Objectives of the Society
The International Society for CNS Clinical Trials and Methodology (ISCTM) is a independent multi-disciplinary organization devoted to promoting advances in, and dissemination of, clinical research methods related to development and use of CNS therapeutics. The ISCTM accomplishes this by bringing together international stakeholders representing academia, industry, government, payers, policymakers, and the public to address strategic clinical, regulatory, methodological and policy challenges in clinical research.
This society specifically deals with the strategic aspects of clinical trial design, other methodological issues and regulatory issues that confound CNS drug development.
In particular, existing forums do not adequately address gaps/disconnects among objectives/indications, regulatory demands/requirements and clinical feasibility in the CNS area.
In contrast, the fields of oncology, immunology, and cardiology have developed extensive interactions among academics, regulators, and industry scientists, and this process has significantly improved clinical research in these disciplines.
This society should serve as a forum to fundamentally re-evaluate current concepts of CNS drug development, including new therapies and indications, methodologies for evaluating these therapeutic approaches, the associated regulatory guidelines, the modes of usage of these drugs, and the clinical methodology associated with the use of these drugs both in the research and practice settings.
This society will be rigorously scientific in character and will not be dominated by any special interest group or company. Conscious efforts shall be made to avoid the perception that the society represents an opportunity for marketing of commercial products or for off-label use of existing products.
The independence of the society will be maintained by a close integration of representatives from academia, industry, regulators and others with strong interest in methodology and teaching.