Summary Report of NIH Inclusion Data – FY2005

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 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. 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 FY2005 1. Summary of NIH Clinical Research 2. Summary of Sex-Specific Protocols, Summary: NIH Defined Phase III Research – Overview- FY2005 3. Summary of NIH Phase III Clinical Research 4. Summary of NIH Phase III Sex-Specific Protocols Summary: Eleven Year Trend Reports: FY1995-2005 5. Summary: Eleven Year Trend Report 6. Eleven Year Minority Trend Report 7. Eleven Year Minority Trend Report...Phase III 8. Domestic Protocols: 2002-2005 9. Domestic Protocols, NIH Phase III: 2002-2005 10. Foreign Protocols: 2002-2005 11. Foreign Protocols, Phase III: 2002-2005 Advisory Committee on Research on Women’s Health.

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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 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 Advisory Committee on Research on Women’s Health.

8. 1B. ENROLLMENTREPORTED 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. Advisory Committee on Research on Women’s Health.

9. 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. 1C. MINORITY ENROLLMENT REPORTED Advisory Committee on Research on Women’s Health.

10. 1. 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 2002-2005), 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). Advisory Committee on Research on Women’s Health.

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12. Eleven Year Trends for Protocol and Enrollment Data: 1995-20055B.Eleven Year Summary of Total Protocols Reported in FY 1995-2005Total 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 2002-2005 reports. Advisory Committee on Research on Women’s Health.

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14. 5C. Comparison of Domestic and Foreign Enrollment Reported in FY 2002-2005Percent Comparison of Domestic and Foreign Enrollment Advisory Committee on Research on Women’s Health.

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

16. 6F. Comparison of Domestic and Foreign Minority Participation for FY 2002-2005 Advisory Committee on Research on Women’s Health.

17. Number of Minority Participants for FY2002-2005 Comparison of % Domestic Minority Enrollment to Total Domestic Enrollment 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 Advisory Committee on Research on Women’s Health.