Literature DB >> 17454416

Articulating and responding to uncertainties in clinical research.

Benjamin Djulbegovic1.   

Abstract

This paper introduces taxonomy of clinical uncertaintes and argues that the choice of scientific method should match the underlying level of uncertainty. Clinical trial is one of these methods aiming to resolve clinical uncertainties. Whenever possible these uncertainties should be quantified. The paper further shows that the still ongoing debate about the usage of "equipoise" vs. "uncertainty principle" vs. "indifference" as an entry criterion to clinical trials actually refers to the question "whose uncertainty counts". This question is intimately linked to the control of research agenda, which is not quantifiable and hence is not solvable to equal acceptability to all interested parties. The author finally shows that there is a predictable relation between [acknowledgement of] uncertainty (the moral principle) on which trials are based and the ultimate outcomes of clinical trials. That is, [acknowledgement of] uncertainty determines a pattern of success in medicine and drives clinical discoveries.

Mesh:

Year:  2007        PMID: 17454416     DOI: 10.1080/03605310701255719

Source DB:  PubMed          Journal:  J Med Philos        ISSN: 0360-5310


  22 in total

1.  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

2.  Rethinking risk assessment for emerging technology first-in-human trials.

Authors:  Anna Genske; Sabrina Engel-Glatter
Journal:  Med Health Care Philos       Date:  2016-03

3.  Uncertainty and equipoise: at interplay between epistemology, decision making and ethics.

Authors:  Benjamin Djulbegovic
Journal:  Am J Med Sci       Date:  2011-10       Impact factor: 2.378

4.  Comparator bias: why comparisons must address genuine uncertainties.

Authors:  Howard Mann; Benjamin Djulbegovic
Journal:  J R Soc Med       Date:  2013-01       Impact factor: 5.344

5.  The risk-escalation model: a principled design strategy for early-phase trials.

Authors:  Spencer Phillips Hey; Jonathan Kimmelman
Journal:  Kennedy Inst Ethics J       Date:  2014-06

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.  Medical research: Trial unpredictability yields predictable therapy gains.

Authors:  Benjamin Djulbegovic; Ambuj Kumar; Paul Glasziou; Branko Miladinovic; Iain Chalmers
Journal:  Nature       Date:  2013-08-22       Impact factor: 49.962

8.  Treatment success in cancer: new cancer treatment successes identified in phase 3 randomized controlled trials conducted by the National Cancer Institute-sponsored cooperative oncology groups, 1955 to 2006.

Authors:  Benjamin Djulbegovic; Ambuj Kumar; Heloisa P Soares; Iztok Hozo; Gerold Bepler; Mike Clarke; Charles L Bennett
Journal:  Arch Intern Med       Date:  2008-03-24

9.  Launching invasive, first-in-human trials against Parkinson's disease: ethical considerations.

Authors:  Jonathan Kimmelman; Alex John London; Bernard Ravina; Tim Ramsay; Mark Bernstein; Alan Fine; Frank W Stahnisch; Marina Elena Emborg
Journal:  Mov Disord       Date:  2009-10-15       Impact factor: 10.338

10.  The paradox of equipoise: the principle that drives and limits therapeutic discoveries in clinical research.

Authors:  Benjamin Djulbegovic
Journal:  Cancer Control       Date:  2009-10       Impact factor: 3.302

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