>> Samia Noursi: I'm Samia Noursi, associate director for Science Policy Planning and Analysis at the Office of Research on Women's Health at the National Institutes of Health. Today's presentation is about women and minorities as participants in NIH clinical research and NIH-defined phase III clinical trials. In this course, I will discuss the overview of NIH inclusion policy and enrollment trends in NIH clinical research and NIH-defined phase III clinical trials from FY 2015 to FY 2018. As we go through this course, all years discussed are in reference to the fiscal year. The goal of this session is to gain an overview of inclusion policy requirements, to learn about enrollment trends in NIH clinical research and NIH-defined phase III clinical trials by minority population and racial and ethnic categories, and to understand the context behind changes in enrollment trends of NIH-funded clinical research. The NIH 1993 Revitalization Act requires that women and ethnic racial minorities be included in all NIH-funded clinical research and NIH-defined phase III clinical trials. The policy states that the inclusion of women and members of minority groups, and their subpopulations, must be addressed in developing a research design or contract proposal appropriate to the scientific objective of the study or the contract. The research plan or the proposal should describe the composition of the proposed study population in terms of sex, gender, and racial ethnic group and provide a rational for selection of such participants. Next, I will discuss data trends describing NIH inclusion data for all clinical research from 2015 to 2018 and inclusion data for NIH-defined phase III clinical trials from the same period. This graph shows that female enrollment in all NIH-funded clinical research was 61.9 percent in 2015 and gradually dropped to 47.2 percent in the year 2017. However, the proportion of women participation increased to 52.4 percent in 2018. The male enrollment increased from 36.5 percent in the year 2015, up to 50.5 percent in the year 2017. The percentage of male participants declined to 44.2 percent in 2018. However, the fluctuation in enrollee participation reflects the ending of some large clinical research studies in foreign sites. The slide showed that when female-only breast cancer studies were excluded from the distribution, the female participation remained within a range of 41.1 percent to 45.3 percent throughout these years. When male only prostate cancer studies were excluded, the enrollment remained within the range of 35.2 percent to about 46 percent across the life span. NIH-defined phase III clinical trials are a subset of NIH clinical research studies. This graph shows that the proportion of female enrollees in the year 2015 was a little bit over 67 percent and it was 65.6 percent in the year 2016. The high percentage of female enrollment occurred during this period as a result of Global Network for Women's Health and Children's Health Research Data Coordinating Center reporting, which conveyed large numbers of participants in Africa, Asia, and Latin America. The proportion of female participants dropped to 59 percent in 2017 due to the ending of the reporting from these large foreign phase III clinical trials. However, the proportion of female participants enrolled in NIH-defined phase III clinical trials increased from 59 percent in 2017 to 62.4 percent in 2018 due to the beginning of reporting for some large domestic trials. As you can see in the chart that I just added to the slide, the male enrollment from 2015 to 2018 has been 31.3 percent or higher. This graph shows that when studies recruiting only female participants are excluded from the distribution, enrollment of women declined from 65.6 percent in 2015 to 34.6 percent in 2018 due to the end of some large foreign women phase III clinical trials. The enrollment of male-only trials ranged between 31.3 percent and 39.8 percent during these years. Data from 2015 to 2018 shows that enrollment trend between females, excluding male-only trials, were narrowing over time and around 34 percent in 2018. Let's look at the trend of minority enrollment in NIH-funded clinical research. The overall proportion of enrolled participants from minority groups was 27.8 percent in 2015 for studies conducted at U.S. research sites and increased to 29.3 percent in 2018. A continuing trend of stable participation by all minority groups in NIH clinical research. These four stacked bars display the proportions of racial categories for research participants enrolled in all NIH clinical research at U.S. sites for the years 2015 to 2018. As shown, whites appear to be the highest reported participants in NIH-funded clinical research followed by the Asian population throughout these years consistently. There is an active effort going on among NIH principal investigators as well as NIH staff who are engaged to increase the participation of American Indian, Alaska native population in NIH-funded clinical research. The ethnic breakdown of the enrollees show that non-Hispanic participants appear to be the highest reported recruitment for NIH-funded clinical research. The non-Hispanic enrollment increased steadily from 67.9 percent in 2015 to 77.6 percent in 2018. The second highest reported ethnic group is the Hispanic Latinos, which stayed within the range of 9.1 percent to 10.7 percent between the years 2015 to 2018. The enrollment of NIH-defined phase III clinical trials conducted in the U.S. and its sites showed that over years there has been a decline in the percentage of minority groups enrollment. This may be explained in part by the different mission of each institute or center at NIH and we call them ICOs. Trials characteristics also vary across NIH ICOs. While some ICOs, such as the National Library of Medicine, are not necessarily expected to fund phase III clinical trials. Others, such as the National Institute of Dental and Craniofacial Research have a clinical content area mission but fund few phase III clinical trials. The inclusion of racial categories in NIH-defined phase III clinical trials reveals that whites continue to comprise a large majority of participants in phase III clinical trials. The percentages of white participants in NIH-defined phase III clinical trials increased from 65.7 percent in 2015 to 74.3 percent in 2018 while the proportion of African American participants, in comparison to whites, declined between 23.6 percent to 14.7 percent in the same time period; that is, from 23.6 percent decline to 14.7 percent in the same period. The graphs here show an increase in the reporting of non-Hispanic ethnic group participants in NIH-defined phase III clinical trials conducted in U.S. sites between the years 2015 to 2018. The Hispanic Latino participants comprised 10.7 percent of NIH-defined phase III clinical trial enrollees in the year 2018, a 3 percent increase from 2017 reported Hispanic enrollees. In summary, the aggregate enrollment data provides an overview of NIH clinical research participation and show substantial inclusion of women and minorities in clinical research projects and phase III clinical trials for U.S. populations. The overall aggregate data trends show that NIH inclusion policy is effective in recruitment and retention of women and minority population in NIH-funded clinical research. Thank you for watching this session on women and minorities as participants in NIH clinical research and NIH-defined phase III clinical trials. I hope I was able to give you an overview of this topic and thank you for watching.