Regulatory Roundup: EMA Hosts Subgroup Analysis Workshop

The EMA brought together European and US expert representatives from regulatory authorities, academia, industry, and a health-technology-assessment agency on Nov. 18, 2011 to discuss the use and importance of subgroup analysis in the assessment of clinical trials. The workshop, the first of its kind, aimed to present the scope and content of a proposed guideline on the topic being prepared by the Committee for Medicinal Products for Human Use (CHMP) and garner feedback on standards and methodology.

The main conclusions drawn from the meeting about the design of trials were that as clinical trial populations are frequently heterogeneous, regulators must examine the risk–benefit balance for subsets of patients that fall outside of traditional demographics (e.g., gender, age, and ethnicity). Therefore, according to the press release, “plans to explore benefits and risks in biologically defined and potentially clinically relevant subgroups should be incorporated into every development program.” The group also agreed that early dialogue between industry and regulators about the most important subgroups to be accounted for was highly valuable and will guide assessment.

In other EMA news, registrations for the eSubmission Gateway pilot, which begins Jan. 9, 2012, are being invited. The three-month trial sees a new electronic submission channel being put into action for centralized marketing authorizations for human medicines, including new applications, supplementary information, variations, and renewals. The gateway will use a secure business-to-business transfer process, which should improve the speed and efficiency of the application process. A web-based submission client is also under development to handle low-transmission volumes that may be more suitable for small- and medium-sized companies; plans will be announced in the first quarter of 2012. Following successful completion of the pilot, which is open to a limited number of applicants, the EMA will consider extending the use of the Gateway to all applicants.