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

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

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...

EMA: General Principles for Baseline Categorisation of Older Patients Enrolled in Clinical Trials

EMA Public Consultation on – ‘Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations’ Start of public consultation: 21 December 2015 Deadline for comments: 31 May 2016 Provide comments using...