September 20, 2016
On Friday, September 9th, the FDA announced the availability of a draft guidance entitled “E17 General Principles for Planning and Design of Multi-Regional Clinical Trials.” The draft guidance, which was developed by the International Council for Harmonisation (ICH), was issued in June of this year and is intended to help sponsors with the planning and design of multi-regional clinical trials (MRCTs), as well as facilitate more efficient drug development and provide earlier access to medicines.
The recommendations included in the draft guidance apply mainly to drugs and biological products, but could also be applied to studies involving other types of treatments. Furthermore, the document states that its primary focus is “on MRCTs designed to provide data that will be submitted to multiple regulatory authorities for drug approval (including approval of additional indications, new formulations and new dosing regimens) and for studies conducted to satisfy post-marketing requirements.”
According to the draft guidance, an MRCT is “a clinical trial conducted in more than one region under a single protocol.” Typically, MRCTs are the preferred option when sponsors are planning to submit a drug to various regulatory agencies in multiple regions. “The underlying assumption of the conduct of MRCTs is that the treatment effect is clinically meaningful and relevant to all regions being studied.”
In the past, many drug development programs were focused on specific regulatory regions, only making use of MRCTs when either the disease or condition was rare or when very large numbers of subjects were required. However, recently we have seen an increase in the number of global regulatory strategies being used. The reason for this shift? Although more planning and coordination is involved, MRCTs and global regulatory strategies increase trial efficiency and help to facilitate more rapid drug development and availability. In addition, MRCTs provide sponsors with the following benefits:
The draft guidance provides a number of requirements and considerations that should be considered by sponsors when conducting MRTCs. These include, but are not limited to:
Interested in learning more about FDA’s draft guidance? Stay tuned… Part two is coming soon with details on clinical trial design and protocol-related issues.
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