Trials and tribulations: Thoughts on the organisation of multicentre clinical studies

Abstract

The Cancer Research Campaign Trial concerning the management of early breast cancer recruited well over 2000 patients, thus making it the largest prospective study of the management of cancer on record. The management of such large numbers created specific problems of organisation. It is recommended that the protocol design and proforma should be kept simple. A centralised secretariat should be set up, and statisticians and computer programmers must be concerned at every step, including design and analysis. Large clinical trials are very expensive and should not be embarked on without adequate long-term finance. © 1980, British Medical Journal Publishing Group. All rights reserved.