Conducting non-commercial international clinical trials: the ICR-CTSU experience.
View/ Open
Date
2017-09-26Author
Fox, L
Toms, C
Kernaghan, S
Snowdon, C
Bliss, JM
Type
Journal Article
Metadata
Show full item recordAbstract
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 subtypes, 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. In this article, we explain how we have approached the challenges involved and describe examples of successful international trial conduct, achieved through robust collaborations with academic and industry partners. CONCLUSION: Conducting academic trials internationally is challenging but can and should be achieved through appropriate governance mechanisms and strong collaborations.
Collections
Subject
Humans
Neoplasms
Antineoplastic Agents
Treatment Outcome
Research Design
International Cooperation
Drug Costs
Policy Making
Clinical Trials as Topic
Research Support as Topic
Multicenter Studies as Topic
Public-Private Sector Partnerships
Research team
Clinical Trials & Statistics Unit
Language
eng
Date accepted
2017-09-11
License start date
2017-09-26
Citation
Trials, 2017, 18 (1), pp. 440 - ?
Publisher
BMC