such a daunting list of challenges, there are ways to overcome it. While it may seem elementary, much of it comes down to planning. Developing an effective plan which includes patient outreach strategies that fit in the budget and timeline is critical. Some trials extend patient recruitment periods by a few months to cope with stringent enrollment criteria and ensure that participants and their families fully understand the study, making them less likely to drop out. Other trials make sure they set aside ample funds to set up multiple multiple patient recruitment centers to help expedite the process.
Some of the most successful patient recruitment strategies include:
- Defining the target audience and ideal participant demographics based on protocol requirements and location
- Accessing and scanning an institution’s patient database or electronic health records
- Contacting primary care physician offices to obtain patient referrals
- Mass mailing personalized messages to candidates
- Running targeted media campaigns across newspaper, radio, television, and web
- Networking with anyone and everyone to create strong word-of-mouth
There’s no debating it. Finding enough fitting participants for a trial is just as difficult as it is imperative to success. Under-enrollment from the beginning and ongoing drop-outs can terminate a trial in the blink of an eye, leaving a major loss of money and even the loss of potential medications in its path. Implementing a proper recruiting strategy—and working with a clinical trial consultant or staffing agency to find the right talent to execute it—is paramount.
Read more strategies for overcoming staffing challenges in clinical trials here.