A trial’s success depends largely on the ability to recruit and retain an adequate number of participants. Recruitment can be especially difficult in opioid clinical trials, due to a variety of factors.
Here are seven things you should know about the challenges associated with recruiting patients for opioid trials:
1. Certain necessary aspects of trial design may be unappealing to prospective participants, leading to low recruitment. Daily pain diaries, placebo groups, and current pain medication washout requirements can be a real turn off.
2. Due to the opioid abuse epidemic, high recruitment can also be a problem, too. To guard against abuse and drug diversion, insist on proper screening protocols to eliminate drug seekers, including documentation of pain history from medical and prescription records prior to enrollment.
3. On a related note, the geographic location of study sites is important to consider. Sites that are too close together can encourage drug seekers to attempt enrollment at multiple sites.
4. The normal waxing and waning of symptoms in pain conditions, as well as the natural tendency of pain to improve over time, can lead to high initial screening failure rates.