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Don’t let noncompliant patients damage your clinical trial

Thursday, September 1, 2016

Just as misinformed assessors and readers can affect study viability, so can misinformed patients. With the ever-increasing costs of clinical studies, researchers can’t afford to let patient noncompliance damage results. To boost patient compliance:

  1. Improve informed consent doc­umentation.

Nearly 60% of people cannot read an informed consent document, which means they can’t truly consent to study protocols. Before distribut­ing an informed consent document to patients, ask a professional editor to review it for clarity and revise it for the appropriate reading level. This document should describe study goals, procedures to be performed, patients’ responsibilities and poten­tial conflicts of interest.

  1. Explain the rationale behind study protocols.

Patient adherence to prescribed therapies averages about 50%, but understanding the reasoning behind their therapeutic regimens can sig­nificantly improve compliance. For example, explaining the rationale behind a pain questionnaire ob­tained after dosing helps sponsors determine how effectively a drug re­lieves pain.

  1. Remind patients to complete study procedures using technol­ogy.

Missing time-point assessments are a common patient compliance problem. Fortunately, researchers can improve compliance by provid­ing electronic devices that remind patients of study protocol assess­ments. Researchers using electronic clinical outcome assessment (eCOA) smartphone devices can program procedures into the device to remind patients to dose medication, verify dosing, complete questionnaires, and more.

Patient noncompliance can risk years of drug development progress, but researchers can take steps to increase patient compliance. Com­pliant patients mean better data, a smoother drug approval process and better relationships between participants and clinical site per­sonnel.


Written by Guest Writer Joseph Pierro. Pierro is chief medical officer of Biomedical Systems, a premier global provider of centralized diagnostic services. He has served in global senior-level positions within the pharmaceutical industry and as a medical reviewer at the FDA Center for Drug Evaluation and Research. His thorough understanding of regulatory submission requirements and outstanding track record of success with regulatory approvals and responses to regulatory authorities make him an asset to Biomedical Systems’ Scientific Affairs team.

This article was reprinted from Volume 23, Issue 09, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>

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