The role of comparative effectiveness research in transfusion medicine clinical trials: proceedings of a National Heart, Lung, and Blood Institute workshop

Transfusion ◽  
2012 ◽  
Vol 52 (6) ◽  
pp. 1363-1378 ◽  
Author(s):  
Morris A. Blajchman ◽  
Jeffrey L. Carson ◽  
John W. Eikelboom ◽  
Nancy M. Heddle ◽  
Jacques Lacroix ◽  
...  
2013 ◽  
Vol 187 (12) ◽  
pp. 1382-1387 ◽  
Author(s):  
Yvonne J. Huang ◽  
Emily S. Charlson ◽  
Ronald G. Collman ◽  
Sandra Colombini-Hatch ◽  
Fernando D. Martinez ◽  
...  

Global Heart ◽  
2018 ◽  
Vol 13 (2) ◽  
pp. 65 ◽  
Author(s):  
Michael M. Engelgau ◽  
K.M. Venkat Narayan ◽  
Majid Ezzati ◽  
Luis A. Salicrup ◽  
Deshiree Belis ◽  
...  

2020 ◽  
Vol 4 (3) ◽  
pp. 229-232
Author(s):  
Kevin Fiscella ◽  
Mechelle Sanders ◽  
Tameir Holder ◽  
Jennifer K. Carroll ◽  
Amneris Luque ◽  
...  

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.


2012 ◽  
Vol 30 (34) ◽  
pp. 4194-4201 ◽  
Author(s):  
Olwen M. Hahn ◽  
Richard L. Schilsky

Comparative effectiveness research (CER) has been promoted as a way to improve the translation gap between clinical research and everyday clinical practice as well as to deliver more cost-effective health care. CER will account for a significant portion of funding allocated by the US government for health care research. Oncology has a rich history of improving clinical outcomes and advancing research through randomized controlled trials (RCTs). In this article, we review the role of RCTs in achieving the goals of CER, with particular emphasis on the role of publicly funded clinical trials.


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