U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiologic Health (CDRH)
Office of the Commissioner (OC)
(PDF version of this document)
September 2005
Clinical Medical
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http://www.fda.gov/cber/guidelines.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiologic Health (CDRH)
Office of the Commissioner (OC)
September 2005
Clinical Medical
This guidance represents the Food and
Drug Administration's (FDA's) current thinking on this
topic. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the
public. An alternative approach may be used if such
approach satisfies the requirements of the applicable
statutes and regulations. |
This
guidance recommends using a standardized approach for collecting
and reporting race and ethnicity information in clinical trials
conducted in the United States and abroad for certain FDA
regulated products. The recommended standardized approach was
developed by the Office of Management and Budget (OMB). The
guidance lists the OMB categories for race and ethnicity and
describes FDA's reasons for recommending the use of these
categories. In addition, this guidance recommends a format for
race
and ethnicity data within study data that are submitted in
standardized data sets such as the Study Data Tabulation Model
or in the electronic Common Technical Document (eCTD).
This
document is intended to provide guidance on meeting the
requirements set forth in the 1998 final rule on investigational
new drug (IND) applications and new drug applications (NDAs)
(Demographic Rule). The Demographic Rule requires IND holders
to tabulate in their annual report the number of subjects
enrolled in clinical studies of drugs and biologic products by
age, race, and gender, and sponsors of NDAs to include summaries
of effectiveness and safety data for important demographic
subgroups, including racial subgroups.
This guidance is also intended to help applicants in preparing
biologics license applications (BLAs).
Although the regulations
governing medical devices do not include requirements for the
collection of demographic data comparable to those for INDs and
NDAs, for those cases in which race and ethnicity data are
relevant to determining the safety and effectiveness of a
device, FDA encourages sponsors to collect the data in
accordance with the OMB recommendations and the information
collection standards discussed in this guidance document.
Sponsors are also encouraged to discuss any race or ethnicity
issues with the appropriate review division in the Office of
Device Evaluation, Center for Devices and Radiological Health,
when developing their study protocols.
This
guidance does not address the level of participation of racial
and ethnic groups in clinical trials. For questions related to
the level of participation or the size of a study sponsors
should consult with the review division prior to the start of a
study.
FDA's
guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances
describe the Agency's current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or
statutory requirements are cited. The use of the word should
in Agency guidances means that something is suggested or
recommended, but not required.
FDA
regulations require sponsors of NDAs to present a summary of
safety and effectiveness data by demographic subgroups (age,
gender, race), as well as an analysis of whether modifications
of dose or dosage intervals are needed for specific subgroups
(21 CFR 314.50 (d)(5)(v)
and (vi)(a)).
One consideration in such summaries is the identification of a
subject’s race or ethnicity.
In
1997, OMB issued its revised recommendations for the collection
and use of race and ethnicity data by Federal agencies (Policy
Directive 15).
FDA is now recommending the use
of the standardized OMB race and ethnicity categories for data
collection in clinical trials for two reasons. First, the use
of the recommended OMB categories will help ensure consistency
in demographic subset analyses in applications submitted to FDA
(21 CFR 314.50(d)(5)(v) and (vi)(a),
312.120, 314.106(b), and 601.2) and in data collected by other
government agencies. Second, consistency in these categories
may make the demographic subset analysis more
useful in evaluating potential differences in the safety and
efficacy of pharmaceutical products among population subgroups.
To assess potential subgroup differences in a meaningful way, it
is important to use uniform, standard methods of defining racial
and ethnic subgroups.
Differences in response to medical products have already been
observed in racially and ethnically distinct subgroups of the
U.S. population.
These differences may be attributable to intrinsic factors
(e.g., genetics, metabolism, elimination), extrinsic factors
(e.g., diet, environmental exposure, sociocultural issues), or
interactions between these factors. For example, in the United
States, Whites
are more likely than persons of Asian and African heritage to
have abnormally low levels of an important enzyme (CYP2D6) that
metabolizes drugs belonging to a variety of therapeutic areas,
such as antidepressants, antipsychotics, and beta blockers (Xie
2001). Other studies have shown that Blacks respond poorly to
several classes of antihypertensive agents (beta blockers and
angiotensin converting enzyme (ACE) inhibitors) (Exner 2001 and
Yancy 2001). Racial
differences in skin structure and physiology that can affect
response to dermatologic and topically applied products have
been noted (Taylor 2002). Clinical trials have
demonstrated lower responses to interferon-alpha used in the
treatment of hepatitis C among Blacks when compared with other
racial subgroups (McHutchison 2000 and Reddy 1999).
