MARINA DEL REY, Calif.--(ISCTM) gathered this month for its autumn meeting in Marina del Rey, CA.)--In its on-going work to overcome clinical research obstacles in the development of novel CNS therapeutics, the International Society for CNS Clinical Trials and Methodology (
“Absent a strong rationale to do otherwise, it may be more relevant to not require current biomarkers for trials entry in this setting and to restrict their use as explanatory or stratification variables when there are reasons to do so”
In Alzheimer’s disease, hypotheses have met the reality of clinical application, causing multiple research programs to fail or change course. These recent setbacks have showcased the scientific struggles involved in targeting the right patients for the right interventions at the right time in the course of their disease. Targeted clinical trials using the principles of stratified medicine – matching patients based on their genetic makeup and other characteristics to specific therapies – may help to point a way forward in the development of new Alzheimer’s medicines
“Absent a strong rationale to do otherwise, it may be more relevant to not require current biomarkers for trials entry in this setting and to restrict their use as explanatory or stratification variables when there are reasons to do so,” according to session co-chair Lon S. Schneider, MD, Professor of Psychiatry, Neurology, and Gerontology, USC, Keck School of Medicine.
ISCTM will continue working to advance the science, and encourage new exploration of biomarkers that can inform the development of new treatments.
Addressing a similar set of scientific challenges, researchers are working at the opposite end of the age spectrum to develop new therapies for patients with autism spectrum disorders.
“The increased recognition of autism and autism spectrum disorders poses an extraordinary challenge for treatment development, including drug development. We’re at an important juncture,” stated Lawrence Scahill, MSN, PhD, Professor, Director of Pediatric Psychopharmacology Research Unit, Yale School of Medicine.
“Our autumn conference reflects our mission to focus on areas where innovation in research methods can help bridge the chasm between scientific discovery and clinical practice,” noted Dr. Richard Keefe, Professor of Psychiatry, Duke University Medical Center and President of ISCTM. The success of ISCTM can be attributed to the active involvement of leaders across the FDA, NIMH, academia, and the pharmaceutical industry who have used ISCTM as a collaborative forum to address common barriers to the development of new CNS therapies.
The 9th Annual ISCTM meeting takes place 19-21 February 2013, Washington, DC.