# Presentation: 663706

## National Cancer Advisory Board

- Biennial Review of Inclusion of Women and Minorities in Clinical Research
**February 2007**

## NIH Policy on Inclusion of Women and Minorities in Clinical Research

- Why does NIH have this policy?
- Mandated by Congress in 1993, Public Law 103-43.
- Ethical principle of justice and importance of balancing research burdens and benefits.

## Public Law PL 103-43

- Women and minorities _must_ be included in all clinical research studies.
- Women and minorities _must_ be included in Phase III clinical trials, and the trial must be designed to permit valid analysis.
- For the purpose of this policy, _Valid Analysis_ means an unbiased assessment that does not require high statistical power and should be conducted for both large and small studies.

## Public Law PL 103-43

- Cost is _not_ allowed as an acceptable reason for exclusion.
- NIH supports outreach efforts to recruit and retain women, minorities, and their subpopulations in clinical studies.

## NIH Revitalization Act of 1993

***“******The Advisory Council of each National Institute shall prepare biennial reports describing the manner in which the institute has complied with this section.”***
- Done in odd-numbered years.

## NIH Report Approach

- A summary report is prepared centrally by the NIH Office of Research on Women’s Health and includes statement that the NCAB reviews.
- NCI procedures for implementation of the NIH policy for inclusion of women and minorities in clinical studies.
- The results of that implementation.
- NCI compliance.

## NCI  Coordination Division of Extramural Activities

-      Implements Inclusion Policy at NCI
- Institute-wide coordination and communication
- Accrual Working Group –Division Reps
- Information, Training, Problem Solving

## NCI Procedures for Implementation of NIH Policy

***POLICY DISSEMINATION***
- HSAs work with applicants to disseminate requirements *(NIH Guide and NCI and NIH Websites).*
- NCI extramural staff are kept up-to-date via trans-NIH education programs and desktop distribution of policies and procedures.

## NCI Procedures for Implementation of NIH Policy

***PRE-AWARD ACTIVITIES***
- Peer reviewers receive instruction on policies and evaluate inclusion plans.
- Where concerns are noted, bars to award are put in place. NCI staff work with applicants to ensure appropriate revisions are made.
- Applications with bars are identified in a closed NCAB session, and a subsequent resolution is reported.

## NCI Procedures for Implementation of NIH Policy

***POST-AWARD MONITORING***
- Awardees report cumulative accrual annually.
- Progress of studies and cumulative accruals are reviewed by Program Directors.
- Target and enrollment numbers are entered into the NIH Population Tracking application.
- Staff provide oversight, advice, and assistance and work with awardees to disseminate findings and encourage new studies.

## NCI Procedures for Implementation of NIH Policy

***AGGREGATE REPORTING***
- NIH requires a format that aggregates all Phase III clinical trials whether treatment, behavioral, or epidemiologic observation.
- Individual clinical trials vary considerably.
- Large population-based screening trials dominate aggregate data.

## NIH Policy for Inclusion Updated to Meet New OMB Standards

- OMB Directive 15 issued in 1997:
- Created racial and ethnic standards for Federal statistics and administrative reporting.
- Effective date no later than January 1, 2003.

## Change in Requirements for Population Types

- Made changes in categories to correspond to the 2000 census data collection, i.e., “Hispanic” is an ethnic category.
- Data now to be collected in 3 categories (ethnicity, race, and sex/gender) rather than 2 categories (race and sex/gender).
- Old form versus new form creates transition challenges.

## Change in Reporting Categories

|  | Old Form | New Form |
| --- | --- | --- |
| Ethnicity |  | Hispanic, Non-Hispanic  |
| Race | Asian | Asian |
|  | Black | Black |
|  |  | Hawaiian/Pacific Islander |
|  | Hispanic |  |
|  | Native American and
Alaska Native | Native American and
Alaska Native |
|  | White | White |
|  |  | More Than One Race |
|  | Unknown (or Other) | Unknown (or Other) |

## Instructions in PHS 398

- Inclusion of women and minorities sections must include:
- Subject selection criteria and rationale.
- Rationale for any exclusions.
- Enrollment dates (start and end).
- Outreach plans for recruitment.
- Proposed composition using new tables.

