Design analysis indicates Potential overestimation of treatment effects in randomized controlled trials supporting Food and Drug Administration cancer drug approvals

2018 ◽  
Vol 103 ◽  
pp. 1-9 ◽  
Author(s):  
Emily M. Lord ◽  
Isabelle R. Weir ◽  
Ludovic Trinquart
Keyword(s):  
Randomized Controlled Trials ◽  
Drug Administration ◽  
Treatment Effects ◽  
Food And Drug Administration ◽  
Design Analysis ◽  
Cancer Drug ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Drug Approvals

scholarly journals Time to onset of cannabidiol treatment effects in Dravet syndrome: Analysis from two randomized controlled trials

Epilepsia ◽  
2021 ◽  
Author(s):  
Jennifer Madan Cohen ◽  
Daniel Checketts ◽  
Eduardo Dunayevich ◽  
Boudewijn Gunning ◽  
Ann Hyslop ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Treatment Effects ◽  
Dravet Syndrome ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Time To Onset ◽  
Syndrome Analysis

scholarly journals Are Randomized Controlled Trials Controlled? Patient Preferences and Unblind Trials

1997 ◽  
Vol 90 (12) ◽  
pp. 652-656 ◽  
Author(s):  
Klim Mcpherson ◽  
Annie R Britton ◽  
John E Wennberg
Keyword(s):  
Randomized Controlled Trials ◽  
Patient Preferences ◽  
Treatment Effects ◽  
Evidence Base ◽  
Modern Medicine ◽  
Treatment Preferences ◽  
Controlled Trials ◽  
True Nature ◽  
Randomized Controlled ◽  
Catch 22

The most reliable information about treatment effects comes from randomized controlled trials (RCTs). However, the possibility of subtle interactions—for example, between treatment preferences and treatment effects—is generally subordinated in the quest for evidence about main treatment effects. If patient preferences can influence the effectiveness of treatments through poorly understood (psychological) pathways, then RCTs, particularly when unblinded, may wrongly attribute effects solely to a treatment's physiological/pharmacological properties. To interpret the RCT evidence base it is important to know whether any preference effects exist and, if so, by how much they affect outcome. Reliable measurement of these effects is difficult and will require new approaches to the conduct of trials. In view of the fanciful image with which such effects are portrayed and the uncertainties about their true nature and biological mechanisms, existing evidence is unlikely to provide sufficient justification for investment in trials. This is a Catch 22. Until an escape is found we might never know, even approximately, how much of modern medicine is attributable to psychological processes.

scholarly journals Rigorous control conditions diminish treatment effects in weight loss-randomized controlled trials

2015 ◽  
Vol 40 (6) ◽  
pp. 895-898 ◽  
Author(s):  
J A Dawson ◽  
K A Kaiser ◽  
O Affuso ◽  
G R Cutter ◽  
D B Allison
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trials ◽  
Treatment Effects ◽  
Controlled Trials ◽  
Randomized Controlled

scholarly journals Between-centre differences and treatment effects in randomized controlled trials: A case study in traumatic brain injury

Trials ◽  
2011 ◽  
Vol 12 (1) ◽  
Author(s):  
Hester F Lingsma ◽  
Bob Roozenbeek ◽  
Pablo Perel ◽  
Ian Roberts ◽  
Andrew IR Maas ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Randomized Controlled Trials ◽  
Treatment Effects ◽  
Controlled Trials ◽  
Randomized Controlled
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