October 24, 2006 Advisory Committee on Research on Women’s Health. 1 Summary Report of NIH Inclusion Data – FY2005 Carlos E. Caban, Ph.D., M.P.H. Office of Extramural Research, OD NIH October 24, 2006

Advisory Committee on Research on Women’s Health. 2 Overview of the Report Data Executive Summary Tables Total NIH Clinical Research Reported in FY2005 is summarized in revised tables Trend Data is provided for up to 11 years Comparisons available include: –All Clinical Research versus NIH Defined Phase III Trials –Female versus Male participation –Extramural versus Intramural Studies –Domestic versus Foreign Studies –Summary of Minority Data –Trends for up to 11 years Appendix Tables Appendix H: Race and Ethnicity Categories Included in Summary Minority Data

October 24, 2006 Advisory Committee on Research on Women’s Health. 3 NIH Clinical Research NIH Clinical research studies are determined in accordance with the definition of clinical research to include, for example, non- intervention clinical research, clinical trials, epidemiologic studies, behavioral studies, and database studies. Data on inclusion is tabulated by looking at human subject populations in NIH-defined Phase III clinical trials and other human subject research studies. "Total All Clinical Studies" includes NIH Defined Phase III Clinical Trials.

October 24, 2006 Advisory Committee on Research on Women’s Health. 4 A. Executive Summary Tables: NIH Wide Clinical Research Reported in FY2005 Tables Summary: NIH Clinical Research – Overview – Reported in FY Summary of NIH Clinical Research 2. Summary of Sex-Specific Protocols, Summary: NIH Defined Phase III Research – Overview- FY Summary of NIH Phase III Clinical Research 4. Summary of NIH Phase III Sex-Specific Protocols Summary: Eleven Year Trend Reports: FY Summary: Eleven Year Trend Report 6. Eleven Year Minority Trend Report 7. Eleven Year Minority Trend Report...Phase III 8. Domestic Protocols: Domestic Protocols, NIH Phase III: Foreign Protocols: Foreign Protocols, Phase III:

October 24, 2006 Advisory Committee on Research on Women’s Health. 5

October 24, 2006 Advisory Committee on Research on Women’s Health. 6 Brief Data Summary Brief Presentations: Summary of NIH Clinical Research Reported in FY2005 – Table 1 Presentation of Trend Data – –Female and Male Enrollment –Protocols and Enrollment –Domestic and Foreign –Minority Inclusion

October 24, 2006 Advisory Committee on Research on Women’s Health. 7 Table 1. Summary of NIH Clinical Research Reported in FY2005 : Total Number of Protocols & Enrollment By Sex & Domestic vs. Foreign Protocols 1A. PROTOCOLS REPORTED 1A. PROTOCOLS REPORTED Total All Clinical Studies*Domestic%Foreign% Protocols with Enrollment10,2339, %3713.6% %69.2%69.4% 62.7% Protocols with zero enrollment. Enrollment data has not yet been submitted4,5654, %2214.8% 30.8%30.6% 37.3% Total Number of Protocols14,79814, %5924.0% %100.0% 1. Total number of protocols reported in the NIH database in FY2005 was 14,798; of these, 10,233(69.2%) reported subject enrollment. 2. Subsequent Tables reporting "Enrollment Reported" are based on the 10,233 protocols reporting subject enrollment, or a defined subset. 3. Protocols with zero enrollment (data not yet submitted) are not included in subsequent tables reporting "Enrollment reported." 4. Domestic protocols made up the vast majority of protocols (14,206; 96.0%); of these, 9,862 (69.4%) reported domestic subject enrollment.

October 24, 2006 Advisory Committee on Research on Women’s Health. 8 1B. ENROLLMENT REPORTED Total All Clinical Studies*Domestic%Foreign% Females Enrolled9,503,9227,887, %1,616, % %60.4%62.3% 53.0% Males Enrolled5,941,9074,515, %1,426, % %37.8%35.6% 46.7% Sex of Subjects is Unknown276,923267, %9,5163.4% %1.8%2.1% 0.3% Total Subjects Enrolled15,722,75212,669, %3,052, % %100.0% 1. The total "Enrollment Reported" in the NIH database in FY2005 was 15, 722, 752 subjects in 10,233 protocols with enrollment. 2. Females made up 60.4% (9.5M) of the total subjects enrolled, while Males made up 37.8%(5.9M), with 1.8% (.277M) unknown. 4. The total Domestic Enrollment reported was 12,669,858 (80.6%). 5. Females made up 62.3%(7.9M) of the domestic subjects enrolled, while Males made up 35.6%(4.5M), with 2.1%(.267M) unknown.

