Several sources have recently pointed to possible links between poor patient adherence during clinical drug trials and unexpected adverse effects—as well as personal injury cases—once the drug is approved and marketed. Chief among these sources is the Consumer Health Information Corporation (CHIC), which recently posted a PRWeb article on the subject.
The CHIC release points to the work of Dr. Dorothy L. Smith, who authored, “Patient Adherence in Clinical Trials: Could there Be a Link to Postmarketing Patient Safety?”, recently published in the Drug Information Journal. In the article, Smith summarizes 20 years of research on patient adherence in clinical trials; among her observations is the unsettling fact that up to 30% of clinical trial participants miss drug doses and/or do not take the full dose. Smith also claims that the problem is exacerbated by patients’ failure to fully disclose the dosing issues to doctors who must evaluate the drug’s safe and effective dosing range for the general patient population.
Skipping or cutting drug doses can result in a substantial overestimation of that optimal dosing range. Patients in the post marketing population who assume that their dosing regimen has been proven safe and effective might incur unexpected adverse effects and potentially serious pathologies due to their adherence to an overestimated dosing range.
Poor adherence can be combatted by dramatically increasing the sampling size of clinical trial participant populations; however, this can be extremely expensive (and in most cases impossible) for many sponsors, investigators, and small businesses managing clinical drug trials.
Instead, Smith and others have suggested that the solution lies in increased communication: educating the participating trial population about the critical nature of their role in the trial and their strict adherence to dosing schedules—not merely for their own health, but for the benefit of all patients who will use the drug in the future.
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