Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials

Abstract

OBJECTIVE The US FDA uses evidence from clinical trials in its determination of safety and utility. However, these trials have often suffered from limited external validity and generalizability due to unrepresentative study populations with respect to clinical patient demographics. Section 907 of the FDA Safety and Innovation Act (FDASIA) of 2012 attempted to address this issue by mandating the reporting of certain study demographics in new device applications. However, no study has been performed on its effectiveness in the participant diversity of neurosurgical device trials. METHODS The FDA premarket approval (PMA) online database was queried for all original neurosurgical device submissions from January 1, 2006, to December 31, 2019. Endpoints of the study included racial and gender demographics of reported effectiveness trials, which were summated for each submission. Chi-square tests were performed on both endpoints for before and after years of FDASIA passage and implementation. RESULTS A total of 33 device approvals were analyzed, with 14 occurring before SIA implementation and 19 after. Most trials (96.97%) reported gender to the FDA, while 66.67% reported race and 63.64% reported ethnicity. Gender breakdown did not change significantly post-SIA (53.30% female, p = 0.884). Racial breakdown was significantly different from the 2010 US Census for all races (p < 0.001) both pre- and post-SIA. Only Native American race was significantly different in terms of representation post-SIA, increasing from 0% to 0.63% (p = 0.0187). There was no significant change in ethnicity. CONCLUSIONS The FDASIA, as currently written, does not appear to have had a significant impact on the racial or gender diversity of neurosurgical device clinical trial populations. This may be due to the noncompulsory nature of its guidance, or a lack of more stringent regulation on the composition of clinical trials themselves.

Diversity in Orthopaedic Surgery Medical Device Clinical Trials: An Analysis of the Food and Drug Administration Safety and Innovation Act

“…Although the SIA demonstrated an appreciable increase in female patient enrollment, it did not increase race or minority enrollment, nor did it improve the study's likelihood of analyzing its effect on a devices' safety or efficacy. Several analyses of orthopaedic and neurosurgery trials have demonstrated inadequate enrollment of minority patients, 9,10,15 consistent with our analysis of orthopaedic class III medical device trials. Despite the passage of the SIA, medical device trials continue to inadequately enroll minority patients.…”

“…8 Despite our understanding that patient-specific disparities exist within the heterogenous population of the United States, certain groups of patients, particularly women and minorities, have historically been excluded from clinical trials. [9][10][11] This has led to poor generalizability of outcomes research across the US population. To counteract growing disparities, President Bill Clinton signed the National Institutes of Health Revitalization Act of 1993 Public Law 103-43, which implored the National Institutes of Health to expand enrollment of women and minorities in research studies.…”

Enhancing Diversity and Inclusion in Clinical Trials

“…Limited diversity in trial populations may also further perpetuate health inequalities. [11][12][13] New medical products may not be beneficial to all people who need them, and existing inequities in health outcomes among various population groups may remain unchanged or worsen, or new disparities may arise. The inclusion of diverse populations allows investigators of clinical trials to evaluate new medical products within diverse contexts and leads to trial results that reflect the safety and efficacy of the product more completely, thereby providing patients and their providers with greater confidence in the results.…”

“…Inadequate representation of these groups may lead to an incomplete understanding of the safety and efficacy of new medical products, and limit the generalizability of trial findings. Limited diversity in trial populations may also further perpetuate health inequalities 11–13 . New medical products may not be beneficial to all people who need them, and existing inequities in health outcomes among various population groups may remain unchanged or worsen, or new disparities may arise.…”