Author + information
Historically, women and minorities have been underrepresented in clinical trials of drugs to treat cardiovascular disease (CVD). To accurately assess the safety and efficacy of CVD drugs, the U.S. Food and Drug Administration (FDA) has made a conscious effort to ensure adequate representation of women and minorities in clinical drug trials through guidance documents and regulations. The purpose of this study is to assess the participation of women and racial/ethnic minorities in FDA-reviewed CVD drug trials that were included in New Drug Applications (NDAs) approved between 2010 and 2011.
The sex and race/ethnicity of subjects in all CVD drug clinical trials submitted to FDA in support of NDAs approved between January 2010 and December 2011 were assessed from final clinical study reports. The reports were accessed via internal FDA databases.
Four drugs (1 per NDA) indicated for hypertension (HTN), acute coronary syndrome (ACS), non-valvular atrial fibrillation (NAF) and deep vein thrombosis/pulmonary embolism (DVT/PE) after joint replacement surgery were approved during the period studied. A total of 231 clinical trials classified as phase 1, 2, or 3 studies were submitted to the NDAs. There were 107,156 subjects included in these studies. Demographic analysis (shown in Table 1) indicated that the mean participation of women in these trials was 41% and the majority of the trial subjects were Caucasians (79%). When analyzed by the phase of the trials, mean female participation was 21%, 43% and 42% for Phase 1, 2 and 3 respectively.
The overall inclusion of women in these CVD drug trials is comparable to the overall female CVD population (51%) in the US. However, women are largely underrepresented in the Phase 1 trials, during which much of the pharmacokinetics and pharmacodynamics of new drugs are evaluated.
- 2013 American College of Cardiology Foundation