B. FDA Decision to
Recommend Use of the OMB Categories
The OMB stated that its race and ethnicity categories were not
anthropologic or scientifically based designations, but instead
were categories that described the sociocultural construct of
our society. The Department of Health and Human Services (HHS)
chose to adopt these standardized categories for its agencies
that report statistics because the categories are relevant to
assessing various health related data, including public health
surveillance and research. FDA believes that the use of the
current OMB categories and any future revisions will facilitate
comparisons across clinical studies analyzed by FDA and data
collected by other agencies. Collection of data using standard
categories can enhance patient safety by helping FDA evaluate
potential differences in drug response among subpopulations.
Using standard categories may also facilitate analyses seeking
to identify differences in response.
Although FDA has long requested race and ethnicity data on
subjects in certain clinical trials, the Agency has not
previously made explicit recommendations on the categories to
use when collecting and reporting the data. In 1998, the Agency
issued the Demographic Rule, which reflected growing recognition
within the Agency and the health community that (1) different
subgroups of the population may respond differently to specific
drug products, and (2) although an effort should be made to look
for differences in effectiveness and adverse reactions among
such subgroups, that effort is not being made consistently.
In the Demographic Rule, FDA discussed the importance of
collecting data in clinical trials (and of presenting those data
in applications to the Agency) on population subgroups organized
by gender, race, age, and other relevant categories. The Agency
recommended that sponsors ask subjects in certain clinical
trials to identify their racial group and, if desired, that
sponsors use OMB categories when collecting race and ethnicity
data.
During the past two decades, efforts have been under way in a
number of Federal organizations to collect race and ethnicity
data in Federal programs in a standardized way. (See Appendix 1
for a summary of those efforts). In 1997, HHS issued a document
entitled Policy Statement on Inclusion of Race and Ethnicity
in DHHS Data Collection Activities.
In this policy statement, HHS adopted the
revised OMB categories for including race and ethnicity in HHS
funded and sponsored data collection and reporting systems. The
HHS policy states that the categories described in revised OMB
Directive 15 and its future revisions should be used when
collecting and reporting data in HHS data systems or reporting
HHS funded statistics.
The
Agency recommends that sponsors use the categories outlined in
this guidance when collecting race and ethnicity data in
clinical studies for FDA-regulated products conducted in United
States and abroad. More detailed race and ethnicity data can be
collected when appropriate to the study or locale, but we
recommend that these more detailed race and ethnicity data be
related to the identified OMB categories of all clinical trial
participants when submitting such data to the Agency.
The
recommendations in this section reflect the Agency's interest in
more consistent data collection. For studies conducted in the
United States, the Agency recommends that a two-question format
be used, and that trial participants self-report their racial
and ethnic ancestral origins. Based on the current OMB
Directive, the Agency provides the following recommendations for
the collection of the data:
1. We
recommend using the two-question format for requesting race and
ethnicity information, with the ethnicity question preceding the
question about race.
2. We
recommend that study participants self-report race and ethnicity
information whenever feasible, and that individuals be permitted
to designate a multiracial identity. When the collection of
self-reported designations is not feasible (e.g., because of the
subject’s inability to respond), we recommend that the
information be requested from a first-degree relative or other
knowledgeable source.
3. For ethnicity,
we recommend the following minimum choices be offered:
·
Hispanic or Latino
·
Not Hispanic or Latino
4. When
race and ethnicity information is collected separately, we
recommend the following minimum choices be offered for race:
·
American Indian or Alaska Native
·
Asian
·
Black or African American
·
Native Hawaiian or Other Pacific Islander
·
White
5. In
certain situations, as recommended in OMB Directive 15, more
detailed race and ethnicity information may be desired (e.g.,
White can reflect origins in Europe, the Middle East, or
North Africa; Asian can reflect origins from areas
ranging from India to Japan). If more detailed
characterizations of race or ethnicity are collected to enhance
data consistency, we recommend these characterizations be
traceable to the five minimum designations for race and two
designations for ethnicity (five and two) listed in numbers 3
and 4. When more detailed characterizations are desired, the
use of Race and Ethnicity vocabulary tables located within
Health Level Seven’s
Reference Information Model Structural Vocabulary Tables is
recommended. These tables provide the OMB characterizations
traceable to more detailed characterizations and concept ID code
sets to help ensure that traceability is consistent. Where gaps
exist in the representation of race or ethnicity categories, sponsors
are encouraged to discuss the race or ethnicity issue with the
appropriate review division.
