On July 26, 2017 the International Council for Harmonization posted the announcement of the availability of the E19 Concept Paper on Optimization of Safety Data Collection. The Concept Paper proposes to provide an internationally harmonized guidance on when it would be appropriate to use a selected approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented.
Specifically, the document emphasizes that "in the later stages of drug development, when the common side effects of a drug are well-understood and documented, a more targeted approach to safety data collection may be appropriate, as long as patient welfare is not compromised. Under such circumstances, some of the data routinely collected in clinical studies may provide only limited additional knowledge. These data may include: non-serious adverse events, routine laboratory assessments, physical examinations, vital signs, and concomitant medications".
Recently, the FDA provided guidance for situations where selected data collection may be sufficient (see FDA Guidance for Industry: Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Post-approval Clinical Investigations). However, ICH says that currently, there is no widely adopted guidance available on when the use of targeted safety data collection would be appropriate in late-stage pre-marketing or post-marketing studies, or on how to implement such an approach.
Furthermore, ICH points out that they "will require experts in clinical medicine, biostatistics, pharmacy, drug safety, and regulatory science, to be nominated from the Members and Observers in line with the applicable Rules of Procedure. It is expected that consultation will be sought from patient representative(s) during development of the Guideline".
Finally, the document states that "the proposed Guideline would be consistent with risk-based approaches and quality-by-design principles".
The ICH E19 Concept Paper and Business Plan are now available for download in the Efficacy section of the ICH website.