Literature DB >> 29808341

Conditional power as an aid in making interim decisions in observational studies.

Alexander Muir Walker1.   

Abstract

Conditional power combines the findings of a partially completed study with assumptions about the future. The goal is to estimate the probability that the eventual study result will be incompatible with a criterion value, such as acceptable risk or the null hypothesis. Some history and motivation for conditional power calculations are provided, with examples illustrating the application to drug safety studies. This is an expository article suggesting that conditional power, which is well-established in clinical trials research, also has application to observational studies. The utility may be highest in regulatory settings where resources are limited and interim decisions have to be made accurately in the shortest possible time.

Entities:  

Keywords:  Curtailed testing; Stochastic curtailment; Study management; Unplanned termination

Mesh:

Year:  2018        PMID: 29808341     DOI: 10.1007/s10654-018-0413-9

Source DB:  PubMed          Journal:  Eur J Epidemiol        ISSN: 0393-2990            Impact factor:   8.082


  19 in total

1.  Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data.

Authors:  Jennifer C Nelson; Andrea J Cook; Onchee Yu; Clara Dominguez; Shanshan Zhao; Sharon K Greene; Bruce H Fireman; Steven J Jacobsen; Eric S Weintraub; Lisa A Jackson
Journal:  Pharmacoepidemiol Drug Saf       Date:  2012-01       Impact factor: 2.890

Review 2.  When is enough evidence enough? - Using systematic decision analysis and value-of-information analysis to determine the need for further evidence.

Authors:  Uwe Siebert; Ursula Rochau; Karl Claxton
Journal:  Z Evid Fortbild Qual Gesundhwes       Date:  2013-11-12

3.  The Coronary Drug Project. Findings leading to discontinuation of the 2.5-mg day estrogen group. The coronary Drug Project Research Group.

Authors: 
Journal:  JAMA       Date:  1973-11-05       Impact factor: 56.272

4.  The Coronary Drug Project. Initial findings leading to modifications of its research protocol.

Authors: 
Journal:  JAMA       Date:  1970-11-16       Impact factor: 56.272

5.  The Fate of FDA Postapproval Studies.

Authors:  Steven Woloshin; Lisa M Schwartz; Brian White; Thomas J Moore
Journal:  N Engl J Med       Date:  2017-09-21       Impact factor: 91.245

6.  Sequential surveillance for drug safety in a regulatory environment.

Authors:  David Martin; Joshua J Gagne; Susan Gruber; Rima Izem; Jennifer C Nelson; Michael D Nguyen; Rita Ouellet-Hellstrom; Sebastian Schneeweiss; Sengwee Toh; Alexander M Walker
Journal:  Pharmacoepidemiol Drug Saf       Date:  2018-03-05       Impact factor: 2.890

7.  Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance.

Authors:  I R Silva; M Kulldorff
Journal:  Biometrics       Date:  2015-05-22       Impact factor: 2.571

8.  Practical aspects of decision making in clinical trials: the coronary drug project as a case study. The Coronary Drug Project Research Group.

Authors: 
Journal:  Control Clin Trials       Date:  1981-05

9.  Expected value of sample information calculations in medical decision modeling.

Authors:  A E Ades; G Lu; K Claxton
Journal:  Med Decis Making       Date:  2004 Mar-Apr       Impact factor: 2.583

10.  A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data.

Authors:  Jennifer C Nelson; Robert Wellman; Onchee Yu; Andrea J Cook; Judith C Maro; Rita Ouellet-Hellstrom; Denise Boudreau; James S Floyd; Susan R Heckbert; Simone Pinheiro; Marsha Reichman; Azadeh Shoaibi
Journal:  EGEMS (Wash DC)       Date:  2016-09-06
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  1 in total

1.  To stop or not to stop: a value of information view.

Authors:  Uwe Siebert; Lára R Hallsson
Journal:  Eur J Epidemiol       Date:  2018-08-17       Impact factor: 8.082

  1 in total

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