explanatory trial
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2019 ◽  
Vol 19 (6) ◽  
pp. 575-576 ◽  
Author(s):  
Ibrahim Abubakar ◽  
Sarah Meredith ◽  
Andrew J Nunn ◽  
Patrick P J Phillips ◽  
I D Rusen

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18188-e18188
Author(s):  
Nupur Mittal ◽  
Anil George ◽  
Lizette Leanos ◽  
Paul Kent

e18188 Background: In 2016, President Obama announced the “Moonshot Cancer Initiative” to advance cancer research. One of the key components of this initiative is promoting enrollment in pragmatic clinical trials and data sharing. As described in 2009 by Thorpe et al, using the 9-domian PRECIS-2 tool, a ‘pragmatic’ trial, as opposed to an ‘explanatory’ trial used to confirm a physiologic hypothesis, is one in which the intervention can be immediately applied into real-world clinical practice (J of Clin Epi:2009). In the US, 60%-90% children are enrolled on COG research trials. State-of-the-art treatment for a child is derived from superior therapy identified in prior trials which then serves as the standard arm of subsequent phase-III trials and becomes the de facto practice guideline and ‘standard of care’ .To accomplish this goal, COG shares its data among the 242 member institutions.Our objective is to assess “pragmatism” in COG trials. Methods: We analyzed the 158 COG phase III clinical trials between 2006-2016 for all 9 domains of the PRECIS-2 (Table 1) and graded them from 1-5 (most explanatory to most pragmatic). Results: Out of 152 phase III clinical trials on the COG website, 138 (91%) scored 5/5 for all 9 PRECIS pragmatic domains and 148 (98%) scored >4. The scoring for all 9 domains is in table 1. Conclusions: COG provides nearly all children in the United States access to pragmatic phase III research as outlined in the Moonshot Goals. Goal of merging evidence-based standard care accessible to all and conducting well- designed clinical research to identify the best therapies has been accomplished by COG and should serve as an example to other cancer organizations. 9 domains of PRECIS-2 to assess pragmatism in clinical trials. [Table: see text]


2013 ◽  
Vol 14 (5) ◽  
pp. 2835-2838 ◽  
Author(s):  
Narayan Prasad Belbase ◽  
Chandra Shekhar Agrawal ◽  
Paras Kumar Pokharel ◽  
Sudha Agrawal ◽  
Madhab Lamsal ◽  
...  

1994 ◽  
Vol 30 (9) ◽  
pp. 1244-1250 ◽  
Author(s):  
P.L.I Dellemijn ◽  
H.B.C Verbiest ◽  
J.J van Vliet ◽  
P.J Roos ◽  
C.J Vecht

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