Investigator initiated multi-center clinical trials and the national institutes of health

1980 ◽  
Vol 1 (2) ◽  
pp. 179-180
Author(s):  
Charles G. Hollingsworth ◽  
Fred P. Heydrick
Keyword(s):  
Clinical Trials ◽  
National Institutes Of Health

scholarly journals A Modified National Institutes of Health Stroke Scale for Use in Stroke Clinical Trials

Stroke ◽  
2001 ◽  
Vol 32 (6) ◽  
pp. 1310-1317 ◽  
Author(s):  
Patrick D. Lyden ◽  
Mei Lu ◽  
Steven R. Levine ◽  
Thomas G. Brott ◽  
Joseph Broderick
Keyword(s):  
Clinical Trials ◽  
National Institutes Of Health

scholarly journals The role of data and safety monitoring boards in implementation trials: When are they justified?

2020 ◽  
Vol 4 (3) ◽  
pp. 229-232
Author(s):  
Kevin Fiscella ◽  
Mechelle Sanders ◽  
Tameir Holder ◽  
Jennifer K. Carroll ◽  
Amneris Luque ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Safety Monitoring ◽  
National Institutes Of Health ◽  
Phase Iii ◽  
Blood Institute ◽  
Phase Iii Clinical Trials ◽  
National Heart Lung ◽  
Cooperative Agreements ◽  
Monitor Data

AbstractThe National Institutes of Health requires data and safety monitoring boards (DSMBs) for all phase III clinical trials. The National Heart, Lung and Blood Institute requires DSMBs for all clinical trials involving more than one site and those involving cooperative agreements and contracts. These policies have resulted in the establishment of DSMBs for many implementation trials, with little consideration regarding the appropriateness of DSMBs and/or key adaptations needed by DSMBs to monitor data quality and participant safety. In this perspective, we review the unique features of implementation trials and reflect on key questions regarding the justification for DSMBs and their potential role and monitoring targets within implementation trials.

scholarly journals Translational impact of NIH-funded nonhuman primate research in transplantation

2019 ◽  
Vol 11 (500) ◽  
pp. eaau0143 ◽  
Author(s):  
Stuart J. Knechtle ◽  
Julia M. Shaw ◽  
Bernhard J. Hering ◽  
Kristy Kraemer ◽  
Joren C. Madsen
Keyword(s):  
Clinical Trials ◽  
Cell Therapy ◽  
Immune Responses ◽  
Nonhuman Primate ◽  
Immune Cell ◽  
National Institutes Of Health ◽  
Primate Research ◽  
Costimulation Blockade ◽  
Hematopoietic Chimerism ◽  
New Treatments

The National Institutes of Health (NIH) has long supported using nonhuman primate (NHP) models for research on kidney, pancreatic islet, heart, and lung transplantation. The primary purpose of this research has been to develop new treatments for down-modulating or preventing deleterious immune responses after transplantation in human patients. Here, we discuss NIH-funded NHP studies of immune cell depletion, costimulation blockade, regulatory cell therapy, desensitization, and mixed hematopoietic chimerism that either preceded clinical trials or prevented the human application of therapies that were toxic or ineffective.

Sign in / Sign up

Export Citation Format

Share Document