Phase II clinical trials are a crucial step in the drug repurposing process. This presentation highlights the development and utilization of Phase II clinical trial resources as an essential component of the REPO4EU platform and outlines the comprehensive tools and services offered to enhance the quality and efficiency of investigator-initiated trials.
Numerous elements required to enable high quality Phase II clinical trials will provide guidance and recommendations to academic researchers aiming to conduct trials with repurposed medicines. Relevant resources are described to enable the conduct of investigator-initiated early phase trials, adhering to Good Clinical Practice and the applicable EMA guidelines to meet all EU-required clinical trial deliverables.
The Phase II resources part of the platform serves as an online reference for conducting Phase II clinical trials by providing tools and services to help the researcher design and execute a drug repurposing trial. These tools and services include a match-making trial site registry for specialised research centers, a registry for a variety of experts required for clinical trials, ‘essentials checklist’, standard operational procedures, templates, guidance on budgeting, and trial design support.
In line with REPO4EU’s high precision and mechanism-based approach, innovative trial design options are described with the aim to increase efficiency and cost-effectiveness of drug development by requiring a lower number of patients and reducing trial costs.Trial design resources will provide examples of fit-for-purpose trial designs such as umbrella trials, basket trials, platform trials, N-of-1 trials, (Bayesian) adaptive designs.
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