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Developing Regulatory-Compliant Patient Materials

by Felicia Fuller

Every study needs a voice — messaging that communicates the trial sponsor’s core objectives. Patient recruitment professionals provide this through compelling content and artful designs that resonate with target audiences and inspire study participation. But beyond being current and compelling, study collateral must also be regulatory-compliant.

Though regulations vary slightly per country, generally speaking, patient-facing content that promotes an investigational product must make no expressed or implied claims of efficacy according to the Code of Federal Regulations Title 21, Sec. 312.7, Promotion and charging for investigational drugs.

That sounds simple enough, but the term “implied’ is subjective and open to interpretation.  So what is one to do? Imperial adheres to the following guidelines in developing patient-facing materials for global audiences.

Required Patient Content

  • A statement indicating a research study is being conducted
  • The disease or condition being studied
  • Key eligibility criteria in layman’s language, for example, liver instead of hepatic, heart instead of coronary, etc.
  • Contact information so potential participants can request more information

Additional Permitted Patient Content

  • The purpose of the research
  • The location of the research
  • The company sponsoring the research (if the client agrees to include this)
  • Whether the participant will be compensated for participation
  • Balanced statements of potential benefits and risks of study participation

Prohibited Content

  • Claims of safety or effectiveness
  • References to “free medical treatment” when the intent is only to say participants will not have to pay for taking part in the study
  • Undue emphasis on patient reimbursement by giving the dollar amount or through special text treatment, such as boldface, italics or underlining
  • Claims that the investigational product is approved by the FDA or other regulatory body for use in patients with the target disease or condition
  • Use of the term “new” unless qualified as a “new investigational medication”
  • Use of the term “treatment” in the context of the investigational medication
  • The compound name, unless it is currently approved and marketed for another indication and the sponsor approves of its use in the materials
  • Overly promotional terms such as groundbreaking, exciting, important, unprecedented, etc.

Graphic Requirements

To avoid subliminal implications of efficacy, avoid depictions of smiling faces or people who appear markedly healthier than the target population. For example, an advertisement aimed at patients with mobility issues should not feature images of people performing physically demanding feats, such as mountain-climbing.

When in doubt, err on the side of caution and consult your patient recruitment provider or regulatory agency. For further information, visit www.fda.gov  

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