Research-to-Policy Forum: Are Clinical Trials of New Treatments for Chronic CNS Diseases Early Enough and Long Enough?

Chairs: Reuven Ferziger MD,  Larry Ereshefsky PharmD, BCPP, Ron Manderscheid, PhD

Drug development activities typically support relatively short-term clinical trials, often focused on improvement or resolution of more acute symptomatology.  Few clinical trials are designed to measure longer term outcomes associated with maintenance of improvement, earlier intervention or modification of disease progression.  However, for certain CNS conditions, such as schizophrenia or Alzheimer’s disease, the most effective therapies may need to be initiated early in the course of disease or even prior to symptomatic onset.  The evaluation of such long term interventions will present challenges to a research and pharmaceutical culture constrained by shorter term operating budgets and influenced by 5 year NIH grants, 4 year elected officials and myopic shareholder expectations.  The 2012 ISCTM Policy Forum will address the scientific and policy challenges of evaluating new treatments for CNS conditions that require intervention much earlier in the course of disease than most current therapies.