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Clinical Trials

Hinda and Arthur Marcus Institute for Aging Research hosts and collaborates on clinical trials through its Interventional Studies in Aging Center (ISAC).

Mission: To develop and support clinical trials and intervention studies preserving and improving the health and quality of life of older individuals.

Rationale: The translation of discoveries in basic and clinical science to improvements in public health requires formal proof of the safety, efficacy, and effectiveness of novel therapies in clinical trials. These studies are immensely challenging, requiring distinct methodology and adherence to rigorous standards set forth by regulators, top-tier journals, and the broader community of science. These in turn necessitate unique investigator expertise and state-of-the art infrastructure to support experimental design, data and project management, adherence to human subjects regulations, efficient planning and execution, valid statistical analysis, and proper dissemination of findings.

The HSL Marcus Institute is uniquely poised to lead the design and conduct of clinical trials in older populations. The expertise at the Marcus Institute is well-suited to trials of cognitive, behavioral, functional, nutritional, technological, and multicomponent interventions in vulnerable older persons in various healthcare settings. Properly conducted, these trials will directly inform clinical and policy decisions pertaining to the health of older persons.

ISAC supports interventional studies that are being proposed and conducted primarily by Marcus Institute faculty. ISAC supports traditional clinical trial designs, but has particular expertise conducting trials testing non-pharmacological, multicomponent interventions and that use cluster randomization. ISAC is also focused on conducting placed pragmatic trials embedded into the heath care systems or settings that care for older persons.

ISAC’s aim is to streamline research processes so trials are completed and reported as rigorously and efficiently as possible, and in full compliance with ethical and regulatory standards.  ISAC’s work will emphasize collaboration with both internal and external research teams and training of young investigators as well as project staff in conducting clinical trials.

Activities include:

  • Consultation for design and conduct of clinical trials 
  • Collaborative grant review and preparation for proposals involving clinical trials
  • Biostatistical design and analytic support for ongoing Marcus Institute projects and applications in development
  • Technical assistance including development of protocols and manuals of operation, compliance reports, database collection tools, and data management for active trials of non-pharmacological intervention trials in older persons.
  • Provide junior investigators and project staff with rigorous training in interventional research design and data analysis of clinical and quantitative scientists, with emphasis on the epidemiology and treatment of illnesses of aging.