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Literature DB >> 23658242

Ethics, error, and initial trials of efficacy.

Spencer Phillips Hey¹, Jonathan Kimmelman.

Abstract

Clinical trial reforms aimed at boosting phase 2 positive predictivity may involve ethical and social trade-offs.

Mesh：

Year: 2013 PMID： 23658242 PMCID： PMC4516405 DOI： 10.1126/scitranslmed.3005684

Source DB: PubMed Journal: Sci Transl Med ISSN： 1946-6234 Impact factor: 17.956

18 in total

1. An examination of the relative impact of type I and type II error rates in phase II drug screening trial queues.

Authors: Alan D Hutson; Gregory E Wilding
Journal: Pharm Stat Date: 2012-01-10 Impact factor: 1.894

2. Extending clinical equipoise to phase 1 trials involving patients: unresolved problems.

Authors: James A Anderson; Jonathan Kimmelman
Journal: Kennedy Inst Ethics J Date: 2010-03

3. Should terminally ill patients have access to phase I drugs?

Authors: Nellie Bristol
Journal: Lancet Date: 2007-03-10 Impact factor: 79.321

Review 4. Other paradigms: better treatments are identified by better trials: the value of randomized phase II studies.

Authors: Manish R Sharma; Michael L Maitland; Mark J Ratain
Journal: Cancer J Date: 2009 Sep-Oct Impact factor: 3.360

Review 5. Experimental human challenge infections can accelerate clinical malaria vaccine development.

Authors: Robert W Sauerwein; Meta Roestenberg; Vasee S Moorthy
Journal: Nat Rev Immunol Date: 2011-01 Impact factor: 53.106

Review 6. Optimism bias leads to inconclusive results-an empirical study.

Authors: Benjamin Djulbegovic; Ambuj Kumar; Anja Magazin; Anneke T Schroen; Heloisa Soares; Iztok Hozo; Mike Clarke; Daniel Sargent; Michael J Schell
Journal: J Clin Epidemiol Date: 2010-12-16 Impact factor: 6.437

7. Research ethics. Beyond access vs. protection in trials of innovative therapies.

Authors: Alex John London; Jonathan Kimmelman; Marina Elena Emborg
Journal: Science Date: 2010-05-14 Impact factor: 47.728

8. Some design issues in phase 2B vs phase 3 prevention trials for testing efficacy of products or concepts.

Authors: Peter B Gilbert
Journal: Stat Med Date: 2010-05-10 Impact factor: 2.373

Review 9. Improving the design of phase II trials of cytostatic anticancer agents.

Authors: Andrew Stone; Catherine Wheeler; Alan Barge
Journal: Contemp Clin Trials Date: 2006-07-14 Impact factor: 2.226

10. Predicting harms and benefits in translational trials: ethics, evidence, and uncertainty.

Authors: Jonathan Kimmelman; Alex John London
Journal: PLoS Med Date: 2011-03-08 Impact factor: 11.069

1 in total

Review 1. Inefficiencies and Patient Burdens in the Development of the Targeted Cancer Drug Sorafenib: A Systematic Review.

Authors: James Mattina; Benjamin Carlisle; Yasmina Hachem; Dean Fergusson; Jonathan Kimmelman
Journal: PLoS Biol Date: 2017-02-03 Impact factor: 8.029

1 in total