Status women cardiovascular clinical trials

Abstract Read article for free, via Unpaywall a legal, open copy of the full text. Kim ES ,. Venu Menon Search articles by 'Venu Menon'. Menon V.

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Abstract No abstract provided. Heart disease and stroke statistics update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee.

Show 10 more references 10 of Smart citations by scite. The number of the statements may be higher than the number of citations provided by EuropePMC if one paper cites another multiple times or lower if scite has not yet processed some of the citing articles.

Explore citation contexts and check if this article has been supported or disputed. The impact of repeated, local heating-induced increases in blood flow on lower limb endothelial function in young, healthy females. Similar Articles To arrive at the top five similar articles we use a word-weighted algorithm to compare words from the Title and Abstract of each citation. Women in clinical trials--a portfolio for success.

There is no women's health crisis. Does exclusion or inclusion better protect women? Although there are lifestyle, environmental, and behavioral differences, there are also biological differences at the molecular and cellular level.

They concluded that sex being male or female should be recognized as an important variable in research and increased knowledge in this area should be cultivated. Sex differences can be observed in various disease states in prevalence, diagnosis, severity, and outcomes. Diseases which disproportionally affect women indicate a disease burden that is greater in women than in men. Examples include breast cancer and urinary incontinence.

For example, women with cardiovascular disease may experience differences in signs or symptoms. In addition, there may be differences in patient outcomes or responses to treatment between men and women. It is important to determine if these differences are clinically relevant, as it may result in differences in safety or efficacy of prescription products between men and women. The differences between the sexes in circulating levels of endogenous hormones, such as testosterone and estradiol, can affect pharmacokinetic or pharmacodynamic parameters.

Other differences seen between the sexes e. Pharmacodynamic differences between the sexes have been observed for particular drugs. For example, women are at increased risk of experiencing torsades de points, a potentially fatal arrhythmia, after taking drugs which prolong the QT interval. Although detected pharmacokinetic and pharmacodynamics differences may not indicate clinically meaningful outcomes, there are still differences that may be clinically significant yet remain unknown.

Health disparities are also observed between men and women, which may be due to biological, cultural, social, or economic factors.

In addition, potential sex differences should be studied at all lifestages. It has been recommended that sex and gender be examined as separate effects, especially when considering potential differences in diagnosis and treatment options between men and women.

Women should be prospectively included and evaluated through all phases of drug development. Finally in , a discussion about women in clinical trials lead by the FDA and the Food and Drug Law Institute concluded that in order to understand the response of women to pharmaceutical agents, young women needed to be included in clinical trials. Discussed below are the history and progress in the U. This guidance document stated that women of child-bearing potential should be excluded from Phase 1 and early Phase 2 research, except if these studies were being conducted to test a drug for a life-threatening illness.

If a drug appeared to have a favorable risk-benefit assessment, women could then be included in later Phase 2 and Phase 3 trials if animal teratogenicity and fertility studies were finished.

The FDA articulated the importance of examining differences in safety, efficacy, pharmacokinetics, and when necessary, pharmacodynamics among population subsets. This regulation specifically states that New Drug Applications NDA must present safety and efficacy data for important populations, including sex, age, and racial subgroups.

The FDA has the authority to refuse to file any NDA that does not analyze the safety and efficacy data appropriately by sex. The rule also calls for sponsors to report the demographics of participants in its clinical trials in Investigational New Drug Application IND annual reports as a means to alert either party to potential deficiencies in the NDA submission. This rule applies to studies involving patients with the disease or condition the drug is intended to treat; the rule does not apply to studies enrolling only health volunteers.

The OWH has two overarching goals: 1 to protect and advance the health of women through policy, science, and outreach and 2 to advocate for the participation of women in clinical trials and for sex, gender, and subpopulation analyses.

The FDA OWH partners with other governmental agencies and national groups to reach out to both the scientific and lay communities. In response to the report by the U. Four issues were addressed: 1 that the NIH ensure that women and minorities be included in all clinical research; 2 that numbers in Phase 3 clinical trials be sufficient to allow for valid analyses of potential differences; 3 that these groups could not be excluded due to trial costs; and 4 that the NIH create programs and support outreach efforts to enroll and retain women and minorities in clinical trials.

The NIH does not fund any grant or project that is out of compliance on one of these four issues. Additionally, the ORWH establishes programs to increase the number of women who pursue careers in biomedical research. When attempting to assess the actual number of women enrolled in clinical trials, various investigators have reached different conclusions. The numbers and percentages can vary depending on the kinds of trials included in the analyses. The FDA conducted two surveys in the s to assess women as participants in clinical studies.

The first, published in , looked at 11 pending NDAs. The FDA determined that the proportion of men and women in later phase clinical studies was appropriate once adjusted for age-related differences in disease expression for the proposed indications.

In , FDA examined 20 NDAs and found that two did not have the right proportion of men and women in later phase clinical trials. In , the U. It is important to note that many of the drug studies were conducted and submitted to the FDA before the requirement.

The authors concluded that women and men participated in clinical trials at levels consistent with the prevalence of the disease state studied. In addition, the clinical trials section of randomly-selected IND annual reports were studied. The GAO did find that women constituted the majority of drug trial participants; the percentage of women varied with the stage of clinical research performed. Every NDA reviewed had enough women in the pivotal studies for a statistical determination that the drug was effective in this population.

Three additional studies have been more recently published in and Menon V. Affiliations All authors 1. Share this article Share with email Share with twitter Share with linkedin Share with facebook. Abstract No abstract provided. Heart disease and stroke statistics update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee.

Show 10 more references 10 of Smart citations by scite. The number of the statements may be higher than the number of citations provided by EuropePMC if one paper cites another multiple times or lower if scite has not yet processed some of the citing articles. Explore citation contexts and check if this article has been supported or disputed. The impact of repeated, local heating-induced increases in blood flow on lower limb endothelial function in young, healthy females.

Similar Articles To arrive at the top five similar articles we use a word-weighted algorithm to compare words from the Title and Abstract of each citation. Women in clinical trials--a portfolio for success. There is no women's health crisis. Does exclusion or inclusion better protect women? Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute.

State of the heart: building science to improve women's cardiovascular health. Joining Europe PMC. Corresponding author. Accepted Oct 5. This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source.

This article has been cited by other articles in PMC. Abstract Purpose of review Racial, ethnic, and gender disparities in cardiovascular care are well-documented.

Introduction Cardiovascular disease CVD is recognized as the leading cause of death among both genders [ 1 ], but there are unique pathophysiological and clinical features of CVD in women [ 2 , 3 ].

Traditional CV risk factors Hypertension is one of the traditional risk factors that affects women more severely than men. Non-traditional CV risk factors Psychological stress among minority populations [ 53 ] is associated with worse CV health, even after correcting for differences in socioeconomic status [ 54 ].

Female-specific CV risk factors Common female-specific CV risk factors are early menarche and menopause, young maternal age, polycystic ovarian syndrome PCOS , preeclampsia, gestational diabetes, preterm delivery, recurrent miscarriages, and obesity prior to pregnancy Fig.

Open in a separate window. Cardiac care for women beyond Despite recent efforts by federal agencies including the FDA [ ] and NIH [ ] to increase the representation of women and minority groups in CV clinical trials, these groups remain underrepresented and underreported [ 29 , ]. Human and Animal Rights and Informed Consent This article does not contain any studies with human or animal subjects performed by any of the authors. References and Recommended Reading 1.

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