Co-creation with patients is vital for effective clinical trial design. A study by Skovlund, PC, Nielsen, BK, Thaysen, HV et al. shows that, in clinical trials, “patient involvement can lead to improvements in design, selection of relevant outcome measures and effective recruitment of trial participants”. For a medicine to be authorised, clinical efficacy and safety need to be established, usually through robust and relevant clinical trial data. There are several unique challenges in the development of orphan disease treatments. Low patient numbers, an incomplete understanding of the disease pathology, phenotypic heterogeneity and a lack of established endpoints are barriers to efficient and effective clinical trials. A key aspect is the choice and selection of the primary and key secondary efficacy endpoints: a reliable, valid, sensitive, interpretable and meaningful endpoint is vital to a well-designed study. This is necessary both as the basis to demonstrate the clinical impact of any therapeutic intervention and to stand up to regulatory scrutiny.

In this webinar, attendees will learn how Aparito’s Patient Group Accelerator Programme enables patients to co-create alongside sponsors & CROs. The Accelerator is designed to understand and fulfil patients’ needs by working closely with patient organisations and finding new endpoints that are relevant to their specific conditions. The featured speakers speak to a young patient to gain their perspective on being involved with clinical trial design and they demonstrate how this feedback can be taken into study design as they close out the session with a real-life example from Aparito’s Accelerator programme.

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Clinical Healthcare

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