One response by the NIMH, described by Javier Escobar, MD, of the University of Medicine and Dentistry of New Jersey, is the development of a program with 15 to 20 senior researchers to serve as mentors for young investigators. Another NIMH initiative is formation of a National Psychiatry Training Council to assess the shortage and recommend corrective measures. The council, consisting of about 75 representatives of varied stakeholders, issued a report in 2006 that indicates that the shortage of physician investigators is acute in clinical and translational research, particularly in the subspecialties of child and adolescent, addiction, and geriatric psychiatry.Minority involvement in research
A program to increase the number of minority postdoctoral investigators was described by Warachal Faison, MD, and Jacobo Mintzer, MD, of the Medical University of South Carolina (MUSC). Their group used a grant from the National Institute on Aging to develop the Institute for Research Minority Training on Mental Health and Aging. The program was characterized as a "unique approach that combines the benefits of a national cadre of mentors with a locally produced and nationally delivered research didactic training."
In discussions on recruiting research subjects, there were similar concerns with the low representation of minority populations. "Historically, people of African descent in the United States have been largely excluded from clinical trials, possibly contributing to health and health care disparities," Basil Halliday, MSc, of Meharry Medical College, observed.
Halliday identified several factors contributing to this underrepresentation, including the cost of delaying clinical trials to undertake more difficult recruiting programs, acceptance of status quo, and the practice of obtaining data from diverse populations outside the United States. Halliday advocated, however, for systematic planning to improve recruitment of African Americans. These plans, he indicated, "should acknowledge the history of mistrust borne by this group, and attempt to establish clear guidelines that address this history."
Mintzer described an approach at MUSC to increase recruitment of African American subjects for a clinical trial in Alzheimer disease (AD). This recruitment effort emphasized education about the early symptoms of AD and potential therapies and involved local primary care physicians and family members.
Danielle Laborde, PhD, MPH, of HERMES LLC, a health research and educational services company in Durham, NC, pointed to a lack of formal training programs to prepare mental health researchers to engage diverse populations in research programs. In response, her company has developed a training module to facilitate collaborative efforts of investigators with African American community leaders. "The training materials, which include experiential exercises and case studies, have been well received by research psychiatrists and other mental health researchers in cooperative learning and workshop formats," Laborde indicated.Research on children
The challenges in recruiting suitable populations of children for clinical trials were addressed; it was noted that there are particular difficulties in recruiting children for studies of schizophrenia. "Juvenile-onset schizophrenia has unique treatment challenges and requirements, particularly in confirming the diagnosis for adolescents exhibiting symptoms and the interacting combination of biopsychosocial factors that occur in this population," observed Margaretta Nyilas, MD, of Otsuka Pharmaceutical.
Linmarie Sikich, MD, of the University of North Carolina, Chapel Hill, related her experience with recruiting child subjects for 2 studies, one of early-onset schizophrenia and the other of pharmacological interventions for autism. Sikich noted that the enrollment eligibility criteria for the first study had been changed twice—once because of safety concerns, and the other in response to challenges associated with recruiting subjects receiving only an antipsychotic medication. Sikich indicated that there had been a particularly high standard set by the Investigational Review Board before approving the study, including the requirement for both informed consent and assent.
The lack of data on drug dose response in children, and the relatively few approved indications for psychiatric drugs provide impetus for conducting studies with this age group, however, and several examples of successful large-scale studies with children were described at the meeting. John T. Walkup, MD, of Johns Hopkins University, noted 3 clinical drug trials that also provide a comparison of medication to psychotherapy: the Multimodal Treatment Study of ADHD, the Treatment for Adolescents with Depression Study, the Pediatric Treatment Study, and the Child/Adolescent Anxiety Multimodal Study.
Walkup noted that the lack of sham psychotherapeutic arms and combination treatment with placebo in these studies may limit inferences about the interaction of treatment conditions, but found this arguable flaw in design to be "offset by enhancement in feasibility and generalizability of study results to clinical practice."
Involvement with research design and methodology at this year's NCDEU appeared to go beyond academic interest to embrace the responsibilities in moving compounds from bench to bedside. In introducing a workshop on assessment design, detection of onset and suicide risk, Mark Rapaport, MD, Cedars-Sinai Medical Center, Los Angeles, cautioned, "In this time of continued public scrutiny, stringent regulatory and congressional oversight, it is imperative to carefully assess and rigorously re-evaluate how we conceptualize treatment outcomes that are employed to determine the success of our experimental interventions."