CHCUK News & Articles

Draft FDA Guidance – Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics

This draft FDA guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. FDA...

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Which Real-World Research Design Is Best?: An Algorithmic Approach to Optimal Study Design for Outcomes Research

In contrast to clinical development, in which the randomized controlled trial (RCT) is the go-to study design, real-world research encompasses a broader array of designs from which to choose. There are retrospective approaches, including database analysis and manual...

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Compilation of Guidances on the EU GDPR

The US Office for Human Research Protections (OHRP) has compiled a very useful list of the country-by-country guidelines and supporting information on the impact of the EU General Data Protection Regulation (GDPR) If you are new to the General Data...

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