Multi-Regional Clinical Trials: ICH and FDA General Principles for Planning and Design
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Multi-Regional Clinical Trials: ICH and FDA General Principles for Planning and Design
With the increasing globalization of drug development, the use of multi-regional clinical trials (MRCTs) for regulatory submissions has increased. Regulatory authorities in different countries such as Japan, USA, EU and China have issued the guidance documents on MRCTs. ICH has started the process for having a harmonized guidance document on MRCTs and the document is likely to be issued in 2017.
In line with this, the US FDA has issued the draft guidance on MRCTs in September 2016. This guidance document defines the general principles for the planning and designing of multi-regional clinical trials. The guidance is proposed to aid sponsors conducting MRCTs while reducing unnecessary duplication.
Key Focus Areas
The guidance provides the recommendations for the design and planning of the MRCTs. Some of the key areas covered in the guidance include:
- Strategy related Issues
- Value of MRCT in drug development
- Basic requirements and key considerations
- Scientific consultation meetings with regulatory authorities
- Clinical trial design and protocol related issues
- Pre-consideration of regional variability and its potential impact on efficacy and safety
- Subject selection
- Selection of doses for use in confirmatory MRCTs
- Choice of endpoints
- Estimation of an overall sample size and allocation to regions
- Collecting and handling of efficacy and safety information
- Statistical analysis planning to address specific features of MTCTs
- Selection of comparators
- Handling concomitant medications
This guidance has addressed these areas and many more to ensure clarity in adhering to the regulatory requirements.
Click here to download the file
