Director’s Blog: August at NIMH
August tends to be a sleepy time inside the Beltway. Congress is in recess, families are at the beach, and traffic is mercifully light. But at NIMH, where we are working to finalize grants and contracts before our fiscal year ends in September, this is one of the busiest times of the year. And this year, with over 60 new awards for the BRAIN Initiative and several large efforts, like our new consortium for autism biomarkers, the end of the summer is even busier than usual.
In addition to the new science we are supporting, I want you to know about a new report about our clinical trials portfolio. In a previous report, I pledged our commitment to doing better trials with a focus on efficiency (rapid recruitment, retention, and completion), transparency (registration in ClinicalTrials.gov ), and reporting (publication and sharing of the results). In 2014, NIMH changed its approach to supporting clinical trials by requiring new standards for testing treatment mechanisms as well as efficacy, converting many trials to contracts with milestones, and expecting data sharing in the course of running the trial. More recently, we have required multi-site trials to use a centralized institutional review board (IRB). And we have hired project managers to ensure that investigators meet their milestones.
Last week we posted a progress report. Some of the news is good. Nearly all trials are now registered in ClinicalTrials.gov and the publication rate improved to 87 percent publishing results within three years, with an average of six months between completion and publication. But there is still room for improvement. It takes too long to launch a trial, recruitment remains a challenge for many studies, and our National Database for Clinical Trials Related to Mental Illness (NDCT ) is still mostly populated with data from our legacy trials. Perhaps what is most surprising in this progress report is the drop in the number of clinical trials. Looking at the numbers using the new NIH definition of “clinical trial,” the number of studies has increased; however, by our traditional definition, the number of trials has, in fact, dropped over 40 percent over the past five years (from 224 trials in 2009 to 131 trials in 2014).
Why the drop? While this drop mirrors a similar reduction in the pharmaceutical industry, where central nervous system projects fell from 267 to 129 trials over the same period, NIMH’s investments in clinical trials have traditionally been, and continue to be, more in psychosocial than pharmacological studies, so, we are not simply following the private sector.1 The drop does not reflect lack of interest in the development of either psychosocial or biomedical treatments—NIMH continues to be passionate about the need for new and better treatments. For NIMH, the reduction in the number of trials reflects three concerns. First, since our budget has stalled, we have reduced investments in many areas, especially in some of the more expensive projects like large clinical trials. Second, the impact of many of our recent trials was not evident, either in changing clinical practice or in reducing morbidity and mortality. And finally, over the past five years, the Institute has begun to consider new approaches to clinical trials. New approaches include the intensive experimental medicine focus with an identified target as well as extensive large scale trials that leverage changes in technology and health care.
Some of our current trials exemplify this extensive, large scale approach. One project, led by Dr. Patricia Arean (now at the University of Washington), recruited 1500 people with depression in four months and completed an online intervention trial in eight months. Another set of projects, based on a “practice to research” model led by Dr. Greg Simon at Group Health, has used the Mental Health Research Network of 10 million patients, supported by common electronic medical records within a data warehouse, to quickly assess interventions for suicide prevention. These trials may not get at mechanisms at the molecular level, but they can begin to help us understand what works for whom in real-world settings.
Going forward, NIMH wants to support both intensive trials that look at mechanisms, and extensive trials that answer urgent questions in practice settings. We need better treatments and we need better information about how to use current treatments. Over the past five years, we have seen new medications for rapid response in treatment-resistant depression, new devices for neuromodulation, and new psychosocial interventions. Now we have an opportunity to test how to improve, how to combine, and how to disseminate these innovations. And that is one reason why we are working overtime to get new grants and contracts awarded during one of our busiest times of the year here at NIMH.
1 Pankevich DE et al. Improving and accelerating drug development for nervous system disorders. Neuron. 2014 Nov 5;84(3):546-53. doi: 10.1016/j.neuron.2014.10.007. Epub 2014 Nov 5.