## Accrual to NCI Clinical Trials

- Data include epidemiological, population-based interventions and therapeutic trials according to the NIH definition of clinical research.
- Subset analyses by race, ethnicity, and sex/gender are required of all Phase III clinical trials with initial funding after 1995.
- Current reporting cycle covers data reported in FY2005 and 2006, which represents subjects enrolled in FY2004 and 2005.

## Requirements for NIH-Defined Phase III Clinical Trials 

- Definition:   Broadly based prospective Phase III clinical investigation,
- usually involving several hundred or more human subjects,
- for the purpose of evaluating an experimental intervention or comparing two or more existing treatments.
- Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care.

## US 2000 Census Data

|  |  | American Indian | Asian | Black | White  | Other |
| --- | --- | --- | --- | --- | --- | --- |
| Race alone | #
% | 2.5
0.9 | 10.2
3.6 | 34.7
12.3 | 211.5
75.1 | 19.4
6.7 |
| *More than one Race | #
% | 4.1
1.5 | 11.9
4.2 | 36.4
12.9 | 216.9
77.1 |  |
| 
Hispanic     35.3 million = 12.5%   (47.9% White) |  |  |  |  |  |  |
| Total population 281.4 million
* 2.4% of respondents |  |  |  |  |  |  |

**US 2000 Census Data**

## US Cancer Incidence Rates*

|  | All | American Indian | Asian | Black | White  | Hispanic |
| --- | --- | --- | --- | --- | --- | --- |
| Rate per 
100,000 | 471.3 | 325.8 | 315.6 | 504.4 | 478.4 | 353.1 |
| EstimatedCases, in thousands | 1,326 | 8 | 32 | 175 | 1,012 | 125 |
| EstimatedPercent |  | 0.6 | 2.4 | 13.2 | 76.3 | 9.4 |

**US Cancer Incidence Rates***

- *US Cancer Incidence estimated from SEER Incidence Rates for 2000-2003 and US 2000 Census data.

## Enrollment for ExtramuralResearch Studies by Sex/Gender

| Sex/Gender | Enrolled | Percent |
| --- | --- | --- |
| Female | 3,344,210 |    81.5 |
| Male |    732,562 |    17.9 |
| Unknown |      25,171 |      0.6 |
| Total | 4,101,943 |  100.0 |
|  |  |  |
| Sex/Gender | Enrolled | Percent |
| Female | 3,801,558 |    83.3 |
| Male |    728,295 |    16.0 |
| Unknown |      32,591 |      0.7 |
| Total | 4,562,444 |  100.0 |

**2005**
**2,117 Studies**

**2006**
**2,447 Studies**

## Sex/Gender Enrollments  without All Male and All Female Studies  2006—1,748 Studies*

| Sex/Gender |    Enrollment | Percent
of Total | US Cancer Incidence** |
| --- | --- | --- | --- |
| Female | 657,279 | 53.2 | 43.7 |
| Male | 545,386 | 44.2 | 56.3 |
| Other/Unknown | 32,591 |   2.6 |  |
| Total | 1,235,256 | 100.0 | 100.0 |

- *Subset of studies reported for 2006; Studies include both Male and Female enrollment.
- **US Cancer Incidence estimated from SEER Incidence Rates for 2000-2003 and US 2000 Census data.

**Notes:**
All slides refer to the Report Year – i.e., the fiscal year in which the grant was funded.  The accrual data reported is for the previous data collection period (i.e, the previous year).  
In this slide, the 2001 report shows the accrual data for 2000 (i.e. the past year’s data collection period). 

Data checked and corrected. 2/7/03 meh

## FY 2005 Enrollment  Extramural Research Studies  Old Format  - 615 Studies

| Race/Ethnicity | Number on Study |    Percent on Study | US Cancer Incidence** |
| --- | --- | --- | --- |
| White | 183,329 |      78.5 | 76.3 |
| Black |    17,649 |        7.6 | 13.2 |
| Other |     13,142 |        5.6 |  |
| Asian/ Pacific Islander |      9,327 |        4.0   | 2.4 |
| Hispanic |      9,113 |        3.9 | (9.4)* |
| American Indian/ Alaska Native |         814 |        0.4 | 0.6 |
| Total |   233,374 |       100 | 100.00 |

- *Percent Hispanic incidence included in other categories.
- **US Cancer Incidence estimated from SEER Incidence Rates for 2000-2003 and US 2000 Census data.

