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Mark A. Yarborough, PhD, of the Bioethics Program, University of California Davis, has called for patients to see participating in clinical trials as a "civic" duty, proposing “coordinated campaigns to cultivate civic attitudes” about trials.

By Ben Steele on May 3, 2013

The calls come amid concerns within the research community that many clinical trials are failing to meet their enrolment goals. Yarborough made his comments during a recent interview, published in the latest issue of Mayo Clinical Proceedings.

“Although there is an astonishing array of research currently under way that holds great promise to stimulate important clinical breakthroughs, not all research has the capacity to improve clinical care.” Yarborough cites trials for ‘me-too’ drugs that offer no social value as having the potential to damage the reputation of clinical research as a whole, and suggests that in order to avoid all trials being tarred with the same brush, there should be a move towards an ‘informed consent’ model. This would involve a declaration on consent forms “that states whether a trial is investigating a way to potentially eventually improve current medical care and explains why it does or does not have the potential to do so.” Yarborough writes that “Our current surrogate markers for the social worth of drugs—government approval and marketability to prescribing physicians—at times miss this most basic mark. A social value reporting system would address this deficiency.”

However, Yarborough acknowledges there are some flaws within the proposed system – the main one being the patients themselves, who may not pay much attention to the information disclosed. The system would also be unlikely to deter sponsors from conducting unnecessary clinical trials.

In the same issue Barbara Koenig PhD, of the Institute for Health & Aging, University of California, San Francisco, notes that Yarborough’s focus on the informed consent process is too limited an approach to reforming clinical trials.

She writes that “it seems odd to pin the burden on patient choice, rather than placing the responsibility for such judgments on scientific or clinical review boards,” going to on ask “rather than disclosing the potential social value of research to participants, why not change the rules and require institutional review boards to start their review with that question?” Finally, Koenig concludes by stressing the need to involve the patient before the trial is even designed: “for such a reform to be successful, we would need to devote as much time and energy to engaging with communities of patients to establish collective priorities for research as we have in writing and rewriting consent forms.”