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Eliminating the “expensive” adjective for clinical trials

2013; Elsevier BV; Volume: 167; Issue: 4 Linguagem: Inglês

10.1016/j.ahj.2013.12.003

1097-6744

Michael S. Lauer, Denise E. Bonds,

Clinical practice guidelines implementation

In the TV game show Family Feud contestants are asked to fill in the blank for sentences or phrases, with the “right answers” coming from previously completed surveys. Some entries are easy, like “Don’t judge a book by its ____.” Others are less so, like “Prime ____.” If there were a medical version of Family Feud, an easy question, at least in contemporary times, would likely be “Expensive Clinical _____.” A more difficult, if not impossible, one would be “R____ R____ Trial.”What two juxtaposed “R words” would make sense? Many have predicted the demise of the clinical trial. “Too expensive! Too limited in population, outcomes and intervention! Results are not generalizable to my patients.” However, even the naysayers agree that clinical trials yield the highest quality medical evidence. Practice guidelines cite results of large-scale clinical trials and well-conducted clinical trials can diametrically change medical practice. Arguably, it would be better to change the way we conduct clinical trials than to discard the methodology. If we can make clinical trials cheaper, quicker, and relevant to more patients, they will continue to provide high quality evidence. To get there, we will need to do research on the way we do research. In the spirit of doing research on research, NHLBI officials recently took a hard look at the Institute’s clinical trial portfolio. Among 244 trials funded over a decade, less than 20% focused on clinical events. Yet those handful of trials accounted for over 80% of the citations and were published many times faster; indeed many of the small-sized surrogate endpoint trials were never published or only after a long delay. Commentators argued that these findings should offer impetus to funders to change their priorities, shifting focus towards large simple trials that focus on clinical endpoints. Meanwhile, some clinical investigators have begun to experiment with radically new methods with some success, as at least 3 recent high profile trials have utilized increasingly novel approaches of leveraging existing digital platforms to conduct high-impact, low-