scholarly journals Assessing efficacy in important subgroups in confirmatory trials: An example using Bayesian dynamic borrowing

2021 ◽  
Author(s):  
Nicky Best ◽  
Robert G. Price ◽  
Isabelle J. Pouliquen ◽  
Oliver N. Keene
Keyword(s):  
Confirmatory Trials

scholarly journals Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?

2021 ◽  
pp. 026988112110085
Author(s):  
Robin L Carhart-Harris ◽  
Anne C Wagner ◽  
Manish Agrawal ◽  
Hannes Kettner ◽  
Jerold F Rosenbaum ◽  
...  
Keyword(s):  
Real World ◽  
Best Practice ◽  
Digital Health ◽  
Real World Data ◽  
Treatment Protocols ◽  
World Data ◽  
Cost Efficient ◽  
Personalised Treatment ◽  
New Research ◽  
Confirmatory Trials

Favourable regulatory assessments, liberal policy changes, new research centres and substantial commercial investment signal that psychedelic therapy is making a major comeback. Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice. Here we suggest supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives and digital health solutions to better support the discovery of optimal and personalised treatment protocols and parameters. These recommendations are intended to help support the development of safe, effective and cost-efficient psychedelic therapy, which, given its history, is vulnerable to excesses of hype and regulation.

scholarly journals Confirmatory Trials in the Evaluation of Anticancer Medicinal Products in Man—PFS2: A Measure of Therapeutic Action-At-A-Distance

Neoplasia ◽  
2015 ◽  
Vol 17 (9) ◽  
pp. 716-722 ◽  
Author(s):  
Bryan Oronsky ◽  
Corey A. Carter ◽  
Tony R. Reid ◽  
Jan Scicinski ◽  
Arnold Oronsky ◽  
...  
Keyword(s):  
Therapeutic Action ◽  
Medicinal Products ◽  
Action At A Distance ◽  
Confirmatory Trials

scholarly journals Adaptive enrichment designs for confirmatory trials

2018 ◽  
Vol 38 (4) ◽  
pp. 613-624 ◽  
Author(s):  
Tze Leung Lai ◽  
Philip W. Lavori ◽  
Ka Wai Tsang
Keyword(s):  
Enrichment Designs ◽  
Adaptive Enrichment Designs ◽  
Confirmatory Trials

scholarly journals Subgroup analysis and interpretation for phase 3 confirmatory trials: White paper of the EFSPI/PSI working group on subgroup analysis

2018 ◽  
Vol 18 (2) ◽  
pp. 126-139 ◽  
Author(s):  
Aaron Dane ◽  
Amy Spencer ◽  
Gerd Rosenkranz ◽  
Ilya Lipkovich ◽  
Tom Parke ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Working Group ◽  
White Paper ◽  
Phase 3 ◽  
Confirmatory Trials

scholarly journals Adaptive design of confirmatory trials: Advances and challenges

2015 ◽  
Vol 45 ◽  
pp. 93-102 ◽  
Author(s):  
Tze Leung Lai ◽  
Philip W. Lavori ◽  
Ka Wai Tsang
Keyword(s):  
Adaptive Design ◽  
Confirmatory Trials
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