Alarming Statistics

 Clinical Trials, Patient Nonadherence Statistics


Make Sure Your Study Results Are Accurate:

“Patient Non-Adherence Increases Sample Size Requirement”

A 20% decrease in medication adherence may result in the need for a greater than 50% increase in sample size in order to maintain equivalent power.”

– Burke LE and Ockene IS. Compliance in healthcare and research. Futura Publishing Company, Inc.. New York. 2001:238.

In one study of asthmatic patients using an aerosolized medication, patients failed to write the truth in their diaries with over reporting of appropriate usage more than 50% of the time.

– Spector  SI, Klinsman R, Mawhinney H,. Siegel SC, Rachelefsky GS, Katz RM, and Rohr AS. Compliance of patients with asthma with an experimental aerosolized medication. Implications for controlled clinical trials. J Allergy Clin Immunol. 1986 Jan; 77(1Pt1)l 65-70.

“30% Of Patients Dump Study Drugs.”

One-third of the participants in the clinical trial dumped the contents of their inhaled bronchodilators before clinic follow-up visits in an effort to conceal their failure to take the medications correctly.

– Simmons MS; Nides MA ; Rand CS; Wise RA and Tashkin DP; Unpredictability of Deception in Compliance with Physician-Prescribed Bronchodilator Inhaler Use in a Clinical Tral. 2000. (August); Chest 118 (2); 290-295.”

If  30%  of patients are not using their medications at all or hardly using them, you could misinterpret data on the efficacy of a drug or overestimate the dose required to provide a desired effect.

– Patients in Clinical Trials Don’t Always Follow the Program., American Medical Association, September 11, 2000.”



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Our Expertise in Clinical Trial Patient Education Is Unmatched

Let us put our over 30 years experience developing patient education programs for clinical trials to work for you! 

Our team has expertise in:
  • Developing the patient adherence strategy
  • Developing all the patient materials for patient recrutiment and clinical trials
  • Writing clinical information in an empathetic tone that patients can understand and relate to
  • Developing “patient-friendly” informed consent documents
  • Incorporating protocol into instructional study materials for clinical investigators
  • Developing Patient Package Inserts (PPIs) that can be tested prior to the NDA submission and receive speedy FDA approval
  • Notarized translations in 104 languages that can be used internationally

Our team of patient education experts have years of experience counseling patients and have worked with pharma medical, legal, regulatory and marketing teams and FDA for the past 20 years. All of our materials are designed with a focus on patient compliance with the goal that patients will be motivated to remain in the study and will take the study medications correctly.

“Make sure your study results are accurate.”

Click here for more information about Patient Package Inserts (PPI)Patient Compliance ProgramsDisease Management Programs, Personal Progress Logs. For confidential consultation to discuss any of your clinical trial needs give us a call today at (703) 734-0650.