Editorial

©2014, Brigham and Women’s Hospital

Promoting equity through sex-specific medical research

For Sex-Specific Medical Research: Why Women’s Health Can’t Wait see http://www. brighamandwomens.org/ Departments_and_Services/ womenshealth/ConnorsCenter/ Policy/ConnorsReportFINAL.pdf

On March 3, the Mary Horrigan Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital released Sex-Specific Medical Research: Why Women’s Health Can’t Wait at a women’s health summit in Boston, MA, USA. The report aims to assess progress on inclusion of women in clinical research as mandated in the National Institutes of Health (NIH) Revitalization Act of 1993, which sought to make greater representation of women and minorities in health research a US national priority. Recognising that women and men have different risks for the onset, course, and treatment response of many diseases, it is important to integrate sex-specific analysis in all aspects of research—from basic science to clinical trials, and in subsequent translation into practice and evaluation of clinical outcomes. The report acknowledges that notable advances have been made in maternal health, but notes that sex differences are frequently excluded or inadequately addressed, especially in early stage research. Although women are now routinely included in clinical trials, equity

is far from being achieved. To address research disparities, the report recommends that US Federal Agencies, including the NIH, should require design, analysis, and reporting of health research by sex; promote transparency and disclosure regarding the absence of sex-specific health research on new drugs and devices; and adopt clinical practices and training curricula that incorporate gender equity in health research. Despite advances in women’s health, such as reductions in the burdens of cervical cancer and heart disease in women, there is still much to do; for example, the growing burden of Alzheimer’s disease will affect women disproportionately. Greater attention to sex differences in clinical research will be needed to achieve equitable health outcomes and to improve quality of care. The report calls for renewed attention to the ideals of the NIH Revitalization Act to ensure that health research at all levels is planned and undertaken with appropriate sex-specific analyses—ideals that should be embraced internationally. „ The Lancet

Simon Fraser/Dept of Neuroradiology, Newcastle General Hospital/Science Photo Library

Hitting the target: a new framework for mental health trials

For the NIMH Director’s announcement see http://www. nimh.nih.gov/about/ director/2014/a-new-approachto-clinical-trials.shtml For the NIMH portfolio analysis see http://www.nimh.nih.gov/ funding/opportunitiesannouncements/ clinical-trials-foas/changingnimh-clinical-trials-efficiencytransparency-and-reporting.shtml For The Lancet Series on Research: increasing value, reducing waste see http:// image.thelancet.com/series/ research

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The US National Institute for Mental Health (NIMH) has revised its policy for funding clinical trials. No longer will it be sufficient to establish whether or not an intervention is effective. All trials, pharmacological and psychosocial, now need to identify a target or mediator, and to show how it is affected by the intervention. This change is a welcome progression from the Institute’s Research Domain Criteria programme to establish, for research purposes, new ways of classifying mental disorders based on dimensions of observable behaviour and neurobiological measures. Our understanding of the human brain has advanced remarkably, with neuroimaging, genomic techniques, and molecular biology combining to give detailed pictures of normal development and pathogenesis. Unfortunately, how much patients with mental disorders have benefited is unclear. The lack of novel targets has led many drug companies to withdraw from psychiatric pharmacology altogether. Psychosocial interventions and neuromodulatory technologies, such as deep brain stimulation, have seen a greater degree of innovation but the underlying mechanisms remain poorly understood.

Announcing the new NIMH policy, Director Thomas Insel stated as his goal that “interventions serve not only as potential treatments, but as probes to generate information about the mechanisms underlying a disorder”, for example by modulating a neural pathway. From an analysis of their current portfolio, NIMH concluded that many clinical trials are not correctly registered in public databases and take too long to report results. In line with the movement demanding greater efficiency and accountability in research, as discussed in a recent Lancet Series, NIMH is introducing stricter requirements for patient recruitment, trial registration, publication, and data sharing. People with mental health problems need and deserve innovative, effective treatments. The NIMH approach should facilitate the development of new therapies and greater knowledge of the biological, psychological, and social underpinnings of mental illness. The Lancet and its new sister journal The Lancet Psychiatry welcome NIMH’s announcement, and look forward to reading and publishing the resulting research. „ The Lancet www.thelancet.com Vol 383 March 15, 2014

Hitting the target: a new framework for mental health trials.

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