Resources

Advancing Clinical Research With Pregnant And Lactating Populations

National Academies

Summarizes legal, ethical, and regulatory barriers to including pregnant and lactating populations in clinical research and offers recommendations to improve their inclusion.

Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators

IMDRF

Provides information on the structure, fields, and use of a Common Data Set for international adverse event data exchange between medical device regulators.

ConcePTION data

IMI ConcePTION

Provides information on medicine safety during pregnancy and breastfeeding, offering research data, guidelines, and tools to support informed healthcare decisions for women and professionals.

Gender- and Sexual Orientation- Based Inequities: Promoting Inclusion, Visibility, and Data Accuracy in Oncology

Alpert, A. B. et al.

Summarizes barriers, disparities, and data gaps for sexual and gender minorities in oncology, recommending inclusive practices and comprehensive data collection to promote equity.

Guiding Principles To Support Medical Device Health Equity

IMDRF

Provides information on guiding principles to support health equity in medical device development, evaluation, and regulation for IMDRF working groups.

Integrating sex and gender into health and care research

NIHR

Provides information on integrating sex and gender into health and care research to improve outcomes and address research gaps and inequalities.

Is Sex as a Biological Variable Still Being Ignored in Preclinical Aging Research?

Carmody, C. et al.

Reviews adherence to NIH mandates on sex as a biological variable in preclinical aging research, identifying gaps and recommending strategies for improved compliance.

Making Pharmaceutical Research and Regulation Work for Women

Ravindran, T. S. et al.

Reviews gaps in sex and gender integration in pharmaceutical research, regulation, and policy to highlight the need for more equitable, evidence-based approaches for women.

Perinatal Medication Use: Considerations for Health Care Providers

CAMT

Provides information on medication use during pregnancy and lactation, counseling strategies, and key resources to support informed clinical decisions.

Sex and Gender Differences Research Design for Basic, Clinical, and Population Studies: Essentials for Investigators

Rich-Edwards, J. W. et al.

Summarizes key research design considerations for studying sex and gender differences to enhance scientific rigor in basic, clinical, and population research.

Sex And Gender In Research Involving Humans According To The HRA: Recommendations for the Ethical Review of Research Projects

Swissethics

Provides recommendations and practical guidelines for integrating sex and gender considerations in biomedical research protocols for ethical review purposes.

Statement on Sex, Gender, Variations of Sex Characteristics and Sexual Orientation in Health and Medical Research

NHMRC and the Department of Health and Aged Care

Provides information on best practices for considering sex, gender, sex characteristics, and sexual orientation in health research to improve inclusivity and data quality.

Studying Both Sexes: A Guiding Principle for Biomedicine

Clayton, J. A. 

Provides information on the rationale and goals of NIH policy requiring consideration of sex as a biological variable in preclinical biomedical research.

The Integration Of Sex and Gender Considerations Into Biomedical Research: Lessons From International Funding Agencies

White, J. et al.

Reviews policies, mechanisms, and resources from major international funding agencies for integrating sex and gender considerations into biomedical research to improve research quality and outcomes.

The state of gender inclusion in Asia-Pacific’s regulatory landscape

AVPN

Summarizes gender inclusion policies, challenges, and opportunities in Asia-Pacific’s regulatory landscape across education, workforce, politics, and healthcare for policy and impact analysis.

US Health Care Spending by Payer and Health Condition, 1996-2016

Dieleman J.L., et al. 

Summarizes US health care spending by payer and health condition from 1996–2016 to inform policy, including trends by age, sex, and type of care.

WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products

World Health Organization

Summarizes benchmarks, indicators, and guidance for evaluating and strengthening national medical product regulatory authorities for improved regulatory system performance.

Women’s Health Action Plan 2024-2025 Phase 2: An Evolution in Women’s Health

Ireland DOH

Summarizes key actions, achievements, and planned investments in Ireland’s women’s health services for 2024-2025 to guide policy and service development.