A guide to patient-led good controlled trials

Abstract

In your June 24 editorial1Editorial. Safeguarding participants in clinical trials.Lancet. 2000; 355: 2177Summary Full Text Full Text PDF PubMed Scopus (15) Google Scholar you note that industry is increasingly using questionable methods to persuade investigators and patients to help it pursue commercial agendas. Such alliances undoubtedly sometimes result in shareholders and patients being better off; they are also one of the most powerful distorting influences on a clinical research agenda which is already failing to meet many of the needs of consumers of research. The costs to the public of this distorted agenda are an outpouring of studies addressing trivial questions,2Soares K McGrath J Adams C Evidence and tardive dyskinesia.Lancet. 1996; 347: 1696-1697Abstract PubMed Google Scholar and reduced capacity to do studies which, although of no commercial interest, are of great relevance to the needs of patients and health services.3Warlow C Sandercock P Dennis M Wardlaw J Research funding.Lancet. 1999; 353: 1626Summary Full Text Full Text PDF Scopus (2) Google Scholar Among the various actors in this scenario, patients are likely to have the most unconflicted vested interests in promoting important trials. Recognising this, some consumer groups are working in partnership with researchers to promote participation in trials. For example, Action on Pre-eclampsia—a consumer group—is one of the partners promoting research to assess the effects of magnesium sulphate on severe pre-eclampsia, a potentially useful treatment, of no commercial interest. Now that an international meta-register of controlled trials has been established (www.controlled-trials.org accessed, Aug 9, 2000), the framework exists for creating a consumer-led, electronic good controlled trials guide, to help people who are considering participating in trials to make well-informed choices. Consumer commentaries on trials in the register could cover, for example, the importance of the questions being addressed, whether these had already been answered satisfactorily by previous research, whether the design of the study was scientifically and ethically robust, whether the primary outcomes chosen mattered to patients, and whether arrangements were in place for communicating the results of the research to those who had participated in it. Mobilisation of consumer influence in this way might help to reorientate the clinical research agenda to serve the interests of patients better, just as Sheila Kitzinger's good birth guide,4Kitzinger S The new good birth guide. Penguin, Harmondsworth1983Google Scholar for example, helped to make British maternity hospitals more aware of the public image of the care each of them was providing. Researchers and research sponsors will need to realise that one of the preconditions for consumer endorsement of and partnership in their trials is likely to be that protocols and other trial documents should be made public. Researchers—commercial or non-commercial—who wish to compete successfully for the attention of potential partners must therefore be prepared to be far more open about their activities than they have been in the past.5Sykes R Being a modern pharmaceutical company: involves making information available on clinical trial programmes.BMJ. 1998; 317: 1172Crossref PubMed Scopus (46) Google Scholar