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Clinical Trials Branch

The Clinical Trials Branch (CTB) of the Division of Geriatrics and Clinical Gerontology (DGCG) plans and administers larger-scale and some medium-scale clinical trials on age-related issues that require extensive specialized clinical trials expertise. Trials are ranging in size from 100 to 19,000 participants, with many studies being Phase II trials. Examples of interventions for trials include:

  • Interventions for  common geriatric conditions;
  • Interventions that may affect multiple outcomes, including trials in older persons with multiple chronic conditions or risk factors that may be differentially affected;
  • Interventions for specific conditions whose effects on other coexisting conditions or risk factors have not been adequately evaluated;
  • Interventions that may improve prevention and  treatment options for older persons with multiple chronic conditions or risk factors;
  • Trials in older persons to determine the value of treatment for conditions or risk factors for which indications for preventive or therapeutic interventions are unclear;
  • Interventions in young, middle-aged, or older persons that affect risk factors reflecting aging processes;Pragmatic patient-centered randomized controlled trials of interventions targeted at patients, families, healthcare providers, communities or healthcare systems through the integration of randomized clinical trials into existing clinical practice settings while minimizing separate research infrastructure and staff;
  • Interventions that may favorably influence multiple predictors of life span or health span, and aging mechanisms that affect these predictors.

For more information about select DGCG-funded clinical trials please  visit their websites:

Resources

In collaboration with other NIA Divisions, the clinical trials branch develops and makes available to the research community informational and education resources to ensure safety of participants and high quality of data collected in NIA-funded trials. These resources include the NIA Clinical Research Toolbox and NIA Safety Training Course. The NIA Clinical Research Toolbox is an information repository that contains templates, sample forms, guidelines, regulations and information materials to assist investigators in the development and conduct of high quality clinical research studies. The Safety Training Course provides guidance on responsibilities regarding the fundamentals of safety surveillance and reporting in clinical trials funded by the National Institute on Aging.

Courses are also available from NIH on Good Clinical Practice (GCP). Links to Good Clinical Practices Training Courses  are: