Statistics Collaborative - Design and analysis for biomedical research

Therapeutic AreasTherapeutic Areas

Psychiatry and psychology

Psychiatric and psychological disorders present unique challenges to statistical design. Issues include high rates of noncompliance by subjects and outcomes that are difficult to measure quantitatively. Statistics Collaborative, Inc. (SCI) has experience working with psychological outcomes that are primarily secondary outcomes of other treatments under investigation. These may range from neuropsychological functioning, to adverse events such as the development of depression or suicidality during the course of a study, to changes in quality of life while a subject is on the study treatment.

Our clients seek our expertise in design and the careful thought we give to statistical approaches for the analysis of these complex psychological outcomes.

Examples of SCI’s work in psychiatry and psychology:

  • Depression: SCI assisted in the design of a Phase 3 clinical trial to evaluate the incidence of suicidal ideation or depression occurring at a very low rate as a possible side effect of treatment with a non-neuropsychological drug. SCI has analyzed trials evaluating non-neuropsychological treatments, such as a treatment for hepatitis, that use as outcomes validated psychological assessment scales.
  • IQ: SCI assisted in the design of a long-term clinical trial for monitoring changes in IQ in patients with phenylketonuria (PKU), which, left untreated, would lead to the lowering of IQ.
  • Consulting for the National Institute of Mental Health (NIMH): SCI consulted on the design and analysis for clinical trials for evaluating interventions for mental health conditions.

Examples of papers:

  • Kranzler HR, Wesson DR, Billot L. Naltrexone depot for treatment of alcohol dependence: A multi-center, randomized, placebo-controlled clinical trial. Alcoholism: Clinical and Experimental Research 2004; 28:1051-1059.