Editorial

928 www.thelancet.com Vol 383 March 15, 2014

For the NIMH Directors
announcement see http://www.
nimh.nih.gov/about/
director/2014/a-new-approach-
to-clinical-trials.shtml
For the NIMH portfolio analysis
see http://www.nimh.nih.gov/
funding/opportunities-
announcements/
clinical-trials-foas/changing-
nimh-clinical-trials-e ciency-
transparency-and-reporting.shtml
For The Lancet Series on
Research: increasing value,
reducing waste see http://
image.thelancet.com/series/
research
The US National Institute for Mental Health (NIMH) has
revised its policy for funding clinical trials. No longer will it
be su cient to establish whether or not an intervention is
eective. All trials, pharmacological and psychosocial, now
need to identify a target or mediator, and to show how it
is aected by the intervention. This change is a welcome
progression from the Institutes 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 beneted is unclear. The lack of novel targets has
led many drug companies to withdraw from psychiatric
pharmacology altogether. Psychosocial inter ventions
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
e ciency 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, eective
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 NIMHs announcement,
and look forward to reading and publishing the resulting
research. The Lancet
Hitting the target: a new framework for mental health trials
Promoting equity through sex-specic medical research
On March 3, the Mary Horrigan Connors Center for
Womens Health and Gender Biology at Brigham and
Womens Hospital released Sex-Specic Medical Research:
Why Womens Health Cant Wait at a womens 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 dierent risks for the onset, course, and treatment
response of many diseases, it is important to integrate
sex-specic analysis in all aspects of researchfrom 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
dierences 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-specic health
research on new drugs and devices; and adopt clinical
practices and training curricula that incorporate gender
equity in health research.
Despite advances in womens 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 Alzheimers disease will aect women
disproportionately. Greater attention to sex dierences
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-specic analysesideals that should be embraced
internationally. The Lancet
For Sex-Specic Medical
Research: Why Womens Health
Cant Wait see http://www.
brighamandwomens.org/
Departments_and_Services/
womenshealth/ConnorsCenter/
Policy/ConnorsReportFINAL.pdf

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