To assist in assessing the relevance of
foreign study population data to U.S. populations, we recommend
that sponsors use the OMB standardized categories when
collecting data from study participants in clinical trials
conducted outside of the United States. However, FDA recognizes
that the recommended categories for race and ethnicity were
developed in the United States and that these categories may not
adequately describe racial and ethnic groups in foreign
countries. Therefore, for studies conducted outside the United
States, we recommend using more detailed categories to provide
sponsors the flexibility to adequately characterize race and
ethnicity. If sponsors choose to use more detailed
characterizations of race and ethnicity, it is important for
analytical purposes that the data can be traced back to the
recommended categories described below. When more detailed
characterizations are desired, the use of the Race and Ethnicity
vocabulary tables located within Health Level Seven’s Reference
Information Model Structural Vocabulary Tables is
recommended[1]These tables provide the five and two OMB
characterizations traceable to more detailed characterizations
and concept ID code sets and their use will help ensure that
traceability is consistent. Where gaps exist in the
representation of race or ethnicity categories,
sponsors are encouraged to
discuss the issue with the appropriate review division.
-
Hispanic or Latino
-
Not Hispanic or Latino
When race is collected separately in clinical studies conducted
in foreign countries, we recommend that the categories be
modified to reflect the following, as appropriate:
Note that the ethnic and racial categories for studies inside
and outside the United States are the same, except for one
racial designation: the racial designation is African American
in the United States, whereas it is Black for studies conducted
in foreign countries.
For
INDs, NDAs, BLAs and relevant device submissions we recommend
the submission of tabulated demographic data based on the
Demographic Rule for all clinical studies using the
characterizations of race and ethnicity described in this
guidance.
For
submitting an electronic application not in FDA's typical
application format (i.e., when using the ICH document for
submitting a marketing application to FDA and regulatory
agencies in Japan and Europe, the eCTD) presentation of
demographic data is described in ICH M4E eCTD Guidance (section
2.7.4.1.3 and table 2.7.4.2), which suggests a tabular display
of demographic characteristics (e.g., age, gender, race) by
treatment group (e.g., active drug, placebo). The document
suggests specific kinds of demographic information to be
collected as a part of a clinical trial, but does not provide
rigid specifications on how the data should be presented,
noting, for example, that “if relative exposure of demographic
groups in the controlled trials differ from the overall
exposure, it may be useful to provide separate tables.” Choices
of how best to summarize demographic data depend on the nature
of the data to be conveyed. For some trials, it may be useful
to show the distribution of one demographic characteristic
within a second demographic (e.g., the age distribution of men
and women enrolled in a set of controlled trials).
With
regard to the description of race and ethnicity, the categories
that are suggested previously in this document (sections III and
IV) are preferable to those suggested in ICH M4E eCTD guidance.
For
more than 20 years, a number of U.S. Government initiatives have
tried to address questions related to whether to and how to
collect race and ethnicity data. Major initiatives are reviewed
briefly here.
Office of Management and Budget (OMB) Initiatives
In
May 1977, OMB issued “Statistical Policy Directive No. 15, Race
and Ethnic Standards for Federal Statistics and Administrative
Reporting.” The standards were developed in response to the
need to enforce civil rights laws in education. These
classifications were not to be interpreted as being scientific
or anthropological in nature, or to be viewed as determinants of
eligibility for participation in any Federal program. They were
developed in response to needs expressed by both the Executive
Branch and the Congress to provide for the collection and use of
compatible, nonduplicated, exchangeable race and ethnicity data
by Federal agencies. This Directive specified four categories
for race:
·
American Indian or Alaskan Native
·
Asian or Pacific Islander
·
Black
·
White
And
two categories for ethnicity:
·
Hispanic
·
Not of Hispanic origin
The
OMB Directive specified two questionnaire formats for data
collection: (1) a format combining race and ethnicity, and (2)
a preferred format with two separate questions for race and
ethnicity.
