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. Modifying private and government health insurance regulations that may inhibit participation in clinical trials is another goal.
Armin Weinberg, the leader of the study, said that results of trials would be better if they enrolled participants who were more representative of the patient population.
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, more importantly, from the point of view of the industry and some patients’ groups, delay the introduction of new drugs to the marketplace. Presently many of these questions are answered in phase IV trials conducted after a drug is approved.
Ken Johnson, senior vice president for Pharmaceutical Research and Manufacturers of America, agreed that the recommendations could slow the introduction of new treatments. “Recruitment of patients for clinical trials can be challenging and, when slow moving, can potentially slow the research and development process,” he said.
He acknowledged the need to answer such questions in different groups of people but added: “It is also important that the thoroughness of research is balanced with the need to bring potentially life changing new medicines to the patients who need them.”
One of the more controversial recommendations is that the FDA should set inclusion standards for a trial, imposing penalties for non-compliance and awarding incentives when those goals are met. That is likely to require legislation expanding the FDA’s authority.
The $5.5m (£2.8m; €3.5m) four year project is supported by an unrestricted educational grant from the biotechnology company Genentech and grants from the National Institutes of Health’s offices of minority and women’s health.
Information on EDICT is available at www.bcm.edu/edict.