January 23, 2015
The Honorable Margaret Hamburg, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: [Docket No. FDA--2014-N-1818] Comments on FDA Drug Trials Snapshots
Dear Dr. Hamburg:
We applaud FDA’s efforts to develop the Drug Trials Snapshot (the Snapshot) to provide the
public with crucial safety and efficacy information on clinical trials. We are also pleased that the
FDA has developed a format that is user-friendly and straightforward allowing consumers and
other stakeholders to review clinical trial information in one centralized location. However,
although we believe the Snapshot is an important and welcome step on the path to transparency
and health equity in biomedical research, we believe the site could be more comprehensive and
accessible for consumers. Therefore, we respectfully submit the following recommendations.
Report Proportions of Women, Minorities and Elderly in all Trial Phases
The Snapshot should report on the representative inclusion of subgroups and report on inclusion
of subgroups of women, minorities and the elderly in all phases of clinical trials including Phase
I and II clinical trials. The Snapshot focuses mainly on Phase III clinical trials, leaving out
important phases of the medical product development process.
Report Data Retrospectively
The Snapshot should include retrospective data, prior to 2014, to provide the public with safety
and effectiveness data on approved medical products. Although the inclusion of retrospective
data may take considerable time and resources, the current safety and efficacy of FDA-approved
medical products cannot be assured for millions of Americans in subgroups historically
underrepresented in clinical trials. We believe the resources expended to undertake this
retrospective analysis and availability of data will pay enormous dividends over the long-term by
allowing key subgroups of patients, and the providers who care for them, information crucial to
informed decision-making related to the safety and efficacy of current medical products.
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Allow Access to Searchable Cross-Referenced Subgroup Inclusion and Outcome Data
The Snapshot should present data in a format that allows the public to access cross-referenced
outcome and inclusion subgroup data to determine the impact the intersection of sex, race,
ethnicity, and age have efficacy, safety, and adverse events. For example, subgroups on sex
should be easily cross-referenced with subgroup data on race/ethnicity to determine how many
women by race and age are included in a specific drug’s clinical trials while outcome data and
analysis should be reported to determine the outcomes and adverse events for all subgroups of
women for a specific medical product. Other issues to address associated with data on subgroups
include:
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Limited number of patients in the non-white subgroups means that differences among
sexes, races, ethnicities, and/or ages in response to a drug may not have been able to be
detected.
Although women make up more than half the overall populations, less than half of the
patients in clinical trials were female.
Lack of transparency on ethnicity. For some drugs, ethnicity was available when the user
clicked on the “More Information” button at the bottom of the page but not in every case.
Ethnicity should be included for all clinical trials, be included for subgroup analysis and
it should be included on the main page rather than in a separate page.
The “Other” categories should be broken down to demonstrate what race/ethnicity groups
are included.
To address this concern about access to information on inclusion in clinical studies, we urge the
development of a searchable dataset that can be searched based on specific variables (sex, race,
ethnicity, age categories) for each approved medical product. A model for this could be Quick
Health Data Online, a data system created by HHS Office on Women’s Health that, though very
different from FDA clinical studies data, combines multiple datasets and allows for easy use by
the public. Such a system would reduce the need for FDA staff to generate results for all
possible combinations, but allow for the public to query the data for specific subpopulation
inclusion in studies.
Outcome data also needs to include multiple subgroup analyses on differences in adverse events
and efficacy which are currently not evaluated by simultaneously by sex, race, or age.
Report Data for Preclinical Studies
Inclusion data should also be publicly available for all phases of studies, including animal
studies, and not be limited to human studies. Therefore, the Snapshot should be expanded include
information on all preclinical research, where applicable, to demonstrate the inclusion of female
research animals and reporting of the sex of the animals in preclinical research. The National
Institutes of Health (NIH) acknowledged the importance of including female research animals in
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preclinical research with its recent policies aimed at requiring applicants to report their plans for
balancing the inclusion of male and female cells and animals in preclinical studies. Given the
complementary missions of the NIH and the FDA, a parallel requirement by FDA is essential to
ensure a comprehensive approach to ending inequities in biomedical research. Too often,
important research fails to identify important sex differences at the cellular and animal levels,
limiting its value. The lack of sex-based animal studies, typically in early stages of research and
development, perpetuates the gap down the road.
Improve Accessibility
To maximize the impact and use of this important Snapshot tool, we urge the FDA to make this
information more accessible by providing a link to the Snapshot on FDA main web pages and
making the information available in languages other than English.
Sincerely,
Paula A. Johnson, MD, MPH
Executive Director, Connors Center for Women's Health and Gender Biology
Chief, Division of Women's Health
Professor of Medicine, Harvard Medical School
Professor of Epidemiology, Harvard School of Public Health
Brigham and Women's Hospital
75 Francis Street; PB5
Boston, MA 02215
Susan F. Wood, PhD
Associate Professor
Department of Health Policy and Management
Director,
Jacobs Institute of Women's Health
The George Washington University
Milken Institute School of Public Health
Note: New Address
950 New Hampshire Ave, NW
Floor 2
Washington, DC 20052
Therese Fitzgerald, PhD, MSW
Director, Women's Health Policy & Advocacy Program
Connors Center for Women's Health and Gender Biology
Brigham & Women's Hospital
Division of Women's Health, OBC3-34
1620 Tremont Street
Boston, MA 02115
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