Since
1993, efforts have been under way to standardize the collection
of race and ethnicity data to foster comparability across data
collection and reporting systems. In 1997, OMB published
Directive 15, “Revisions
to the Standards for
the Classification of Federal Data on Race and Ethnicity” (see
Appendix 2). These revisions specified the
minimum racial and ethnic diversity categories to be used when
race and ethnicity are included in data collection and reporting
for Federal programs. The Directive does not require that race
and ethnicity be included in data
collection and reporting; rather, it specifies what formats and
categories to use when collecting this kind of data.
The
revised OMB standards made the following changes:
·
Introduced the option of reporting more than one
race for multiracial persons
·
Divided the Asian or Pacific Islander category
into two — one labeled Asian, the other Native Hawaiian or Other
Pacific Islander
·
Changed Hispanic to Hispanic or Latino
·
Changed Black to Black or African-American
·
Strongly encouraged the use of self-identification
·
Maintained the two-question format for race and
Hispanic ethnicity when self-identification is used (the
Hispanic origin question should precede the race question)
The
revised categories were described in an OMB guidance entitled
Implementation of the 1997 Standards for Federal Data on Race
and Ethnicity (2000) as sociopolitical and intended for use
in the collection of health data, among other types of
statistics.
Department of Health and Human Services Initiatives
In
1999, the Department of Health and Human Services (HHS) issued a
report, Improving
the Collection and Use of Racial and Ethnic Data in HHS.
The report describes HHS policy on collecting and reporting data
on race and ethnicity for HHS programs. The report asks for the
inclusion of race and ethnicity categories in HHS funded and
sponsored data collection and reporting systems in all HHS
programs, including in both health and human services. This
policy clearly states that the minimum standard categories in
OMB Directive 15 and revisions should be used when collecting
and reporting data in HHS data systems or reporting HHS funded
statistics. The policy was developed to (1) help monitor HHS
programs, (2) determine whether Federal funds are being used in
a nondiscriminatory manner, and (3) promote the availability of
standard race and ethnicity data across various agencies to
facilitate HHS responses to major health and human services
issues.
National Institutes of Health Initiatives
In
1993, the National Institutes of Health (NIH) Revitalization Act
directed NIH to establish guidelines for including women and
minorities in NIH-sponsored clinical research. NIH was directed
to ensure that women and minorities were included as subjects,
unless their exclusion was justified due to circumstances
specified by NIH guidelines. Furthermore, clinical trials were
to be designed and carried out in a manner that would elicit
information about individuals of both genders and diverse racial
and ethnic groups to examine differential effects on such
groups. NIH guidelines stipulate that when proposing a Phase 3
clinical trial, evidence must be reviewed to establish whether
or not there are potentially clinically important gender- and
minority-based differences in the anticipated effects of the
intervention. If previous studies support the existence of
significant differences, the primary questions and design of the
study must specifically accommodate this. For example, if men
and women are thought to respond differently to an intervention,
then the Phase 3 clinical trial must be designed to answer two
separate primary questions, one for men, and the other for
women. When prior studies support no significant differences
for either gender or minorities with a given intervention, then
gender and minority status will not be required as subject
selection criteria, although the inclusion and analysis of both
genders and minorities is strongly encouraged. When prior
studies neither support nor negate significant differences, then
the design of the Phase 3 clinical trial will be required to
support sufficient representation of both genders and minorities
to allow for valid analysis of the intervention effects across
all groups. However, the trial will not be required to provide
high statistical power for these comparisons.
Food and Drug
Administration Initiatives
Beginning in the
1980s, FDA grew concerned about possible differences in drug
safety and efficacy among different population subgroups.
Because the origins of subpopulation issues stem from the
identification of differences in response in women and geriatric
populations, references to those initiatives are included
below. In 1983, the
Agency initiated development of guidance on the study of drugs
to be used in geriatric patients. FDA's Guideline for the
Study of Drugs Likely to be Used in the Elderly was issued
in 1989.
