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Conducting Non-commercial Clinical Trials Internationally - Experiences of a UK based Academic Clinical Trials Unit

Primary: Claire F. Snowdon
Author(s): Claire F. Snowdon Lisa Fox Sarah Kernaghan Christy Toms Judith Bliss
The Institute of Cancer Research The Institute of Cancer Research The Institute of Cancer Research The Institute of Cancer Research The Institute of Cancer Research

SCT Annual Meeting 2018

Background Academic clinical trials play a fundamental role in the development of new treatments, the repurposing of existing treatments and in addressing areas of unmet clinical need. With cancer treatments increasingly targeted at molecular sub-types, and with priority placed on developing new treatments for rare tumour types, the need for international trial participation to access sufficient patient numbers for successful trial conduct is growing. However, lack of harmonisation of international legal, ethical and financial systems can make this challenging and the cost and effort of conducting trials internationally can be considered prohibitive, particularly where the sample size is comparatively small. Methods The Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU) is a UK based academic clinical trials unit that specialises in the design, conduct and analysis of clinical trials of cancer treatments with an expanding portfolio of trials in molecular subtypes of breast and urological cancers and in other rare cancer types. Implementing appropriate mechanisms to enable international participation has therefore been imperative. Here we explain how we have approached the challenges involved and describe examples of successful international trial conduct, achieved through robust collaborations between academic and industry partners. Results The CASPS trial of cediranib in patients with alveolar soft part sarcoma (ISRCTN63733470) closed to recruitment in July 2016, after reaching the required sample size of just 48 patients over a period of 5 years. Alveolar soft part sarcoma is rare, with an estimated incidence of only 15 cases per year in the UK. International participation in this trial was therefore imperative and has been a result of extensive, numerous and complex collaborations. To deliver the CASPS trial we received funding, support and advice from a UK cancer charity, the pharmaceutical company partner, a drug distribution company, international academic groups, their respective trials units and CROs, insurance brokers, contracts teams and lawyers. Conclusions Conducting international trials can be challenging for academic sponsors but can be achieved through appropriate governance arrangements, funding mechanisms and strong collaborations with international collaborative trials groups, and industry where applicable. CASPS is an excellent example of how such collaborations have helped to deliver an academic trial internationally. In trials of rare cancers where the sample size is comparatively small, although the required investment can seem disproportionate and difficult to justify, it is essential if progress is to be made in these areas of unmet clinical need.

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