Table 2.

Recommendations to improve the evidence base for women with CVD [16]

1) Improve trial design
a) Power trials to test heterogeneity in outcomes by sex
b) Explore further such heterogeneity when identified
c) Form a statistics working group to develop alternative statistical methods
2) Better enrollment in trials
a) Increase use of proven recruitment and retention strategies
b) Research to understand sex-related differences in recruitment and retention of subjects and how to overcome them
c) Employ regulatory and reimbursement strategies
d) Better Centers for Medicare and Medicaid Services coverage of trial expenses
3) Mandate reporting of primary and secondary results in clinical trials by sex
a) Journal editors require sex-specific reporting in all primary manuscripts
b) Publish or web post brief secondary presentations and/or papers on results in women
c) Explore alternative ways to enhance accessibility of new and existing data for review and for incorporation into meta-analyses
4) Create incentives to enhance the performance of research in women
a) Alter pre-market investigational paradigm regarding sex-based data
b) Identify business incentives
c) Implement new FDA policies requiring discussion of the impact of sex before devices or drugs receive approval
d) Consider extensions in patent duration for enhanced pre-clinical testing of drugs and devices in women
e) Increase awareness of the problem among investigators, industry, and regulators