It’s an unfortunate reality in clinical research; oftentimes sites struggle to recruit subjects. Frustration trickles down from the principle investigator and on down to the coordinators as sponsors put pressure on sites to enroll, enroll, enroll. What are the barriers to recruitment and how can they be overcome?
A research study on the attitudes, barriers, and motivating factors in clinical research shows that hurdles to enrollment fall into four main categories:
- Subject related barriers
- Investigator related barriers
- Protocol related barriers
- Other barriers
Subject related barriers involve the subjects’ views on research. Often subjects have a fear of being a “guinea pig”. Experimentation fears are also prevalent which include the fear of getting a placebo and fear of the unknown. Age factors also affect involvement in research as elderly subjects are more reluctant to participate in clinical trials. Some subjects will reject research due to the role of significant others who oppose research or inadequate support from family and friends during the clinical trial. Location also becomes an issue as subjects may have transportation issues or do not live in close proximity to the study site. All of these factors can prevent eligible subjects from have the willingness to participate in a research study.
Investigator related barriers include the physician’s personal perception of trials, faith in the research, and providing patients with the option to participate in research. Often times, investigators have poor communication skills which does not allow them to convey the proposed research in a manner that makes the patient feel comfortable and at ease with research participation. The subject expects the investigator to be passionate about the research. But often times due to schedule conflicts and time constraints, the investigators do not have the time to dedicate to the recruitment of potential subjects.
Third, protocol related barriers can hamper subject recruitment. Study design can be a major issue; too many visits, too many complex procedures or invasive testing. Also, protocols can have too stringent eligibility criteria that are so tight that potential subjects do not qualify for entry. Lengthy study periods can also influence a subject’s willingness to enroll in a clinical trial. If a study needs data for 5 or 10 years, subjects are less likely to commit for this length of time.
Last, other barriers to recruitment include costly clinical trials that cannot obtain the proper funding, negative influences of the media regarding clinical research, and lengthy approval processes at the site. Subjects who were originally identified as eligible no longer meet eligibility criteria due to lengthy regulatory approvals. Also, a poor choice of site selection on behalf of the sponsor can have a negative impact on enrollment. This includes a lack of interest on behalf of the PI/study staff or the site cannot meet the requirements of the study protocol (e.g., advanced imaging, complex medical testing).
The above mentioned barriers are not new to research and afflict every trial and every site. Subject recruitment continues to decline as these barriers continue to exist and multiply. This increases frustration for sponsors as timelines are missed and funding runs low.
What has worked well for you in overcoming the many barriers to recruitment? We want to hear your ideas.