# Presentation: 051146

## Summary Report of NIH Inclusion Data – FY2005

- Carlos E. Caban, Ph.D., M.P.H.
- Office of Extramural Research, OD
- NIH
- October 24, 2006

## 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

## 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.

## 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

## Slide 5

## 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

## 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 Enrollment  | 10,233 | 9,862 | 96.4% | 371 | 3.6% |
| % | 69.2% | 69.4% |   | 62.7% |   |
| Protocols with zero enrollment. Enrollment data has not yet been submitted | 4,565 | 4,344 | 95.2% | 221 | 4.8% |
|   | 30.8% | 30.6% |   | 37.3% |   |
| Total Number of Protocols | 14,798 | 14,206 | 96.0% | 592 | 4.0% |
| % | 100.0% | 100.0% |   | 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. |
|  |

## 1B. ENROLLMENT REPORTED

| 1B. ENROLLMENT REPORTED | Total All Clinical Studies* | Domestic | % | Foreign | % |
| --- | --- | --- | --- | --- | --- |
| Females Enrolled | 9,503,922 | 7,887,209 | 83.0% | 1,616,713 | 17.0% |
| % | 60.4% | 62.3% |   | 53.0% |   |
| Males Enrolled | 5,941,907 | 4,515,242 | 76.0% | 1,426,665 | 24.0% |
| % | 37.8% | 35.6% |   | 46.7% |   |
| Sex of Subjects is Unknown  | 276,923 | 267,407 | 96.6% | 9,516 | 3.4% |
| % | 1.8% | 2.1% |   | 0.3% |   |
| Total Subjects Enrolled | 15,722,752 | 12,669,858 | 80.6% | 3,052,894 | 19.4% |
| % | 100.0% | 100.0% |   | 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.

## 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 Enrolled | 15,722,752 | 12,669,858 | 80.6% | 3,052,894 | 19.4% |
| 
1C. MINORITY ENROLLMENT REPORTED | Total All Clinical Studies* | Domestic | % | Foreign | % |
| Minority Total** | 6,245,436 | 3,468,864 | 55.5% | 2,776,572 | 44.5% |
|   | 39.7% | 27.4% |   | 90.9% |   |

- 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).

| 5A. Eleven Year Increases in Protocols and Enrollment Data |  |  |  |  |
| --- | --- | --- | --- | --- |
| FY Reported | 1995 |   | 2005 | Relative Increase,   2005 / 1995 |
|   |   |   |   |   |
| Total Protocols with enrollment | 3,188 |   | 10,233 | 3.2 |
| Total Enrollment | 1,021,493 |   | 15,722,752 | 15.4 |
| Total Minorities | 374,433 |   | 6,245,436 | 16.7 |
| % of Minority | 36.7% |   | 39.7% | 1.1 |
|   |   |   |   |   |
| FY Reported | 2002 |   | 2005 | Relative Increase,  2005 / 2002 |
| Total DOMESTIC Enrollment data | 10,192,401 |   | 12,669,858 | 1.2 |
| Total FOREIGN Enrollment  | 946,083 |   | 3,052,894 | 3.2 |

## Slide 11

| 5B. Eleven Year Summary of Total Protocols Reported in FY 1995-2005 |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- |
|   |  |  |  |  |  |   |
| FY Reported | FY 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 DomesticProtocols | Protocol Form* |
| 1995 | 1994 | 3,188 |   |   |   | Old |
| 1996 | 1995 | 6,036 |   |   |   |  |
| 1997 | 1996 | 5,692 |   |   |   |  |
| 1998 | 1997 | 7,602 |   |   |   |  |
| 1999 | 1998 | 8,285 |   |   |   |  |
| 2000 | 1999 | 9,390 |   |   |   |  |
| 2001 | 2000 | 10,212 |   |   |   |  |
|   |   |   |   |   |   |   |
| 2002 | 2001 | 8,945 | 8,463 | 482 | 94.6% | Old + New |
| 2003 | 2002 | 10,216 | 9,578 | 638 | 93.8% |  |
| 2004 | 2003 | 10,125 | 9,760 | 365 | 96.4% |  |
| 2005 | 2004 | 10,233 | 9,862 | 371 | 96.4% |  |

## Eleven Year Trends for Protocol and Enrollment Data: 1995-20055B.Eleven Year Summary of Total Protocols Reported in FY 1995-2005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 2002-2005 reports.

## Slide 13

| 5C. Comparison of Domestic and Foreign Enrollment Reported in FY 2002-2005 |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- |
|   |  |  |  |  |  |   |
| FY Reported | FY Funded | Total Enrollment data
(Old+New Forms): | Total DOMESTIC
Enrollment data | Percent
DOMESTIC
Enrollment | Total FOREIGN Enrollment  | Percent FOREIGN
Enrollment |
| 2002 | 2001 | 11,138,484 | 10,192,401 | 91.5% | 946,083 | 8.5% |
| 2003 | 2002 | 14,772,254 | 11,911,357 | 80.6% | 2,860,897 | 19.4% |
| 2004 | 2003 | 18,923,920 | 14,359,793 | 75.9% | 4,564,127 | 24.1% |
| 2005 | 2004 | 15,722,752 | 12,669,858 | 80.6% | 3,052,894 | 19.4% |

## 5C. Comparison of Domestic and Foreign Enrollment Reported in FY 2002-2005Percent Comparison of Domestic and Foreign Enrollment

## 6A.Sex/Gender Enrollment by Year Reported

## 6F. Comparison of Domestic and Foreign Minority  Participation for FY 2002-2005

| FY
Reported | FY Funded | FOREIGN
Minority
Enrollment | Foreign
Total
Enrollment | DOMESTIC
Minority
Enrollment | Domestic
Total
Enrollment |
| --- | --- | --- | --- | --- | --- |
| 2002 | 2001 | 777,461 | 946,083 | 2,754,820 | 10,149,869 |
|   |   | 82.2% | 100.0% | 27.1% | 100.0% |
| 2003 | 2002 | 2,452,329 | 2,860,897 | 2,935,363 | 11,911,357 |
|   |   | 85.7% | 100.0% | 24.6% | 100.0% |
| 2004 | 2003 | 4,147,255 | 4,564,127 | 3,464,356 | 14,359,793 |
|   |   | 90.9% | 100.0% | 24.1% | 100.0% |
| 2005 | 2004 | 2,776,565 | 3,052,894 | 3,468,864 | 12,669,858 |
|   |   | 90.9% | 100.0% | 27.4% | 100.0% |

##  Number of Minority Participants for FY2002-2005

-  Number of Minority Participants for FY2002-2005

- Comparison of % Domestic Minority Enrollment to Total Domestic Enrollment

## 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