2025-06-02-世界经济论坛-变革处方_妇女健康研究的政策建议（英）_28页_24mb

报告摘要

Summary of Prescription for Change: Policy Recommendations for Women's Health Research

Core Content

This white paper, published by the World Economic Forum in May 2025, outlines key policy recommendations aimed at transforming women's health research. It emphasizes the need for innovation, inclusion, data transparency, and tailored clinical trial design to address the systemic underrepresentation and underfunding of women's health research.

Main Points

1. Women's Health is Underfunded and Under-Research

Women spend 25% more of their lives in poor health or with some degree of disability compared to men.
Only 7% of healthcare research focuses on conditions that exclusively affect women.
Only 5% of available medications are adequately tested and labeled for use in pregnant and breastfeeding women.
Sex-disaggregated data is rarely reported, with only 7% of migraine trials and 17% of ischaemic heart disease trials publishing such data.

2. Inclusion of Women in Clinical Trials

Women remain underrepresented in clinical trials, especially in early-stage research and key therapeutic areas such as cardiology and oncology.
Women of color and post-menopausal women are often excluded from trials.
A maternal investigation framework is proposed to ensure research includes pregnant and lactating women.
Awareness and training for regulators and trial staff are necessary to improve inclusion.

3. Disaggregation of Clinical Trial Data

Standardizing terminology and data collection is essential for better understanding of sex-specific effects.
Comprehensive sex-specific benefit-risk assessments should be required.
Flexible methodologies and global data sharing are recommended to maximize insights from limited datasets.

4. Designing Clinical Trials with Women in Mind

Clinical trials should be designed to account for sex-based differences in physiological mechanisms and treatment responses.
Education and training for investigators, developers, clinical trial staff, and patients are necessary to improve research quality and outcomes.
Access to clinical trials should be expanded, particularly for women from underserved communities.

5. Deepening Insights into Sex-Specific Differences

Clinical guidelines, product package inserts, and patient information leaflets should be updated to reflect sex differences.
Implementing the SAGER guidelines in scientific journals can improve transparency in reporting sex-specific differences.

Key Policy Recommendations

Focus Area	Policy Recommendation
Innovation	- Introduce regulatory incentives such as female disease designation and priority review vouchers.
	- Create financial incentives through grants, prizes, tax credits, and public-private partnerships.
	- Adopt new pricing and reimbursement value propositions, including price premiums and guaranteed payments.
Inclusion	- Expand the inclusion of women in clinical trials, especially in early-stage trials and key therapeutic areas.
	- Introduce a maternal investigation plan to ensure research includes pregnant and lactating women.
	- Raise awareness among regulators and investigators to generate more representative data.
Data	- Enhance the disaggregation of clinical trial data.
	- Standardize terminology and data collection.
	- Require comprehensive sex-specific benefit-risk assessments.
	- Adopt flexible methodologies and global data sharing.
Design	- Design clinical trials to account for sex-based differences in disease mechanisms and treatment responses.
	- Educate all stakeholders involved in clinical trials.
	- Ensure access to trials for women from underserved communities.
Insights	- Update clinical guidelines and product information to reflect sex-specific insights.
	- Implement the SAGER guidelines to improve transparency in reporting sex differences.

Economic and Health Impact

Addressing the women's health research gap could yield 75 million disability-adjusted life years annually and unlock $1 trillion in global GDP by 2040.
Improving women's health leads to better quality of life and has far-reaching economic benefits.
Current data suggests that women are more likely to experience adverse events from approved medicines, highlighting the urgent need for more inclusive and representative research.

Conclusion

The paper calls for a coordinated, multi-stakeholder approach to transform women's health research. It argues that prioritizing innovation and inclusion can break down barriers and lead to better health outcomes and stronger economies. The recommendations include regulatory, financial, and pricing strategies, as well as efforts to improve data transparency and trial design.

This white paper is a strategic roadmap to close the women's health research gap and advance sex-specific medicine, ensuring that women are not left behind in the pursuit of scientific and medical progress.

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