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ESMO Responds to WHO Consultation on Guidance for Global Practices for Clinical Trials

26 Sep 2023

ESMO’s response to the draft World Health Organization (WHO) guidance for global practices for clinical trials highlights that successful development of clinical research requires patient-centredness. ESMO’s response further stresses that clinical trial implementation guidance should address a variety of issues, such as how to promote diversity and inclusiveness, and remove geographic barriers to patient access to clinical trials. Practical guidance on addressing complexities of clinical trial design, especially in rare molecular subsets of tumours, and selection of endpoints is also necessary. The response follows ESMO’s continuous input to WHO efforts to strengthen clinical trials globally.

A critical issue for clinical trials that requires addressing is regulatory hurdles; a timely example is the implementation of European Union’s (EU) Regulation on In Vitro Diagnostic Medical Devices (IVDR) on patient access to clinical trials utilising in-vitro diagnostics, which has resulted in fragmented initiation processes for clinical trials, including those conducted in the oncology space. As such, ESMO recommends developing streamlined global regulatory frameworks for clinical trials and ensuring the long-term sustainability of strengthened clinical trial ecosystem. Global practices for clinical trials should also strive for effective global data sharing, and independent academic clinical research should be supported and funded.

The WHO consultation stems from the Seventy-fifth World Health Assembly resolution on ‘Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination’, in which the 194 Member States requested the WHO to develop guidance on best practices for clinical trials.

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