Clinical trials are a critical source of information for investigational products, but also provide useful data to direct policy development and practice. Effective and pertinent regulatory oversight is necessary to ensure that patients are protected and resulting data has integrity.
The FDA has noted its current “effort to modernize the regulatory framework that governs clinical trials and approaches to good clinical practice.” As a medical device CRO, we’ve seen this endeavor in action with the development of guidance documents like Electronic Source Documentation in Clinical Investigations, and A Risk-Based Approach to Monitoring.
According to a recent news-release, the FDA is holding a public hearing on how to best modernize the regulations, policies and practices that apply to clinical research. The news-release notes the purpose of the meeting is obtain input from IRBs, CROs, investigators, sponsors, and patient groups to facilitate advances and remove impediments in clinical trials.
The topics prepared for discussion include:
- What efforts could FDA consider that might help mitigate some of the challenges resulting from increased clinical trial complexity and globalization?
- What are some innovative methods or models that facilitate building quality into the conduct of trials?
- What are the specific stakeholder challenges presented by FDA's GCP regulations, policies, and/or practices to building quality into the clinical trial process?
- How should FDA focus its efforts in GCP regulations, policies, or practices while maintaining the protection of research participants and the quality and integrity of data supporting regulatory decision-making?
- What additional efforts should FDA pursue to modernize the Agency's GCP regulations, policies, and practices?
Do the regulations need to be modernized? If you were to attend this public hearing, what would your answers be to the questions above?