Proof of principle studies

  title={Proof of principle studies},
  author={Bernd Schmidt},
  journal={Epilepsy Research},
  • B. Schmidt
  • Published 31 January 2006
  • Psychology
  • Epilepsy Research
Frameworks for Proof-of-Concept Clinical Trials of Interventions That Target Fundamental Aging Processes
This article summarizes the outcomes of an international meeting partly funded through the NIH R24 Geroscience Network, whose purpose was to generate concepts and frameworks for early, proof-of-concept clinical trials for therapeutic interventions that target fundamental processes of aging.
A Bayesian Method for the Detection of Proof of Concept in Early Phase Oncology Studies with a Basket Design
A novel approach for PoC detection in the early phase basket trials under a Bayesian framework is proposed, and results show that the proposed approach has a promising performance, with considerable gain in power compared with the independent approach when a relatively large number of the cancer types are sensitive to the treatment.
Proof‐of‐Principle/Proof‐of‐Concept Trials in Drug Development
The biomarkers, pharmacogenomics, proteomics, metabonomics, medical imaging, pharmacological models, and nonpharmacological models in PoP/PoC trials are focused on.
Exenatide and the treatment of patients with Parkinson's disease.
These results demonstrate a potential cost-efficient approach through which preliminary clinical data of possible biological effects are obtainable, prior to undertaking the major investment required for double-blind trials of a potential disease-modifying drug in PD.
Clinical development of antiepileptic drugs in adults
  • B. Schmidt
  • Medicine, Psychology
  • 2011
Exenatide as a novel treatment for Parkinson's Disease
The aim of this thesis is the evaluation of Exenatide’s possible role as a potential neuroprotective/disease modifying agent in PD with only preliminary insights regarding its mechanisms of action in neurodegeneration.
Drugs’ development in acute heart failure: what went wrong?
This review has reviewed the data published on drugs developed for AHF since early 2000s, trying to recognise factors that have worked for a successful approval or for the stoppage of the program, in an attempt to delineate future trajectories forAHF drug development.
Efficacy and Safety of Pirfenidone in Patients with Second-Degree Burns: A Proof-of-Concept Randomized Controlled Trial
A decrease in wound healing time by enhancing wound re-epithelialization was observed with pirfenidone, and Histologic evaluations showed less wound fibrosis in the pirfenodone group.


Proof of principle trials: EEG surrogate endpoints
  • C. Binnie
  • Biology, Medicine
    Epilepsy Research
  • 2001
A new approach in anti‐epileptic drug evaluation
A complete withdrawal of AEDs should be avoided and a titration phase limited to 3 days is suggested, using a condensed evaluation setting including the TISA method, serum concentration and neuropsychological monitoring, by which AED efficacy on seizure activity can be objectively quantified by using continuous video‐EEG monitoring.
Transcranial magnetic stimulation (TMS)
Professional Institutional Original Effective Date: November 1, 2011 Original Effective Date: November 1, 2011 Revision Date(s): December 7, 2012; May 7, 2013; October 15, 2014; March 18, 2015;