Designing a compliant, patient-centric clinical trial

Listening to the voice of the patient early in the course of drug or device development can help Clinical, Commercial and Medical Affairs teams avoid many potential pitfalls, including slow study enrollment and surprise failure on endpoints.

Capturing patient experience data directly during the clinical trial process, through means other than patient-reported outcomes (PROs), can pose its own set of challenges. However, the pharmaceutical and biotech companies that have pursued this exercise with the help of an experienced third-party research partner have obtained valuable insights to inform their decision-making.

 Conducting compliant patient experience research

Many of the regulations regarding patient communications before or during clinical trials are designed to protect patient privacy, safeguard patient participation from influence or coercion, and ensure research objectivity. A well-designed clinical trial “market research”  study must align with those goals, complying with applicable regulations while answering the sponsor’s questions. Such research can provide insights that range from identifying potential barriers that could slow trial enrollment to suggesting useful patient support materials that improve the commercial launch.

Considerations include:

  • Timing: Patient experience data can be gathered at several points in the development process, depending on the goal. For example, some companies use advocacy and patient interview data before starting trials.  Some companies are gathering retrospective data from clinical trial patients after database lock, while others are beginning to obtain prospective data from patients during clinical trials, primarily during open-label studies.
  • Design: Options for soliciting patient experience data will be influenced by Institutional Review Board (IRB) protocol type, which in turn will be informed by company goals. For example, a study designed to generate publishable data may require a different type of IRB approval than a study aimed at improving depth of internal insights (i.e., quality improvement project).
  • Quality: Generating useful data begins with asking the right questions of the right population. In some cases, that population might be a segment of patients who declined consent, patients from certain sites or patients with sub-types of a condition. In some cases, the right population might be caregivers or parents/guardians. Asking the right questions is an art form that takes decades of experience interviewing key customers with painstaking care and dedication.

Experience supports success

Compliantly collecting patient experience data during the drug or device development process requires a complex skill set. In addition to being adept with market research and qualitative interviewing, the research partner needs an understanding of patient privacy laws, sponsor/investigator responsibilities, corporate compliance, and Clinical Development, as well as experience working with regulatory agencies. Clinical SCORE has a successful record of helping biopharma companies run more patient-centric clinical trials. To learn more, email Blaine Cloud or call (877) 334-0100, ext. 1005.