Trial participants need to be more representative of patients

A new report is calling for changes in the conduct of clinical trials in the United States to reduce disparities of age, sex, race, and comorbidity.The goal is to give a more representative picture of the benefits and risks of a treatment across the entire population but particularly among those who bear the greatest burden of the morbidity.The eliminating disparities in clinical trials (EDICT) initiative was conducted over two years by the Baylor College of Medicine in Houston and the Intercultural Cancer Council.It is part of an ongoing four year project to reduce barriers to participation in trials.The report of the initiative was released on 1 April in Washington, DC.The report describes itself as a "nationwide call to action . . .that removes the barriers to clinical trial participation and advances education and information sharing as a critical step to improving the health status of all Americans."Recommendations include harmonising the Food and Drug Administration's regulations on trial design and conduct with those of the National Institutes of Health requiring diversity; increasing collaboration between government and industry in trials; and fostering community involvement in all phases of trial design and implementation.It calls on journals to require researchers to include an analysis of how their trial participants match the population that bears the greatest burden of that condition.It also seeks better education of institutional review boards on their ethical responsibilities and of the general public about the trials process.Calls for better education of review boards and the public are likely to draw little opposition.But other recommendations are likely to require an increase in the size of a trial to provide sufficient numbers for subgroup analysis according to sex, race, age, and comorbidity.This will increase the cost of trials and could delay the introduction of new drugs to the marketplace.Information on EDICT is available at www.bcm.edu/edict. Trial participants need to represent patients betterUK NEWS Wakefield tells GMC he was motivated by concern for autistic children, p 738 World NEWS Australian drug firms give details of sums spent courting doctors, p 742 bmj.com reducing inequalities in health will need a long timeframe, MPs are told