The first regulation specifying
the analysis of population subsets appeared in 1985 in 21 CFR
314.50, which called for evidence to support the “dosage and
administration section of the labeling, including support for
the dosage and dose interval recommended,” and modifications for
specific subgroups (e.g., pediatrics, geriatrics, patients with
renal failure) (21 CFR 314.50(d)(5)(v)).
In 1988, the
Agency issued guidance describing elements of a new drug
application's analysis of clinical study data.
Guideline for
the Format and Content of the Clinical and Statistical Sections
of New Drug Applications emphasized the
importance of conducting subset analyses on data from clinical
studies submitted in new drug applications (NDAs). This
guidance specified race and ethnicity as types of population
subsets for which separate analyses of data from clinical
studies should be conducted for assessments of product safety
and effectiveness.
In July 1993, FDA
published a guidance on the study of drugs in both genders
entitled Guideline for the Study and Evaluation of Gender
Differences in the Clinical Evaluation of Drugs. The
guidance specifically called for analyzing trials by gender and
for evaluating pharmacokinetics in women. In the Federal
Register notice announcing the guidance, FDA also abandoned
the policy explained in a 1977 guidance, excluding women of
childbearing potential from participation in the earliest phases
of clinical trials.
In 1993, FDA also
published New Drug Evaluation Guidance Document: Refusal to
File, on the Agency's use of the refusal-to-file (RTF)
option if certain analyses were not performed. The guidance
states that the Agency can exercise its RTF authority under 21
CFR 314.101(d)(3) if there is “inadequate evaluation for safety
and/or effectiveness of the population intended to use the drug,
including pertinent subsets, such as gender, age, and racial
subsets.”
In the Food and
Drug Administration Modernization Act of 1997 (the
Modernization Act), Congress directed FDA to examine issues
related to the inclusion of racial and ethnic groups in clinical
trials of new drugs. Section 115(b) of the Modernization Act
required the Secretary, “in consultation with the Director of
the National Institutes of Health and with representatives of
the drug manufacturing industry, [to] review and develop
guidance, as appropriate, on the inclusion of women and
minorities in clinical trials. . . .” (codified at 21 U.S.C.
355(b)(1)). In response, FDA established the Women and
Minorities Working Group to review and implement this section of
the Modernization Act. In a report issued on July 20, 1998, the
Working Group concluded that the Agency would implement
procedures to enhance its ability to gather and evaluate
demographic data, and then decide whether additional guidance
should be developed in the future.
In 1998, the
Agency published the Demographic Rule, which amended the
language in 21 CFR 312.33(a)(2) and 314.50(d)(5), requiring
sponsors to (1) tabulate the numbers of participants in clinical
trials by age group, gender, and race in investigational new
drug application (IND) annual reports, (2) characterize the data
in NDAs according to these same subgroups, and (3) when
appropriate, present safety data from other subgroups of the
population of patients, such as for patients with hepatic or
renal failure or patients with different levels of severity of
the disease.
In 1999, a
guidance for industry entitled
Population Pharmacokinetics made recommendations
on the use of population pharmacokinetics in the drug
development process to help identify differences in drug safety
and efficacy among population subgroups, including race and
ethnicity. This guidance recommended that industry conduct
clinical studies in subjects representative of the population to
be treated with the drug.
In 2002, the Best
Pharmaceuticals for Children Act (Public Law 107-109, January 4,
2002) directed FDA to monitor the racial and ethnic designations
of children participating in clinical studies for pharmaceutical
products.
ICH E5 - Guidance on Ethnic Factors in the Acceptability of
Foreign Clinical Data
In
1999, as part of an international effort by Japan, the European
Union, and the United States to harmonize technical requirements
for pharmaceutical drug development and regulation (the
International Conference on Harmonization (ICH)), the FDA
published a guidance entitled E5 Guidance on Ethnic Factors
in the Acceptability of Foreign Clinical Data
(63 FR 31790, June 10,
1999), to permit the
clinical data collected in one region to be used in the
registration or approval of a drug or biological product in
another region, while allowing for the influence of ethnic
factors. The E5 guidance defines ethnic factors that
affect response in terms of both intrinsic and extrinsic
issues. Because differences in ethnic factors have the
potential to affect responses in some subpopulations, the E5
guidance provides a general framework for evaluating
medicines with regard to their sensitivity to ethnic factors.
