Does noncompliance by clinical trial participants put future patients at risk? The Consumer Health Information Corporation says there might be a link between participant nonadherence and postmarketing safety issues.
According to an article recently published in the Drug Information Association’s Drug Information Journal, as many as 30% of clinical trial participants don’t take their study medication correctly. If nonadherence isn’t reported and addressed, the trial data may be flawed, and the approved dose of the drug may be too high for safe real-world use.
The author suggests:
- Educating participants that their level of medication adherence needs to be higher than that of the general population
- Ensuring that consent forms and other written materials are easy to understand
- Providing diaries, reminders and other tools to help participants comply with the protocol
- Creating an environment in which participants can provide honest feedback to study staff about their experiences in the trial
The alternative – increasing sample sizes to account for nonadherence – would make clinical research more expensive and further delay the provision of new treatments to patients who need them.