TY - JOUR
T1 - Gender, racial, and ethnic disclosure in nih k-award funded diabetes and obesity clinical trials
AU - Guevara, Carlos
AU - Cook, Chad
AU - Herback, Natalie
AU - Pietrobon, Ricardo
AU - Jacobs, Danny O.
AU - Vail, Thomas Parker
N1 - Funding Information:
Keywords: NIH Revitalization Act, minority, gender, obesity, diabetes, K grant
Funding Information:
The primary objective of our study was to evaluate how the Revitalization Act has influenced the recruitment of minority and female subjects in studies funded through the NIH’s new investigator (K-grant) program. K grants, which are initiatives designed to stimulate a future research career, were selected to further streamline potential selections and to investigate the adherence of this specific group of researchers to the 1993 Revitalization Act. Our primary objective endeavored to examine the trend of both women and minority inclusion (confirmed through disclosure) in clinical trials at three timelines relevant to the implementation of the Revitalization Act (1989–1993, pre-mandate; 1993–1996, post-mandate, and 1997–present, well past mandate). Because a myriad of K grants are awarded, we focused on type II diabetes mellitus and/or obesity trials funded by either the National Institute on Aging (NIA) or National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) during 1989–2004. We specifically chose those two conditions since they are known to be more prevalent in the African American and Hispanic populations, especially diabetes mellitus, which is projected to increase 149% among Hispanics and 118% among African Americans by 2050 (Kirk et al., 2005). We hypothesized that the 1993 Revitalization Act would not only increase the recruitment of females and minorities but would also demonstrate an overall upward trend in the recruitment of these groups.
PY - 2006
Y1 - 2006
N2 - In 1993, the National Institutes of Health (NIH) passed The Revitalization Act (Subtitle B) which mandated that all NIH funded clinical trials have "appropriate representation" of minority and women subjects. Our aim was to evaluate the impact of the mandate by examining the reporting and inclusion of minority and female subjects into NIH K-Award funded clinical trials, addressing the minority predominant diagnoses of diabetes and clinical obesity. Using the CRISP search engine and PUBMED, we selected publications published by the National Institute on Aging (NIA) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) K-grant recipients during 1989-2004, associated with all the diabetes and obesity clinical trials. Studies were stratified into three timeline categories (1989-1993, pre-mandate; 1993-1996, postmandate, and 1997-present, well past mandate) to evaluate trends in the recruiting of minorities and women before, during, and after the passing of the Revitalization Act. Of the 165 papers, only 37% disclosed race, a number that did not improve over time (p=.15), whereas 92% disclosed gender. Clinical trials that focused on females increased across the 3 timeframes (p < .001) for diabetes studies but not obesity studies. Overall, disclosure of race declined over the 3 timeframes whereas individually, the disclosure of African Americans improved.
AB - In 1993, the National Institutes of Health (NIH) passed The Revitalization Act (Subtitle B) which mandated that all NIH funded clinical trials have "appropriate representation" of minority and women subjects. Our aim was to evaluate the impact of the mandate by examining the reporting and inclusion of minority and female subjects into NIH K-Award funded clinical trials, addressing the minority predominant diagnoses of diabetes and clinical obesity. Using the CRISP search engine and PUBMED, we selected publications published by the National Institute on Aging (NIA) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) K-grant recipients during 1989-2004, associated with all the diabetes and obesity clinical trials. Studies were stratified into three timeline categories (1989-1993, pre-mandate; 1993-1996, postmandate, and 1997-present, well past mandate) to evaluate trends in the recruiting of minorities and women before, during, and after the passing of the Revitalization Act. Of the 165 papers, only 37% disclosed race, a number that did not improve over time (p=.15), whereas 92% disclosed gender. Clinical trials that focused on females increased across the 3 timeframes (p < .001) for diabetes studies but not obesity studies. Overall, disclosure of race declined over the 3 timeframes whereas individually, the disclosure of African Americans improved.
KW - Diabetes
KW - Gender
KW - K grant
KW - Minority
KW - Nih revitalization act
KW - Obesity
UR - http://www.scopus.com/inward/record.url?scp=34748875921&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34748875921&partnerID=8YFLogxK
U2 - 10.1080/08989620601003380
DO - 10.1080/08989620601003380
M3 - Article
C2 - 17849642
AN - SCOPUS:34748875921
SN - 0898-9621
VL - 13
SP - 311
EP - 324
JO - Accountability in Research
JF - Accountability in Research
IS - 4
ER -