OMB Standards for Maintaining,
Collecting, and Presenting
Federal Data on Race and
Ethnicity
(Adopted on October
30, 1997)
This
classification provides a minimum standard for maintaining,
collecting, and presenting data on race and ethnicity for all
Federal reporting purposes. The categories in this
classification are social-political constructs and should not be
interpreted as being scientific or anthropological in nature.
They are not to be used as determinants of eligibility for
participation in any Federal program. The standards have been
developed to provide a common language for uniformity and
comparability in the collection and use of data on race and
ethnicity by Federal agencies.
The
standards have five categories for data on race: American
Indian or Alaska Native, Asian, Black or African American,
Native Hawaiian or Other Pacific Islander, and White. There are
two categories for data on ethnicity: Hispanic or Latino, and
Not Hispanic or Latino.
1.
Categories and Definitions
The
minimum categories for data on race and ethnicity for Federal
statistics, program administrative reporting, and civil rights
compliance reporting are defined as follows:
American Indian or Alaska Native.
A person having origins in any of the original peoples of North
and South America (including Central America), and who maintains
tribal affiliation or community attachment.
Asian. A person
having origins in any of the original peoples of the Far East,
Southeast Asia, or the Indian subcontinent, including, for
example, Cambodia, China, India, Japan, Korea, Malaysia,
Pakistan, the Philippine Islands, Thailand, and Vietnam.
Black or African American.
A person having origins in any of the black
racial groups of Africa. Terms such as “Haitian” or
“Negro” can be used in addition to “Black or African American.”
Hispanic or Latino.
A person of Cuban, Mexican, Puerto Rican,
South or Central American, or other Spanish culture or origin,
regardless of race. The term, “Spanish origin,” can be
used in addition to “Hispanic or Latino.”
Native Hawaiian or Other Pacific
Islander. A person having
origins in any of the original peoples of Hawaii, Guam, Samoa,
or other Pacific Islands.
White.
A person having origins in any of the
original peoples of Europe, the Middle East, or North Africa.
Respondents shall be offered the option of selecting one or more
racial designations. Recommended forms for the instruction
accompanying the multiple response question
are “Mark one or more” and “Select one or more.”
2.
Data Formats
The
standards provide two formats that may be used for data on race
and ethnicity. Self-reporting or self-identification using two
separate questions is the preferred method for collecting data
on race and ethnicity. In situations where self-reporting is
not practicable or feasible, the combined format may be used.
In no
case shall the provisions of the standards be construed to limit
the collection of data to the categories described above. The
collection of greater detail is encouraged; however, any
collection that uses more detail shall be organized in such a
way that the additional categories can be aggregated into these
minimum categories for data on race and ethnicity.
With
respect to tabulation, the procedures used by Federal agencies
shall result in the production of as much detailed information
on race and ethnicity as possible. However, Federal agencies
shall not present data on detailed categories if doing so would
compromise data quality or confidentiality standards.
a.
Two-question format
To
provide flexibility and ensure data quality, separate questions
shall be used wherever feasible for reporting race and
ethnicity. When race and ethnicity are collected separately,
ethnicity shall be collected first. If race and ethnicity are
collected separately, the minimum designations are:
Race:
American Indian or Alaska Native
Asian
Black
or African American
Native Hawaiian or Other Pacific Islander
White
Ethnicity:
Hispanic or Latino
Not
Hispanic or Latino
When
data on race and ethnicity are collected separately, provision
shall be made to report the number of respondents in each racial
category who are Hispanic or Latino. When aggregate data are
presented, data producers shall provide the number of
respondents who marked (or selected) only one category,
separately for each of the five racial categories. In addition
to these numbers, data producers are strongly encouraged to
provide the detailed distributions, including all possible
combinations of multiple responses to the race question. If
data on multiple responses are collapsed, at a minimum the total
number of respondents reporting “more than one race” shall be
made available.
b.
Combined format
The
combined format may be used, if necessary, for
observer-collected data on race and ethnicity. Both race
(including multiple responses) and ethnicity shall be collected
when appropriate and feasible, although the selection of one
category in the combined format is acceptable. If a combined
format is used, there are six minimum categories:
American Indian or Alaska Native
Asian
Black
or African American
Hispanic or Latino
Native Hawaiian or Other Pacific Islander
White
When
aggregate data are presented, data producers shall provide the
number of respondents who marked (or selected) only one
category, separately for each of the six categories. In
addition to these numbers, data producers are strongly
encouraged to provide the detailed distributions, including all
possible combinations of multiple responses. In cases where
data on multiple responses are collapsed, the total number of
respondents reporting “Hispanic or Latino and one or more races”
and the total number of respondents reporting “more than one
race” (regardless of ethnicity) shall be provided.
