Patients in Clinical Drug Trials May Be Putting the Public at Risk July 3, 2012 By 


Every person taking a prescription drug assumes that the recommended dose is safe. Consumer Health Information Corporation suggests there could be a link between nonadherence of study patients in clinical trials to unexpected adverse drug effects and personal injury cases in recent years. If a person taking a prescription drug is more adherent than the study patients in the clinical drug trial, the recommended dose might be too high for that person.

Dr. Dorothy L. Smith, author of “Patient Adherence in Clinical Trials: Could there Be a Link to Postmarketing Patient Safety?” recently published in the Drug Information Journal, reviewed the last twenty years of research on patient adherence in clinical trials. The research has shown that up to 30% of clinical trial participants are missing doses and not taking the full dose. In order for study investigators to determine the safest recommended dose, it is critical that patient adherence in clinical trials is greater than that of the general population.

The problem is worsened, according to Dr. Smith, when study patients do not tell clinical investigators that they have missed doses and do not give honest feedback. These patients want to “please” the study team and/or do not want to be removed from the study. Electronic prescription caps have offered a solution but do not address the whole problem of patient adherence. The computer chips in these prescription containers accurately monitor when a medication is removed from the container but cannot monitor whether the patient actually administered the study drug or discarded it. Ultimately, it comes down to patient behavior and decisions that study patients make.

A clinical trial could be well-designed but a 20% to 30% decrease in medication adherence may require that the sample size be doubled in order for the study results to be accurate. If this is not done, the research results will be flawed and the dose recommended for the public could be too high. Read More