Ask almost any clinical research staff member, and they will say one of their biggest challenges when conducting a clinical trial is obtaining the correct number of participants. According to the National Institutes of Health (NIH), more than 80% of clinical trials in the U.S. fail to meet patient recruitment timeline goals.
If research staff fail to enroll enough participants into a study, that will by default extend the study’s timeline, simultaneously increasing resource usage and costs. A prolonged study startup will delay a drug or treatment’s arrival to the market, extending the time it will be withheld from the general public.
Methods of Recruiting
If you are having a hard time recruiting participants, consider switching up your method of recruiting. There are many different ways to recruit participants, and each of them render success.
One method is recruiting all of the participants needed, enrolling them and starting the trial for all participants at the same time. Research subjects could also enter participants through a “batch” mode – meaning, a select number of subjects are added at any given time during an enrollment period. When the enrollment period closes, staff must wait to enroll new participants until the next period opens.
Other methods of recruiting include enrolling participants until sample size is met, and enrolling subjects up to a predetermined date. It’s important to remember, however, to account for subjects who may drop out.
Reasons for Non-entry
Even with a solid and successful recruiting method, there’s still room for participants to drop out, or to decide to not enter altogether. Reasons include:
- The trial’s procedure is difficult for the participant to understand
- Research staff has difficulty obtaining informed consent
- The trial’s treatment method isn’t the participant’s preferred method
As a research staff, it’s important to not only know the study in full, but to be friendly and empathetic when explaining it to potential participants. It will help you answer any and all questions your participant has, but it will also help put subjects at ease upon agreeing to enter the trial. This will initially help with enrollment, and the relationship built over time between the staff and subject will help diminish the dropout rate.
Ways to Retain Participants
Just like there are different ways to recruit participants, there are various techniques to retain participants. Agreeing to participate in the trial does not mean a participant will agree to keep going in a trial. It’s important to remember informed consent needs to be obtained consistently throughout the process, and a participant can opt out at any given time.
Not only is it imperative for the subject to understand the trial in full, but they must meet the inclusion/exclusion criteria of the trial. Oftentimes, however, the criteria can be too strict, greatly impacting enrollment. If recruitment is slow, it might be attributed to the narrow inclusion/exclusion criteria.
Keep in mind that participating in a clinical trial may be inconvenient for a subject. They may have to take additional time off of work or find someone to watch their children while they go to appointments. If your study can ethically give a monetary incentive, it might help to pay participants at the end of the trial in order to mitigate early withdrawal.
Metrics in Recruiting
In recruitment, tweaking your strategy is the first step, but it will only get you so far. It’s important to include metrics when you are recruiting for subjects, because it will help you in more ways than one.
Using metrics allows for research staff to:
- Plan for future studies
- Negotiate future budgets
- Better understand what the participant needs
- Report findings to internal stakeholders
Overall, metrics will allow you and your team to not only improve on current studies, but will pave the way for recruiting patients, securing budgets and running a successful trial.