3.
Use of the Standards for Record Keeping and
Reporting
The
minimum standard categories shall be used for reporting as
follows:
a.
Statistical reporting
These
standards shall be used at a minimum for all federally sponsored
statistical data collections that include data on race and/or
ethnicity, except when the collection involves a sample of such
size that the data on the smaller categories would be
unreliable, or when the collection effort focuses on a specific
racial or ethnic group. Any other variation will have to be
specifically authorized by the OMB through the information
collection clearance process. In those cases where the data
collection is not subject to the information collection
clearance process, a direct request for a variance shall be made
to OMB.
b.
General program administrative and grant reporting
These
standards shall be used for all Federal administrative reporting
or record keeping requirements that include data on race and
ethnicity. Agencies that cannot follow these standards must
request a variance from OMB. Variances will be considered if
the agency can demonstrate that it is not reasonable for the
primary reporter to determine racial or ethnic background in
terms of the specified categories, that determination of racial
or ethnic background is not critical to the administration of
the program in question, or that the specific program is
directed to only one or a limited number of racial or ethnic
groups.
c.
Civil rights and other compliance reporting
These
standards shall be used by all Federal agencies in
either the separate or combined format for
civil rights and other compliance reporting from the
public and private sectors and all levels of government. Any
variation requiring less detailed data or data which cannot be
aggregated into the basic categories must be specifically
approved by OMB for executive agencies. More detailed reporting
which can be aggregated to the basic categories may be used at
the agencies' discretion.
4.
Presentation of Data on Race and Ethnicity
Displays of statistical, administrative,
and compliance data on race and ethnicity shall use the
categories listed above. The term “nonwhite” is not acceptable
for use in the presentation of Federal Government data. It
shall not be used in any publication or in the text of any
report. In cases where the standard categories are considered
inappropriate for presentation of data on particular programs or
for particular regional areas, the sponsoring agency may use:
a.
The designations “Black or African American and Other Races” or
“All Other Races” as collective descriptions of minority races
when the most summary distinction between the majority and
minority races is appropriate;
b.
The designations “White,” “Black or African American,” and “All
Other Races” when the distinction among the majority race, the
principal minority race, and other races is appropriate; or
c.
The designation of a particular minority race or races, and
the inclusion of “Whites” with “All Other Races” when such a
collective description is appropriate. In displaying detailed
information that represents a combination of race and ethnicity,
the description of the data being displayed shall clearly
indicate that both bases of classification are being used.
When
the primary focus of a report is on two or more specific
identifiable groups in the population, one or more of which is
racial or ethnic, it is acceptable to display data for each of
the particular groups separately and to describe data relating
to the remainder of the population by an appropriate collective
description.
5.
Effective Date
The
provisions of these standards are effective immediately for
all new
and revised
record keeping or reporting requirements that include racial
and/or ethnic information. All
existing
record keeping or reporting requirements shall be made
consistent with these standards at the time they are submitted
for extension, or not later than January 1, 2003.
Exner, D., D. Dries, M.
Donamski, and J. Cohn, 2001, “Lesser Response to Angiotensin-Converting-Enzyme
Inhibitor Therapy in Black as Compared with White Patients
With Left Ventricular Dysfunction,” N Engl J Med, 344:
1351-1357.
Freedman, L.S., R.M. Simon,
M.A. Foulkes, L.M. Freedman, N.L. Gordon, et al., 1995,
“Inclusion of Women and Minorities in Clinical Trials and the
NIH Revitalization Act — the Perspective of NIH Clinical
Trialists,” Control Clin Trials, 16(5):277-285,
310-312.
McHutchison, J., T. Poynard, S. Pianko, S. Gordon, A. Reid, et
al., 2000, “The Impact of Interferon Alpha
Plus Ribavirin on Response to Therapy in Black Patients
with Chronic Hepatitis C. The International Hepatitis
Interventional Therapy Group,” Gastroenterology, 119:
1317-23.