**Notes:**
All slides refer to the Report Year – i.e., the fiscal year in which the grant was funded.  The accrual data reported is for the previous data collection period (i.e, the previous year).  
In this slide, the 2001 report shows the accrual data for 2000 (i.e. the past year’s data collection period). 

Data checked and corrected. 2/7/03 meh

## FY 2005 Enrollment  Extramural Research Studies  New Format - 1,502 Studies

| Race/Ethnicity |      Count |  Percent of Total | US Cancer Incidence*  |
| --- | --- | --- | --- |
| White |     2,527,716 |    65.3 | 76.3 |
| Unknown/Not Reported |       395,093 |     10.2 |  |
| Asian |        329,734 |     8.5 | 2.4 |
| Black or African American |        308,597 |     8.0 | 13.2 |
| Hispanic or Latino |        (286,884)      |     (7.4) | (9.4) |
| American Indian/Alaska Native  |        250,034 |    6.5 | 0.6 |
| More Than One Race |          36,087 |     0.9 |  |
| Native Hawaiian/ Pacific Islander |           21,308 |     0.6 |  |
| Total  |    3,868,569 |   100.0 | 100.0 |

**FY 2005 Enrollment  ****Extramural Research Studies **** New Format - 1,502 Studies**

- *US Cancer Incidence estimated from SEER Incidence Rates for 2000-2003 and US 2000 Census data.

## FY 2006 Enrollment  Extramural Research Studies Old Format - 599 Studies

| Race/Ethnicity | Number on Study | Percent on Study | US Cancer Incidence** |
| --- | --- | --- | --- |
| White |      182,143 |  82.9 | 76.3 |
| Other |         13,652 |     6.2 |  |
| Black |        13,251 |     6.0 |   13.2 |
| Hispanic |          6,483 |     3.0 |    (9.4)*           |
| Asian/Pacific Islander |          3,544 |     1.6 |   2.4 |
| American Indian/ Alaska Native |             627 |     0.3 |    0.6 |
| Total |      219,700 | 100.0 |  100.0 |

- *Percent Hispanic US Cancer Incidence included in other categories.
- **US Cancer Incidence estimated from SEER Incidence Rates for 2000-2003 and US 2000 Census data.

**Notes:**
2002 refers to the fiscal year in which the grant was funded; progress reports present accrual data for the previous year, i.e., year 2001.  Accrual data is presented as cumulative data since the inception of the study. Includes grants and contracts.  

 Date checked and corrected 2/7/03 meh 

## FY 2006 Enrollment  Extramural Research Studies  New Format - 1,848 Studies

| Race/Ethnicity |      Count |  Percent of Total | US Cancer Incidence* |
| --- | --- | --- | --- |
| White |     2,866,135 |   66.0 |  76.3 |
| Unknown/Not Reported |         529,602 |     12.2 |  |
| Asian |         518,571 |     11.9 |   2.4 |
| Black or African American |        324,326 |     7.5 |  13.2 |
| Hispanic or Latino |      (303,421)     |     (7.0) |  (9.4) |
| American Indian/ Alaska Native  |           50,466 |     1.2 |  0.6 |
| More Than One Race |           35,555 |     0.8 |      |
| Native Hawaiian/ Pacific Islander |           18,089 |     0.4 |    |
| Total  |      4,342,744 |   100.0 | 100.0 |

**FY 2006 Enrollment  ****Extramural Research Studies **** New Format - ****1,848**** Studies**

- *US Cancer Incidence estimated from SEER Incidence Rates for 2000-2003 and US 2000 Census data.

