Industry-funded research has long been criticised for its ability to allow bias through the manipulation of the reporting of results. This paper describes an approach that addresses some of these concerns by implementing a process for the conduct of clinical trials, especially trials conducted in private practice. The approach involves the use of a private practice clinician to act as chief investigator to design a study, recruit fellow investigators, employ a contract research organisation (CRO), organise insurance and to act as the designated sponsor of the project, thereby relegating ownership of the study data to the investigators, as sponsors, rather than the pharmaceutical company funding the trial. All parties involved must adhere to Good Clinical Practice (GCP) standards. In an ongoing trial using this model, the chief investigators adopted the role of sponsor but separated the management and finances of the trial from the other accounting procedures within the clinical practice by using the vehicle of a pre-existing, limited liability, registered private company which already undertook such activities with regards to clinical research conducted within the private practice setting. The study was a multicentre, placebo-controlled, double-blind, randomised, crossover design. Operating procedures were designed to overcome any potential areas of conflict of interest. A CRO was contracted to manage the day-to-day conduct of the trial. The sponsoring company, representing the investigators, was completely independent of the funding pharmaceutical company thereby ensuring unencumbered potential to publish findings, irrespective of their positive or negative results. The concept in which a pharmaceutical company funds, but does not sponsor, a trial ensures that the execution, ownership and reporting of the study findings remain the precinct of the sponsor, which is independent of commercial influences relevant to the pharmaceutical industry. Such autonomy, granted to the chief investigators, may provide a significant advance in the realisation of clinical drug trials, especially those conducted within community based private practice, and respects scientific integrity without sacrificing mandatory rigour. © 2005 Adis Data Information BV. All rights reserved.
