European Medicines Agency policies for clinical trials leave women unprotected

Ruiz-Cantero, María Teresa; Pardo, María Ángeles

doi:10.1136/jech.2006.048769

Cited by 20 publications

(14 citation statements)

References 10 publications

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“…Although European authorities have not yet released guidance on sex-specific trial representation, we found a higher proportion of women in international trials than in US-only trials. 13 These observations suggest that female representation in clinical trials does not necessarily correlate with the existence of specific legislation or policy on women's representation.…”

Section: Overall Representation Of Women In Randomized Clinical Studiesmentioning

confidence: 98%

Representation of Women in Randomized Clinical Trials of Cardiovascular Disease Prevention

Melloni

Berger

Wang

et al. 2010

Circ: Cardiovascular Quality and Outcomes

391

251

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Background-The (40%), and stroke (38%) and lowest for heart failure (29%), coronary artery disease (25%), and hyperlipidemia (28%). By contrast, women accounted for 53% of all individuals with hypertension, 50% with diabetes, 51% with heart failure, 49% with hyperlipidemia, and 46% with coronary artery disease. Sex-specific results were discussed in only 31% of primary trial publications. Conclusions-Enrollment of women in randomized clinical trials has increased over time but remains low relative to their overall representation in disease populations. Efforts are needed to reach a level of representation that is adequate to ensure evidence-based sex-specific recommendations. (Circ Cardiovasc Qual Outcomes. 2010;3:135-142.)

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Section: Overall Representation Of Women In Randomized Clinical Studiesmentioning

confidence: 98%

Representation of Women in Randomized Clinical Trials of Cardiovascular Disease Prevention

Melloni

Berger

Wang

et al. 2010

Circ: Cardiovascular Quality and Outcomes

391

251

View full text Add to dashboard Cite

show abstract

“…In 2005 and 2009, the European Medicines Agency (EMA) published ‘Gender considerations in the conduct of clinical trials’ ( 16 ), which stated that the publication of a specific guideline was not necessary. This statement was based on a review of the agency’s own data (about which little information is available) and using debatable arguments ( 17 ).…”

Section: Gender Bias In Knowledge Productionmentioning

confidence: 99%

Gender bias in clinical research, pharmaceutical marketing, and the prescription of drugs

Chilet-Rosell

2014

Global Health Action

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This thesis is part of the studies of gender bias in health which together with the paradigm of evidence-based medicine shares the empirical assumption that there are inaccuracies in medical practice, in addition to a lack of rigour and transparency. It worked with the distinction between the concepts of sex and gender and between the concepts of sex-related differences and gender inequalities, in terms of applying a gender perspective in the study design and the subsequent analysis. This PhD review presents the research process conducted in Spain, which can provide an example for future research. Study I described a review of 58 clinical trials (CTs) of etoricoxib to assess its compliance with the Recommendations of Evaluation of Gender Differences in the Clinical Evaluation of Drugs. In Study II, key informants from professions related to different areas in drug development and pharmacovigilance held a working meeting to reach a consensus document on recommendations for the study and evaluation of gender differences in CTs in Spain. In Study III, the websites of the eight best-selling hormone replacement therapy drugs in Spain on Google first page of results were analysed. In Study IV, a logistic regression analysis was performed to compare analgesic prescription by sex in regions with a higher or lower Gender Development Index (GDI) than the Spanish average. Gender biases identified in this thesis limited the legitimacy of medicine, which is not based on the best possible evidence. The results also demonstrate the existence of inequalities between men and women that are not due merely to biological differences, but are gender inequalities stemming from the social differences that exist between both sexes.

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“…In 2001, a report was brought about by the Institute of Medicine, which induced debate on the importance of sex in health research [27]. Regulatory guidelines have been changed to enhance inclusion of women in clinical trials [28,29].…”

Section: Introductionmentioning

confidence: 99%

Sex differences in cardiovascular drug‐induced adverse reactions causing hospital admissions

Rodenburg

Stricker

Visser

2012

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Cardiovascular disease, disease outcome, drug treatment and drug response differ between men and women. WHAT THIS STUDY ADDS• Adverse drug reactions attributed to cardiovascular drugs that require hospital admission show differences between men and women, even after taking into account age and the total number of drug prescriptions. AIMSCardiovascular disease in women is often underestimated. The effects of cardiovascular drugs differ between the sexes because of pharmacokinetic and pharmacodynamic differences. Adverse drug reactions (ADRs) within these drug classes may have serious consequences, leading to hospital admission. We aimed to study differences between men and women in hospital admissions for ADRs due to cardiovascular drugs. METHODSWe conducted a nationwide study of all hospital admissions between 2000 and 2005 with data from the Dutch National Medical Register. Relative risks were calculated of hospital admissions due to ADRs to the different cardiovascular drug groups for women compared with men. By an ecological design, risks were adjusted for the total number of Dutch inhabitants and the total number of prescriptions. RESULTSIn total, 14 207 of the hospital admissions (34% of all ADR-related admissions) were attributed to cardiovascular drugs [7690 in women (54%; 95% confidence interval 53-55%)].'Anticoagulants and salicylates' (n = 8988), 'high-and low-ceiling diuretics' (n = 2242) and 'cardiotonic glycosides' (n = 932) were responsible for the majority of the ADR-related hospital admissions. The most pronounced sex differences were seen in users of low-ceiling diuretics (relative risk 4.02; 95% confidence interval 3.12-5.19), cardiotonic glycosides (relative risk 2.38; 95% confidence interval 2.06-2.74), high-ceiling diuretics (relative risk 2.10; 95% confidence interval 1.91-2.32) and coronary vasodilators (relative risk 0.77; 95% confidence interval 0.65-0.91). CONCLUSIONSClear sex differences exist in ADRs requiring hospital admission for different cardiovascular drug groups. Sex differences should be taken into account in the prescription and evaluation of drugs.

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European Medicines Agency policies for clinical trials leave women unprotected

Cited by 20 publications

References 10 publications

Representation of Women in Randomized Clinical Trials of Cardiovascular Disease Prevention

Representation of Women in Randomized Clinical Trials of Cardiovascular Disease Prevention

Gender bias in clinical research, pharmaceutical marketing, and the prescription of drugs

Sex differences in cardiovascular drug‐induced adverse reactions causing hospital admissions

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