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      Phase II Clinical Trial Resources

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      conference-abstract
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      RExPO24 Conference
      REPO4EU
      RExPO24
      3-5 July 2024
      Clinical trials, Phase II, Repurposing, GCP ICH, Trial tools, Legislation, Innovative trial designs
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            Abstract

            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.

            Content

            Author and article information

            Conference
            RExPO24 Conference
            REPO4EU
            8 May 2024
            Affiliations
            [1 ] 3D-PharmXchange;
            Author notes
            Author information
            https://orcid.org/0009-0000-3034-956X
            https://orcid.org/0009-0004-2831-2038
            Article
            10.58647/REXPO.24000055.v1
            32974aa0-ab5d-4224-a444-8ac89c8d4781

            This work has been published open access under Creative Commons Attribution License CC BY 4.0 , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Conditions, terms of use and publishing policy can be found at www.scienceopen.com .

            RExPO24
            3
            Munich, Germany
            3-5 July 2024
            History
            : 6 May 2024
            Categories

            Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
            Medicine
            Clinical trials,Phase II,Repurposing,GCP ICH,Trial tools,Legislation,Innovative trial designs

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