## Ethnic CategoriesNew Format FY 2005 and 2006

|  | FY2005
1,502 Studies |  | FY2006
1,848 Studies |  | U.S. Cancer Incidence** |
| --- | --- | --- | --- | --- | --- |
|  | Count | Percent
of Total |    Count | Percent 
of Total | Percent
of Total |
| Not Hispanic | 3,180,289 | 82.2 | 3,452,186 |     79.5 | 90.6*
 |
| Unknown or Not Reported | 401,396 | 10.4 |    587,137 |     13.5 |  |
| Hispanic or Latino | 286,884 |    7.4 |    303,421 |       7.0 | 9.4 |
| Total | 3,868,569 | 100.0 | 4,342,744 |   100.0 | 100.0
 |

- *Includes non-hispanic and those of unknown or not reported ethnicity.
- **US Cancer Incidence estimated from SEER Incidence Rates for 2000-2003 and US 2000 Census data.

## FY 2005 - NCI Enrollment Extramural Phase III Research Studies Old Format - 158 Studies

| Race/Ethnicity | Number 
On Study | Percent
On Study | US Cancer Incidence* |
| --- | --- | --- | --- |
| White | 130,979 |   82.2 | 76.3 |
| Black |   14,265 |     9.0 | 13.2 |
| Hispanic |     7,581 |     4.8 |           (9.4) |
| Unknown/Other |     2,973 |     1.9 |  |
| Asian/Pacific Islander |     2,898 |     1.8 | 2.4 |
| American Indian/ Alaska Native |        591 |     0.4 | 0.6 |
| Total | 159,287 | 100.0 | 100.0 |

- *US Cancer Incidence estimated from SEER Incidence Rates for 2000-2003 and US 2000 Census data.

**Notes:**
Corrected data to be entered.

## FY 2005 - NCI Enrollment Extramural Phase III Research StudiesNew Format - 92 Studies

| Race/Ethnicity | Count | Percent of Total |
| --- | --- | --- |
| White | 38,617 |     84.1 |
| Unknown/Not Reported |   2,123 |       4.6 |
| Asian |   1,968 |      4.3 |
| Black or African American |   1,920 |      4.2 |
| Hispanic or Latino |   (1,866) |      (4.1) |
| More Than One Race |      836 |       1.8 |
| Amer. Indian/Alaska Native |      253 |       0.6 |
| Hawaiian/Pacific Islander |      217 |       0.5 |
|  |  |  |
| Total | 45,934 |   100.0 |

**Notes:**
Data checked and corrected 2/7/03 meh.

## FY 2006 - NCI Enrollment Extramural Phase III Research Studies Old Format - 171 Studies

| Race/Ethnicity | Number 
On Study | Percent
On Study | US Cancer Incidence* |
| --- | --- | --- | --- |
| White | 103,827 | 82.0 | 76.3 |
| Black |    10,014 |   7.9 | 13.2 |
| Hispanic |      4,959 |   3.9 | (9.4)  |
| Unknown/Other |      4,856 |   3.8 |  |
| Asian/Pacific Islander |      2,496 |   2.0 | 2.4 |
| American Indian/ Alaska Native |         425 |   0.3 | 0.6 |
| Total |  126,577 | 100.0 |   100.0 |

- *US Cancer Incidence estimated from SEER Incidence Rates for 2000-2003 and US 2000 Census data.

**Notes:**
Corrected data to be entered.

## FY 2006 - NCI Enrollment Extramural Phase III Research Studies New Format - 126 Studies

| Race/Ethnicity | Count | Percent of Total |
| --- | --- | --- |
| White | 55,655 |    80.7 |
| Unknown/Not Reported |   5,201 |     7.5 |
| Black or African American |   3,724 |     5.4 |
| Hispanic or Latino |  (3,312) |   (4.8) |
| Asian |   2,635 |     3.8 |
| More Than One Race |     995 |     1.4  |
| Amer. Indian/ Alaska Native |    416 |    0.6 |
| Native Hawaiian/ Pacific Islander |     312 |     0.5 |
| Total | 68,938 | 100.0 |

**Notes:**
Data checked and corrected 2/7/03 meh.

## FY 2005 and 2006 NCI EnrollmentExtramural Phase III Research Studies by Sex/Gender 

| Sex/Gender | Count | Percent of Total |
| --- | --- | --- |
| Female |  113,612 |   55.4 |
| Male |    91,277 |   44.5 |
| Unknown |        332 |    0.2 |
| Total | 205,211 | 100.0 |
| Sex/Gender | Count | Percent of Total |
| Female | 121,811 |   62.3 |
| Male |   72,404 |   37.0 |
| Unknown |     1,300 |     0.7 |
| Total | 195,515 | 100.0 |

**FY 2005**
**250 Trials**

**FY 2006**
**297 Trials**

**Notes:**
2001 Report of accrual for 2000.  2002 Report of accrual for 2001.  Annual accrual shown for each year.

Data was checked and corrected 2/7/03 meh.  Needs addl column with US comparison .

