Adverse consequences of poor patient adherence in clinical trials
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Adverse consequences of poor patient adherence in clinical trials Poor patient adherence in clinical trials may explain the increased unexpected toxicities from prescription drugs that have been on the market for years, according to a review of clinical trial data by the President and Chief Executive Officer of Consumer Health Information Corporation, Dr Dorothy Smith. Over the past 10 years, Dr Smith had noted that the US FDA had withdrawn or reduced the dosages of several established drugs because patients had developed unexplained adverse events. Over the same time, media attention and patient education have led to better adherence to medication. Consequently, Dr Smith reviewed 20 years of patient adherence research in clinical trials to determine if there was any link between these events. She found that, between 1997–1999, 53% of clinical trials did not monitor patient adherence. Of note, up to 30% of patients did not take the full dose of the study drug, and about 50% of patients did not tell the study team that they had missed doses. Also of concern was the fact that patients did not understand 35%–94% of the Informed Consent Documents. "Many study patients do not realize that missing doses could endanger the lives of millions of people after the drug is approved", says Dr Smith. She also warned that unexpected adverse events could occur when patients in the real world are more compliant than those in clinical trials. "Patient adherence in clinical trials must always be higher than that of the general population. Our challenge is to get patient adherence in clinical trials up to 95% so patients can be assured it is safe to take the FDA-approved dose", concludes Dr Smith. Consumer Health Information Corporation. Consumer Health Information Corporation Warns Poor Patient Adherence in Clinical Drug Trials May be Putting the Public at Risk. Media Release : 12 Feb 2013. Available from: URL: http:// 809146493 www.consumer-health.com
0114-9954/10/1440-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 23 Feb 2013 No. 1440
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