Goals of Clinical Trials
Society wants trials that will advance the cause of evidence-based medicine, improve the quality and effectiveness of care, and correct errors in past practice. Desired trial goals are to save money for the health care system, to identify what does not work, and to be a force for cost containment. While clinical trials should be robust and efficient and timely and accessible, they should also honor a lengthening list of social criteria and priorities: diversity of the study populations, meticulous patient safety, strict informed consent, rigorous institutional review, and, not least important, accountability with respect to investigators’ conflicts of interest and the role of industry and private interests in sponsoring and shaping the trials.
Although it obviously would require heavier investment in clinical trials in order to achieve all these goals, Brown said, it is not so clear where that money should come from. Should it derive from new public money at a time when government budgets are under intense pressure? Should it be public money rechanneled from basic research to clinical evaluations? Should it be private money? Should institutions bear more of the costs of running trials? Should it come from a combination of these sources?
In part because of multiple goals, competing internal priorities, and funding uncertainties, over time researchers have not only increased the number of trials but also asked more of them, by making them more complex, and, in some ways, more internally conflicting. Researchers have complicated the design and execution of trials—essentially for political reasons—because trials stand at the center of converging, yet often incompatible, public and professional priorities and expectations.
The NIH Example
Managing the kinds of conflicts and tensions faced by trial researchers ought to be possible. Indeed, the lustrous history of biomedical research in the United States since the end of the Second World War, primarily under the auspices of NIH, suggests that is so.
NIH has developed an impressive list of political resources and strategies that might offer clues and cues for managing the current clinical trials enterprise. Brown provided a checklist of these NIH resources and strategies, along with some of the notable individuals involved, including the following:
• Strong entrepreneurial energies by citizen advocates of great skill and tenacity, such as Mary Lasker, known for her unflagging support of biomedical research, especially cancer research,