## Intramural Research StudiesFY 2005 – Old Format Data – 176 Studies 

| Race/Ethnicity | Number on 
Study | Percent of Total |
| --- | --- | --- |
| White | 238,500 |   55.7 |
| Asian/Pacific Islander | 128,287 |   30.0 |
| Unknown/Other |   39,568 |     9.2 |
| Black |   11,833 |     2.8 |
| Hispanic |     9,209 |     2.2 |
| American Indian/Alaska Native |       704 |     0.2 |
|  |  |  |
| Total | 428,101 | 100.0 |

**Notes:**
Data checked and corrected 2/7/03 meh.

## Intramural Research Studies FY 2005New Format Data – 191 Studies 

| Ethnicity | Count | Proportion 
on Trials |
| --- | --- | --- |
| Not Hispanic or Latino | 901,611 |   97.0 |
|  |  |  |
| Hispanic or Latino |   16,688 |     1.8 |
|  |  |  |
| Not Reported/Unknown |   11,444 |     1.2 |
|  |  |  |
| Total |   929,743 |   100.0 |

**Notes:**
Data checked and corrected 2/7/03 meh.

## Intramural Research Studies FY 2005New Format Data – 191 Studies 

| Race | Count | Percent of Total |
| --- | --- | --- |
| White | 818,226 |   88.0 |
| Unknown/Not Reported | 34,690 |     3.7 |
| Black or African American | 33,602 |     3.6 |
| Asian | 32,915 |     3.5 |
| More Than One Race |     7,009 |     0.8 |
| American Indian/Alaska Native |   3,254 |     0.4 |
| Hawaiian/Pacific Islander |         47 |       0.01 |
|  |  |  |
| Total | 929,743 | 100.0 |

**Notes:**
Data checked and corrected 2/7/03 meh.

## Intramural Research Studies  FY 2005 Accrual by Sex/Gender367 Studies

| Sex/Gender |    Count | Percent
of Total | US Cancer Incidence* |
| --- | --- | --- | --- |
| Female | 721,923 |   53.2 | 43.7 |
| Male | 631,500 |   46.5 | 56.3 |
| Other/ Unknown | 4,421 |     0.3 |  |
| Total | 1,357,844 | 100.0 | 100.0 |

- *US Cancer Incidence estimated from SEER Incidence Rates for 2000-2003 and US 2000 Census data.

**Notes:**
All slides refer to the Report Year – i.e., the fiscal year in which the grant was funded.  The accrual data reported is for the previous data collection period (i.e, the previous year).  
In this slide, the 2001 report shows the accrual data for 2000 (i.e. the past year’s data collection period). 

Data checked and corrected. 2/7/03 meh

## CTEP Treatment Trials Cumulative EnrollmentFY 1995–2006

| Race/Ethnicity | Count | Percent 
of Total |
| --- | --- | --- |
| White | 262,817 |   83.1 |
| Black or African American | 26,499 | 8.4 |
| Unknown | 15,762 | 5.0 |
| Asian | 6,113 | 1.9 |
| Not Reported | 2,762 | 0.9 |
| American Indian/Alaska Native | 1,178 | 0.4 |
| Native Hawaiian/Pacific Islander | 916 | 0.3 |
| More Than One Race | 197 | 0.1 |
| Total | 316,244 | 100.0 |

**N=3,359**

## CTEP Treatment Trials Cumulative Enrollment FY 1995–2006  by Gender

| Gender | Count | Percent of Total |
| --- | --- | --- |
| Female | 188,206 | 59.5 |
| Male | 121,755 | 38.5 |
| Unknown | 6,279 | 2.0 |
| Not Reported | 4 | < 0.1 |
| Total | 316,244 | 100.0 |

