Phase III Clinical Trials
Team leaders: Prof. Rob Coleman & Prof Penella Woll
Summary
The development of the North Trent Cancer Research Network has considerably increased clinical trials participation across a broad range of solid tumours. Between 10 and 17% of all cancer patients in the North Trent network have been entered into clinical trials over each of the past three years, the majority of these into national and international phase III studies.
Background
Developments in cancer care rely on the evidence generated from clinical trial participation, typically the randomised controlled trial. Trial participation has many benefits for cancer patients. The opportunity to receive new potentially more effective treatments is an obvious advantage, but equally important is the detailed special monitoring and close medical and nursing supervision that comes with participation in a trial. These latter aspects have been shown in themselves to improve the outcome and survival of cancer patients over and above those not treated within a clinical trial. The importance of clinical trials has been appreciated by the cancer charities for many years. Recently, the NHS has made efforts to improve clinical trial participation and establish inclusion within a cancer trial as the standard of care. Specific funds to support research infrastructure across cancer networks were identified and these have more than doubled the numbers of patient recruited into clinical trials considered to be of national importance.
All trials are peer reviewed, discussed at the Clinical Trials Executive to assess priority and complexity, presented to the Clinical Developments Group to identify resource and staffing implications for the hospital alongside the ethical review process and the various stages of approval required to comply with the research governance requirements of the Trust.
Over the last 10-15 years many thousands of our patients have taken part in large multicentre phase III trials. This in itself is a considerable achievement but when one considers the long term follow-up required for many of the patients in these studies and the complexity of information required to satisfy the regulatory authorities, research governance requirements and more recently the demands of the European Directive on clinical trials, it is clear that high levels of expertise, co-ordination and organisation are required to provide meaningful and publishable data.