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| home > epc > autumn 2004 > conducting oncology clinical studies: perils, pitfalls and practical tips |
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European Pharmaceutical Contractor
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Oncology clinical trials are complex and require a different standard of conduct than trials in many other therapeutic areas. Patient recruitment difficulties, long timelines, complex study designs (novel targeted therapies), complex data collection and the increasing use of sites in various regions of the world combine to make oncology trials particularly challenging. This article will provide practical insights to help organisations avoid common pitfalls in running oncology clinical trials.
Patient Recruitment Challenges
Oncology clinical trials have notoriously low participation rates among adult patients. According to the National Cancer Institute (NCI) in the US, only three per cent of US adults with cancer participate in clinical trials. This can be attributed to several factors, including:
Lack of Confidence in Quality of Treatment
Many patients are not willing to participate in clinical trials because of negative perceptions that the treatments are 'experimental' and therefore inferior to currently accepted treatments.
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By Mark Grose, Vice President, Program Management for Endpoint Research
Mark Grose has over 14 years' experience conducting oncology clinical trials in biotechnology, pharmaceutical and CRO environments, from traditional chemotherapeutic regimens to more complex targeted approaches. He received his BSc in 1976 from Ontario Canada's York University and joined Endpoint Research in Mississauga, Ontario, Canada, after working for nine years in academic research. He is currently Vice President, Program Management, overseeing Endpoint's project teams responsible for delivery of client clinical trials. While most of Mark's experience has been with classical Phase II and III clinical trials, recent work includes novel Phase I or I/II study designs. His experience includes conducting trials in Canada, the US and UK.
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