**N=3,359**

## CTEP Treatment Trials Cumulative Enrollment FY 1995–2006 by Gender (excluding Gender Specific Trials)

| Sex/Gender | Count | Percent of Total |
| --- | --- | --- |
| Female | 70,262 | 40.6 |
| Male | 102,313 | 59.1 |
| Unknown | 402 | 0.2 |
| Total | 172,977 | 100.0 |

**N=2,612**

## CTEP Treatment Trials FY 2005 Enrollment  

| Ethnicity | Count | Percent of Total |
| --- | --- | --- |
| Not Hispanic or Latino | 28,824 | 80.9 |
| Unknown | 4,270 | 13.4 |
| Hispanic or Latino | 1,657 | 5.2 |
| Not Reported | 166 | 0.5 |
| Total | 31,917 | 100.0 |
| Race | Count | Percent of Total |
| White | 27,186 |   85.2 |
| Black or African American | 2,441 |     7.6 |
| Unknown | 1,000 |     3.1 |
| Asian | 807 |     2.5 |
| Not Reported | 196 |     0.6 |
| American Indian or Alaska Native | 145 |     0.5 |
| Native Hawaiian/Pacific Islander | 84 |     0.3 |
| More Than One Race | 58 |     0.2 |
| Total | 31,917 | 100.0 |

**N=967**

## CTEP Treatment Trials FY 2006 Enrollment 

| Ethnicity | Count | Percent of Total |
| --- | --- | --- |
| Not Hispanic or Latino | 26,720 | 81.2 |
| Unknown | 4,201 | 12.8 |
| Hispanic or Latino | 1,714 | 5.2 |
| Not Reported | 265 | 0.8 |
| Total | 32,900 | 100.0 |
| Race | Count | Percent of Total |
| White | 27,608 | 83.9 |
| Black or African American | 2,390 | 7.3 |
| Unknown | 1,597 | 4.9 |
| Asian | 768 | 2.3 |
| Not Reported | 272 | 0.8 |
| American Indian or Alaska Native | 140 | 0.4 |
| Native Hawaiian/Pacific Islander | 62 | 0.2 |
| More Than One Race | 63 | 0.2 |
| Total | 32,900 | 100.0 |

**N=916**

## CTEP Treatment Trials FY 2005 and 2006 Enrollment by Gender

| FY2005 (N=967) |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- |
| Sex/Gender | Count |  |  | Percent of Total | U.S. Lifetime Cancer Prevalence* |
| Female | 17,473 |  |  | 54.7 | 55.3 |
| Male  | 11,803 |  |  | 37.0 | 44.7 |
| Unknown | 2,641 |  |  | 8.3 | - |
| Total | 31,917 |  |  | 100.0 | 100.0 |
| FY2006 (N=916) |  |  |  |  |  |
| Sex/Gender | Count |  |  | Percent of Total | U.S. Lifetime Cancer Prevalence* |
| Female | 19,176 |  |  | 62.0 | 55.3 |
| Male | 11,047 |  |  | 38.0 | 44.7 |
| Unknown | 2,677 |  |  | 8.1 | - |
| Total | 32,900 |  |  | 100.0 | 100.0 |

- * SEER Data (Fast Stats), US estimated prevalence counts on 1/1/2003

## CTEP Treatment Trials FY05 and 06 Enrollment by Gender (excluding Gender Specific Trials)

| FY2005(N=762)  |  |  |  |
| --- | --- | --- | --- |
| Sex/Gender | Count | Percent of Total | U.S. Lifetime Cancer Prevalence* |
| Female | 7,191 | 41.3 | 55.3 |
| Male  | 10,148 | 58.2 | 44.7 |
| Unknown | 85 | 0.5 | - |
| Total | 17,424 | 100.0 | 100.0
 |
| FY2006 (N=732) |  |  |  |
| Sex/Gender | Count | Percent of Total | U.S. Lifetime Cancer Prevalence* |
| Female | 6,902 | 42.5 | 55.3 |
| Male | 9,265 | 57.1 | 44.7 |
| Unknown | 56 | 0.3 | - |
| Total | 16,223 | 100.0 | 100.0 |

- * SEER Data (Fast Stats), US estimated prevalence counts on 1/1/2003.