Scientific Publications by FDA Staff

Am Heart J 2015 Mar;169(3):305-14

Improving cardiovascular clinical trials conduct in the United States: Recommendation from clinicians, researchers, sponsors, and regulators.

Butler J, Fonarow GC, O'Connor C, Adams K, Bonow RO, Cody RJ, Collins SP, Dunnmon P, Dinh W, Fiuzat M, Georgiopoulou VV, Grant S, Kim SY, Kupfer S, Lefkowitz M, Mentz RJ, Misselwitz F, Pitt B, Roessig L, Schelbert E, Shah M, Solomon S, Stockbridge N, Yancy C, Gheorghiade M

Advances in medical therapies leading to improved patient outcomes are in large part related to successful conduct of clinical trials that offer critical information regarding the efficacy and safety of novel interventions. The conduct of clinical trials in the United States, however, continues to face increasing challenges with recruitment and retention. These trends are paralleled by an increasing shift toward more multinational trials where most participants are enrolled in countries outside the United States, bringing into question the generalizability of the results to the American population. This manuscript presents the perspectives and recommendations from clinicians, researchers, sponsors, and regulators who attended a meeting facilitated by the Food and Drug Administration to improve upon the current clinical trial trends in the United States.