Drug development continues to be an increasingly global affair, and this new guidance, which was endorsed by the ICH Steering Committee in June, will help countries reconcile their general principles on planning and designing Multi-Regional Clinical Trials (MRCT).
“International harmonisation on this topic will promote to conduct MRCTs more appropriately and increase an efficiency of drug development, resulting in avoiding duplicative works in drug development and a better regulatory decision,” the ICH says.
Regulatory agencies are also “facing some challenges in evaluating data from MRCTs for drug approval,” according to the ICH, and it was “deemed necessary” to develop a harmonised international guideline to promote conducting MRCT appropriately, especially focusing on scientific issues in planning/designing MRCTs.
The guidance will specifically focus on the planning of MRCTs, particularly in terms of the usefulness of MRCTs in drug development, the importance of ethnic factors in evaluating drug efficacy/safety in MRCTs, points to consider in dose determination, how to control various concomitant medications in each country, considerations on the definition of a population and methods of sample size estimation for a population/region, and encouraging a parallel scientific consultation with multiple regulatory agencies in advance.
A lack of harmonisation on this topic may cause additional burden for sponsors and difficult situations for conducting MRCTs, the ICH noted.
FDA Moves
As the ICH says it considers the importance of ethnic factors in clinical trials, the US FDA also announced on Friday that it would take a closer look at the inclusion of safety and effectiveness data by demographic subgroups is included in medical product applications.
FDA Commissioner Margaret Hamburg announced the release of the agency’s action plan and three overarching themes: Quality, participation and transparency.
Specifically, the FDA is planning to begin drafting a guidance document on analysis and reporting of ethnicity, race and age in medical device clinical studies. The agency plans to explore key barriers and limitations to meaningful data analysis.
FDA offices also plan to revise the guidance on the Integrated Summary of Effectiveness (ISE) sections of new drug applications (NDA), and biologics license applications (BLA), “with particular attention to the importance of demographic and other subgroup analyses.”
In addition, FDA plans “to work, to the extent possible, towards better standardization of data collection categories for age, racial and ethnic groups in submitted applications to facilitate harmonized data collection and analysis of subgroup outcome trends.”