When using genetic screening to identify clinical trial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Guidance in this area is much needed.
At Worldwide, this topic arises frequently in discussion with rare disease sponsors. As genome-wide association studies to identify genetic markers for common diseases increase, these questions will surface even more.
Consider a known Alzheimer’s disease (AD) patient who undergoes screening for a variant of APOE (apolipoprotein E) that a study is targeting. If the patient does not screen positive for the variant, is it advisable or is there any obligation for the study team to disclose the results or explain why the patient was ineligible to join the trial?
The best course of action will depend on many variables, such as the disease or population being studied and the genotype/phenotype relationship, risk, and impact on care. Obtaining appropriate assistance to facilitate planning up front for the complexities involved will save sponsors time and effort in the long run.
For a deep look into the best practices and considerations for including genetic testing in your clinical development strategy, read this article by our Aman Khera, Vice President, Global Head of Regulatory Strategy and Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Diseases. Topics covered include:
- Whether or not to disclose the results
- The role of principle investigators in the decision
- How to communicate with sites regarding expectations for revealing or not revealing genetic results to patients who are not enrolled in a study and for whom there may be no mechanism for follow-up
- Why unenrolled patients’ clinical trial experience matters
- Who should disclose results and how they should go about it
- What kind of assistance patients should expect from their clinical research organization.