Selective Safety Data Collection (SSDC) Demonstration Project

Selective Safety Data Collection (SSDC) offers an innovative approach to facilitate the conduct of large-scale efficacy and safety trials through the purposeful reduction in the collection of certain types of data for drugs or biologics with a well-characterized safety profile. C3TI aims to promote the adoption of SSDC principles into appropriate drug development programs. The SSDC demonstration project aims to partner with sponsors to strategically streamline data collection in some late-stage pre-approval or post-approval trials, creating benefits such as reducing the burden of collecting unnecessary safety data, eliminating unnecessary expense and allocating resources to the relevant objectives of a study, and facilitating trial conduct to answer important scientific questions on long-term efficacy and safety of drugs and biologics.

CDER partnership with sponsors to implement SSDC in appropriately identified trials will result in improved understanding of its real-world applicability, demonstration of its ability to facilitate efficient clinical trials, identification of potential challenges that programs encounter and ways to address those challenges, and promotion of best practices. This demonstration project intends to provide lessons learned from prospectively planned clinical trials integrating SSDC through close communication and collaboration among sponsors and CDER subject matter experts and review staff. Ideal studies include specific late-stage pre- or post-marketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well-understood and documented.

Benefits of participation

By participating, sponsor(s) would receive additional CDER engagement support for trial design and implementation aspects, which includes leaders across several CDER offices (e.g., Office of New Drugs, Office of Medical Policy, Office of Translational Sciences). Engagement may include access to additional coordination support with CDER subject matter experts and an inspection process that is fit-for-purpose for the innovative design (i.e., focused on a quality by design approach).

Eligibility Criteria for SSDC Demonstration Project Proposals

• The sponsor has an active pre-Investigational New Drug (IND) or IND for the product(s) included in the proposal.
• The trial must be a late-stage pre- or post-marketing trial for a drug product where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. This may include:
  • Trial for an approved drug, seeking a new indication in a similar population to that in which it was already approved
  • Trial for an approved drug, seeking to expand the label to include additional endpoints in the same patient population
  • Safety trial investigating a very specific safety concern (e.g., a PMR under FDAAA)
  • Trial designed to provide additional evidence of efficacy when current data support a well-characterized safety profile
• The sponsor and FDA are able to reach agreement on the trial design information to be publicly disclosed.
  • Sponsors participating in demonstration projects will be expected to share select details of their clinical trials and the implementation of clinical trial innovations as they progress, starting as early as the finalization of study design. This sharing may include updates, lessons learned, and relevant insights gathered during the demonstration trial. It is understood that these shared details will reflect general principles and innovative aspects, while maintaining the necessary confidentiality of proprietary or sensitive information.

Instructions on how to submit a proposal can be found on the C3TI Demonstration Program Proposal Submission webpage.

Additional Resources

• E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials Guidance
• E19 Guidance Snapshot
• E19 Guidance Podcast and transcript