Patients in Clinical Drug Trials May Be Putting the Public at Risk

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Consumer Health Information Corporation recommends that patient adherence in clinical drug trials must be higher than that of the general public. When it is lower, a person taking the recommended dose could be taking too high a dose and develop unexpected adverse drug effects and toxicity.

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 (Vol.46 No.1 Jan 2012), 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.

Patient adherence in the general population has been increasing due to major attention it has received from FDA, health care professionals, pharmaceutical companies, and insurance companies. Patients are now receiving better patient education because of the efforts of these organizations and health care professionals. Potential patient safety problems could arise when patient adherence in the general population exceeds that of the clinical trial. Depending on the specific medication and medical condition of the patient, there could be a higher risk of adverse drug effects including toxicity.

Dr. Smith urges that “Study participants need to understand the important role they play in the clinical trial and how their actions and feedback will affect the accuracy of the study results as well as the lives of future patients who will be taking the study medication once it has been approved.” She recommends that in order to protect the public:

  • Patient adherence in clinical trials needs to be increased to a level that will exceed that of the general population.
  • Clinical trials need to provide patients with information they can understand. The majority of Informed Consent Documents are written in language study patients cannot understand.
  • Study investigators must make it “easy” for patients to be more adherent with study medications. Medication instructions, reminders, compliance packaging, Smartphone Apps, texting, electronic patient diaries, patient logs are all tools that will motivate them to take the full dose of the medication.
  • Study patients need to feel “safe” to provide honest feedback to the clinical trial team regarding any problems they are experiencing with the study drug.

“It’s a sobering finding.” states Dr. Smith. “I have spent my career trying to help patients take their prescription drugs correctly and to take the recommended dose. Clinical trial investigators need to develop a compliance strategy that will increase patient adherence to a level that will not require an increase in sample size to maintain the power of the study. This will give health professionals assurance that patient safety is not in danger because the dose and adverse event profile would be based on a higher level of study patient adherence than would be expected in the general population after the launch.”

About Consumer Health Information Corporation

Consumer Health Information Corporation was founded by Dorothy L. Smith, Pharm.D, an internationally recognized clinical pharmacist with expertise in patient adherence and patient education. The mission of Consumer Health Information Corporation is to help patients learn how to manage their diseases and prescribed treatments safely and wisely. The company has developed more than 4000 evidence-based patient education programs for medications, medical devices, disease management and Phase III clinical trials worldwide. A respected clinical and educational source, Consumer Health Information Corporation has won major national and international awards for excellence in patient and consumer education programs that have significantly increased patient adherence. Dr. Smith is the author of more than 130 professional articles, 23 books and has delivered more than 150 professional and scholarly addresses.

Copyright 2012 Consumer Health Information Corporation. All rights reserved.
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