October 24, 2006 Advisory Committee on Research on Women’s Health. 9 1C. MINORITY ENROLLMENT REPORTED 1. Minorities made up 39.7% of total subjects enrolled. 2. Minorities made up 27.4%(3.47M) of the Domestic Enrollment and 90.9% of the Foreign Enrollment. 3. The Total Minority Enrollment was made up of 55.5% Domestic and 44.5% Foreign enrollment. The small percentage of foreign protocols (4%) account for a significant proportion (44.5%) of the Total Minority Enrollment. Total All Clinical Studies*Domestic%Foreign% 1B. Total Subjects Enrolled15,722,75212,669, %3,052, % 1C. MINORITY ENROLLMENT REPORTED Total All Clinical Studies*Domestic%Foreign% Minority Total**6,245,4363,468, %2,776, % 39.7%27.4% 90.9%

October 24, 2006 Advisory Committee on Research on Women’s Health There was a 3.2 fold increase in protocols, from 3,188 protocols to 10,233 protocols. 2. There was a 15.4 fold increase in enrollment, from approximately 1.0M to 15.7 M. 3. There was a 16.7 fold increase in minority enrollment, from 0.37M to 6.2 M. 4. Domestic and Foreign data (FY ), and showed 1.2 fold increase in domestic enrollment (from 10.2M to 12.7M) and a 3.2 fold increase in foreign enrollment (from 0.95M to 3.0M). 5A. Eleven Year Increases in Protocols and Enrollment Data FY Reported Relative Increase, 2005 / 1995 Total Protocols with enrollment3,188 10, Total Enrollment1,021,493 15,722, Total Minorities374,433 6,245, % of Minority36.7% 39.7%1.1 FY Reported Relative Increase, 2005 / 2002 Total DOMESTIC Enrollment data10,192,401 12,669, Total FOREIGN Enrollment 946,083 3,052,8943.2

October 24, 2006 Advisory Committee on Research on Women’s Health. 11 5B. Eleven Year Summary of Total Protocols Reported in FY FY ReportedFY Funded Number of Protocols with Enrollment data (Old + New Forms): Number of DOMESTIC Protocols with Enrollment data Number of FOREIGN Protocols with Enrollment data Percent Domestic Protocols Protocol Form* ,188 Old , , , , , , ,9458, % Old + New ,2169, % ,1259, % ,2339, %

October 24, 2006 Advisory Committee on Research on Women’s Health. 12 Eleven Year Trends for Protocol and Enrollment Data: B.Eleven Year Summary of Total Protocols Reported in FY Total Protocols by Year Reported Note: The arrow in the graph indicates that the old Form was used until 2001 reports, and both the OLD and NEW FORMS were used for reports.

October 24, 2006 Advisory Committee on Research on Women’s Health. 13 5C. Comparison of Domestic and Foreign Enrollment Reported in FY FY ReportedFY Funded Total Enrollment data (Old+New Forms): Total DOMESTIC Enrollment data Percent DOMESTIC Enrollment Total FOREIGN Enrollment Percent FOREIGN Enrollment ,138,48410,192, %946,0838.5% ,772,25411,911, %2,860, % ,923,92014,359, %4,564, % ,722,75212,669, %3,052, %

October 24, 2006 Advisory Committee on Research on Women’s Health. 14 5C. Comparison of Domestic and Foreign Enrollment Reported in FY Percent Comparison of Domestic and Foreign Enrollment

October 24, 2006 Advisory Committee on Research on Women’s Health. 15 6A.Sex/Gender Enrollment by Year Reported

October 24, 2006 Advisory Committee on Research on Women’s Health. 16 6F. Comparison of Domestic and Foreign Minority Participation for FY FY ReportedFY Funded FOREIGN Minority Enrollment Foreign Total Enrollment DOMESTIC Minority Enrollment Domestic Total Enrollment ,461946,0832,754,82010,149, %100.0%27.1%100.0% ,452,3292,860,8972,935,36311,911, %100.0%24.6%100.0% ,147,2554,564,1273,464,35614,359, %100.0%24.1%100.0% ,776,5653,052,8943,468,86412,669, %100.0%27.4%100.0%

October 24, 2006 Advisory Committee on Research on Women’s Health. 17 Number of Minority Participants for FY Comparison of % Domestic Minority Enrollment to Total Domestic Enrollment

October 24, 2006 Advisory Committee on Research on Women’s Health. 18 General Summary The number of clinical studies and total and minority enrollment have increased significantly over 11 years More Females have been reported than males, although the F/M ratio is relatively constant The vast majority are domestic studies Domestic minority enrollment has been ~25% of total domestic enrollment