Iain Chalmers: Lancet 2000; 356:774
Sir-In your June 24 editorial (1) 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,(2) and reduced capacity to do studies which although of no commercial interest, are of great relevance to the needs of patients and health services.(3)
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 metaregister 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 (4) 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.(5)
lain Chalmers
UK Cochrane Centre, NHS R&D Programme, Oxford OX2 7LG, UK
1. Editorial. Safeguarding participants in clinical trials. Lancer 2000; 355: 2177.
2. Soares K, McGrath J, Adams C. Evidence and tardive dyskinesia. Lancet 1996; 347: 1696-97.
3. Warlow C, Sandercock P, Dennis M, Wardlaw J. Research funding. Lancet 1999; 353: 1626.
4 Kitzinger S. The new good birth guide. Harmondsworth: Penguin, 1983.
5. Sykes R. Being a modem pharmaceutical company: involves making information available on clinical trial programmes. BMJ 1998;317:1172.