FDA finalizes guidance on promoting diversity in clinical trials and solicits comment on a new Integrated Review Assessment. Meanwhile, the UK’s MHRA releases its first guidance on RWD.
IN THIS ISSUEFDA finalizes guidance on promoting diversity in clinical trials and solicits comment on a new Integrated Review Assessment. Meanwhile, the UK’s MHRA releases its first guidance on RWD. FDA, Friends of Cancer Research contemplate streamlined expedited development pathways for promising cancer drugs.
FDA finalized guidance promoting diversity in clinical trials across all therapeutic areas. This is in line with existing cancer-specific guidances encouraging sponsors to include patients with comorbidities such as organ dysfunction, HIV/HCV infection, brain metastases and more. The guidance also adopted some of the Clinical Trials Transformation Initiative (CTTI) recommendations regarding the use of RWD to recruit patients for clinical trials.
MHRA issued its first RWD-related guidance document, addressing issues on trial registration, study design, inspections and safety reporting requirements. While their initial focus is on prospective, randomized RWD studies and they don't rule out the use of such studies for new drugs, MHRA anticipates RWD's primary use will be for label expansion.
It was also announced that the UK is going to continue to accept EU MAs for 2 years post-Brexit.
FDA is accepting comments until December 30 on a new Integrated Review documentation template meant to streamline the review process and reduce redundancies in documentation. While the new template is improved in some respects, organizations, including Flatiron, have expressed concern to the FDA that valuable information, such as milestone meeting minutes in public approval documents, have been left out from public reviews.
Friends of Cancer Research (FoCR) held their annual meeting in mid-November and showcased an engaging panel discussion exploring potential changes to FDA’s programs aimed toward speeding patient access to innovative treatments.
EVENTS
Dec 15
EU Big Data Stakeholder Virtual Forum
European regulators are exploring how to leverage big data to enhance medicine development. During this meeting, stakeholders will provide their perspectives to help inform implementation of the HMA-EMA Big Data Steering Group work plan. Speakers include life sciences companies, academics, consumer groups and health care providers.