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pagetitle: Bayesian Trials
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#  Scott Berry 2017-07-14
Carl, Lilly ran a phase II/III Bayesian trial for its diabetes drug, Trulicity.  Was a Bayesian phase II trial design, which picked 1 or 2 doses based on a Bayesian algorithm and continued to phase III with the selected doses.  The seamless switch also started other phase III trials.  This is a nice example because it has FDA approval and Lilly states it saved them 12-18 months, with $337M last quarter; exceeding projections of $1.2B/year, and of course the year plus savings is not small.  A bigger story is that the phase II used 7 doses and response adaptive randomization, rather than the preplanned 3 doses.  They may have ended with a dose they would never have explored.  Two papers attached.
Ferring is running a sepsis trial with a Bayesian adaptive phase II which could drop arms and move to phase III.  Trial still ongoing.  
ClinicalTrials.gov Identifier:
NCT02508649

https://clinicaltrials.gov/ct2/show/NCT02508649?term=Sepsis-act&cond=Sepsis&rank=1

A paper about this paper should be coming out soon. 

* Hypothermia in cardiac arrest ICE CAP trial
* CDER approved PROMISE Statin trial ?

# [Natasha Muhlemann](mailto:natalia.muhlemann@cytel.com)
As agreed, I looked briefly at publicly available info on Bayesian designs accepted by FDA. There is a lot in device space, including recent RCT in Lancet, but limited number of examples we could site for CDER/CBER:

* Prevail II (Ebola trial)
* Pfizer COVID vaccine phase 1-2-3 (all Bayesian)
* Eli Lilly Dulaglutide seamless 2/3 – however dose finding was Bayesian but final analysis (ph3) was frequentist
* There is PR by Eli Lilly re their CID in pain treatment accepted by FDA but it mentions master protocol but no info on Bayesian or frequentist – Ross would you know this (I assume it is not sensitive info to share)?
* There are some Bayesian platform trials like ALS (but I don’t know
  if it includes pivotal)
  https://www.massgeneral.org/neurology/als/news/healey-center-launches-first-als-platform-trial-with-5-promising-drugs
  and AGILE Phase 2/3  in glioblastoma https://clinicaltrials.gov/ct2/show/NCT03970447?term=AGILE&draw=2&rank=1
* I would not include REMAP-CAP after recent NEJM article and FDA guidance published last week – it was anyway academic study to my knowledge.