Reddy, K. R., J. Hoofnagle, M. Tong, W. Lee, P. Pockros, et
al., 1999, “Racial Differences in Responses to Therapy with
Interferon in Chronic Hepatitis C. Consensus Interferon Study
Group,” Hepatology, 30: 787-93.
Taylor, S., 2002, “Skin of Color: Biology, Structure,
Function, and Implications for Dermatologic Disease,”
Journal of
American Academy of Dermatology,
46:S41-62.
Xie, H., R. Kim, A. Wood, and
C. Stein, 2001, “Molecular Basis of Ethnic Differences in Drug
Disposition and Response,” Annu Rev Pharmacol Toxicol,
41:815-50.
Yancy, C., M. Fowler, W.
Colucci, E. Gilbert, M. Bristow, et al., 2001, “Race and the
Response to Adrenergic Blockade with Carvedilol in Patients
with Chronic Heart Failure,” N Engl J Med, 344:
1358-1365.
DHHS
Policy and Reports
Department of Health and Human Services (DHHS), 1997,
Policy For Improving Race and
Ethnicity Data, October 24, 1997,
http://www.hhs.gov/oirm/infocollect/nclusion.html.
DHHS, 1999,
Improving the Collection and Use of Racial and Ethnic Data in
HHS, joint report of the HHS Data Council Working Group on
Racial and Ethnic Data and the Data Work Group of the HHS
Initiative to Eliminate Racial and Ethnic Disparities in
Health, December 1999,
http://aspe.hhs.gov/datacncl/racerpt/index.htm.
FDA
Regulations
Food and
Drug Administration (FDA), 1998, “Investigational New Drug
Applications and New Drug Applications,” Final Rule,
Federal Register (63 FR 6854, February 11, 1998).
FDA, Content and Format for Human Prescription Drugs;
Addition of “Geriatric Use” Subsection in the Labeling,
Final Rule, Federal Register (62 FR 45313, August 27,
1997).
FDA Guidance for Industry
Clinical Studies Section of Labeling for Prescription Drugs
and Biologics (Draft)
Content and Format for Geriatric Labeling
Content and Format of the Adverse Reactions Section of
Labeling for Human Prescription Drugs and Biologics (Draft)
General Considerations for Pediatric Pharmacokinetic Studies
for Drugs and Biological Products (Draft)
General Considerations for the Clinical Evaluation of Drugs
Format and Content of the Clinical and Statistical Sections
of an Application
Study and Evaluation of Gender Differences in the Clinical
Evaluation of Drugs
Study of Drugs Likely to be Used in the Elderly
In Vivo Drug Metabolism/Drug Interaction Studies — Study
Design, Data Analysis, and Recommendations for Dosing and
Labeling
Pharmacokinetics in Patients with Impaired Hepatic Function:
Study Design, Data Analysis, and Impact on Dosing and Labeling
Pharmacokinetics in Patients with Impaired Renal Function:
Study Design, Data Analysis and Impact on Dosing and Labeling
Population Pharmacokinetics
Refusal to File
ICH Guidances
ICH, E4 Dose Response Information to Support Drug
Registration
ICH, E5 Ethnic Factors in the Acceptability
Of Foreign Data
ICH, E7 Studies in Support of Special Populations:
Geriatrics
ICH, E11 Clinical Investigation of Medicinal Products in the
Pediatric Population
ICH, M4
Common Technical Document for the Registration of
Pharmaceuticals for Human Use
Other
Sources
Office of Management and Budget, 1994,
Standards for the Classification of Federal Data on Race and
Ethnicity,
http://www.whitehouse.gov/omb/fedreg/notice_15.html.
General
Accounting Office, FDA Needs to Ensure More Study of Gender
Differences in Prescription Drug Testing, GAO/HFD-93-17.
NIH Revitalization Act of 1993, (PL 103-43).
NIH
Guidelines on the Inclusion of Women and Minorities as Subjects
in Clinical Research- Updated August 1, 2000.
Available at
http://grants.nih.gov/grants/funding/women_min/women_min.htm.
Food and Drug Administration Modernization Act of 1997 (Public
Law 105-115).
Best
Pharmaceuticals Act for Children of 2002 (Public Law 107-109).