NOTE TO PHARMA: Focus on Patient Adherence in Clinical Trials Before Product Launch





Dr. Dorothy Smith


Patient dumping of study medications can lead to flawed data and serious problems.


McLean, VA — Dr. Dorothy L. Smith, President and CEO of McLean-based Consumer Health Information Corporation (CHIC) and a leader in patient advocacy, spoke about the importance of the patient’s role in successful therapeutic outcomes during clinical trials to an audience comprised of pharmaceutical industry executives, clinicians and researchers. She was invited to address the Pharmaceutical Industry session at the 2008 Annual Meeting of the American College of Clinical Pharmacy (ACCP) in Louisville, Kentucky.

Dr. Smith, a founding member of the ACCP, stressed that, “Research shows that many patients are overestimating their adherence and not providing the study investigators with honest self-reports. The study design may be flawless, but if the patient does not understand the medication instructions and is not motivated to take the study medications as prescribed, the results of the clinical trial might be flawed. Could this be part of the reason for the unexpectedly high adverse drug reactions and deaths that have made recent headlines and resulted in numerous post-marketing dilemmas?”

Research shows that:

  • More than 35% of patients do not understand the informed consent documents because they are not written in plain language.
  • It is estimated that up to 30% of patients dump study drugs. The main reason is that patients do not want to disappoint their doctors. This has a tremendous impact on study results. Data on the efficacy of the study could be misinterpreted or the dose required to provide a desired effect overestimated.
  • Studies show that just a 20% decrease in patient adherence requires a 50% increase in sample size to maintain equivalent power. This is extremely expensive for a pharmaceutical company. The most logical way to prevent this extra expense is to keep patients fully informed before and during clinical trials and to keep the lines of communication open at all times.
  • The resulting faulty data could lead to FDA approval of doses that are too high for the general population.

Smith urged the pharmaceutical industry and clinical pharmacists to make sure patients understand all patient information they need to participate in a clinical trial. This includes developing informed consent documents written in plain language, how to take the study medications and use any device correctly, and the need to be honest with the study investigators regarding any problems they are having taking the medication. Patients in clinical trials need to understand how important their study results are to the general population who will be taking the medication in the future.

Smith, an internationally-recognized leader in patient education, has overseen many breakthroughs in the industry. Yet, she says, there is much that still needs to be done to change the medication adherence paradigm because patients hold the power and can make or break the success of a product.

In summarizing her presentation, Dr. Smith outlined a series of critical steps for the pharmaceutical industry to improve patient adherence in clinical trials. “The industry is currently focused on post-launch patient adherence when in fact it should be concentrating on ensuring that patients in clinical trials are adherent. Product teams that start developing Patient Package Inserts (PPIs) and patient education programs in clinical trials will be the winners. They will be ahead of the competition at product launch.”

About Consumer Health Information Corporation

Consumer Health Information Corporation ( is internationally recognized for our innovative and evidence-based patient education programs that increase patient adherence. The company was founded to help bridge the communications gap between patients and health professionals. Starting with clinical trials, we continue through product launches, FDA-approved PPIs, and DTC/DTP educational programs. Our products enable companies to achieve maximum sales before their products go off patent. We have the depth and breadth of clinical expertise to research, write, design, perform comprehension testing, print and distribute patient information programs. For more than 25 years, our team of physicians, pharmacists and designers has produced a broad range of award-winning print and multimedia patient information programs for pharmaceutical companies, consumer organizations, health care professionals, medical offices and corporate wellness programs. These FDA-approved materials have helped millions of people learn to make wise decisions about their health and medicines.

We enable product teams to maximize sales by developing programs that patients can understand and trust. Our behavior modification and reinforcement methodologies motivate patients to stay in therapy and refill their prescriptions on time.

The company has served on the Board of Directors for the National Council on Patient Information and Education (NCPIE), the National Board of Advisors for the University of Arizona, College of Pharmacy, and the Dean's Advisory Council for the University of Cincinnati Medical Center, College of Pharmacy, and is also a teaching site for more than 30 schools of pharmacy across the United States.

About ACCP

The American College of Clinical Pharmacy (ACCP) is a professional and scientific society that provides leadership, education, advocacy, and resources enabling clinical pharmacists to achieve excellence in practice and research. ACCP’s membership is comprised of practitioners, scientists, educators, administrators, students, residents, fellows, and others committed to excellence in clinical pharmacy and patient pharmacotherapy.

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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Consumer Health Information Corporation  

Experts in Patient Education and Adherence Since 1983
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