Literature DB >> 25856591

Selecting the right tool for the job.

Arthur L Caplan1, Carolyn Plunkett, Bruce Levin.   

Abstract

There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical and consistent with prevailing norms governing human subjects research. Some maintain that only randomized controlled trials (RCTs) with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs.

Entities:  

Keywords:  Ebola treatment trials; adaptive trial design; cluster randomized designs; compassionate access; elimination of inferior treatments; expanded access; international research; placebo controls; randomized controlled trials (RCT); research ethics; selection trials; sequential designs; standard of care controls

Mesh:

Year:  2015        PMID: 25856591      PMCID: PMC5572069          DOI: 10.1080/15265161.2015.1010993

Source DB:  PubMed          Journal:  Am J Bioeth        ISSN: 1526-5161            Impact factor:   11.229


  10 in total

1.  Evaluating Ebola therapies--the case for RCTs.

Authors:  Edward Cox; Luciana Borio; Robert Temple
Journal:  N Engl J Med       Date:  2014-12-03       Impact factor: 91.245

2.  Infectious Diseases. Ebola vaccine trials raise ethical issues.

Authors:  Jon Cohen; Kai Kupferschmidt
Journal:  Science       Date:  2014-10-17       Impact factor: 47.728

Review 3.  Ethical considerations of experimental interventions in the Ebola outbreak.

Authors:  Annette Rid; Ezekiel J Emanuel
Journal:  Lancet       Date:  2014-08-22       Impact factor: 79.321

4.  Evaluating novel therapies during the Ebola epidemic.

Authors:  Steven Joffe
Journal:  JAMA       Date:  2014-10-01       Impact factor: 56.272

5.  Adverse event management in mass drug administration for neglected tropical diseases.

Authors:  Arthur Caplan; Amanda Zink
Journal:  Clin Ther       Date:  2014-03-06       Impact factor: 3.393

6.  Subversive subjects: rule-breaking and deception in clinical trials.

Authors:  Rebecca Dresser
Journal:  J Law Med Ethics       Date:  2013       Impact factor: 1.718

Review 7.  Rebellion against the polio vaccine in Nigeria: implications for humanitarian policy.

Authors:  Cecilia Chen
Journal:  Afr Health Sci       Date:  2004-12       Impact factor: 0.927

8.  Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop.

Authors:  Christopher S Coffey; Bruce Levin; Christina Clark; Cate Timmerman; Janet Wittes; Peter Gilbert; Sara Harris
Journal:  Clin Trials       Date:  2012-12       Impact factor: 2.486

9.  Results of a phase II open-label, non-randomized trial of cisplatin chemotherapy in patients with BRCA1-positive metastatic breast cancer.

Authors:  Tomasz Byrski; Rebecca Dent; Pawel Blecharz; Malgorzata Foszczynska-Kloda; Jacek Gronwald; Tomasz Huzarski; Cezary Cybulski; Elzbieta Marczyk; Robert Chrzan; Andrea Eisen; Jan Lubinski; Steven A Narod
Journal:  Breast Cancer Res       Date:  2012-07-20       Impact factor: 6.466

10.  Randomised controlled trials for Ebola: practical and ethical issues.

Authors:  Clement Adebamowo; Oumou Bah-Sow; Fred Binka; Roberto Bruzzone; Arthur Caplan; Jean-François Delfraissy; David Heymann; Peter Horby; Pontiano Kaleebu; Jean-Jacques Muyembe Tamfum; Piero Olliaro; Peter Piot; Abdul Tejan-Cole; Oyewale Tomori; Aissatou Toure; Els Torreele; John Whitehead
Journal:  Lancet       Date:  2014-10-13       Impact factor: 79.321

  10 in total
  14 in total

1.  The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials.

Authors:  Mary Jane Welch; Rachel Lally; Jennifer E Miller; Stephanie Pittman; Lynda Brodsky; Arthur L Caplan; Gina Uhlenbrauck; Darcy M Louzao; James H Fischer; Benjamin Wilfond
Journal:  Clin Trials       Date:  2015-09-15       Impact factor: 2.486

Review 2.  From bench to almost bedside: the long road to a licensed Ebola virus vaccine.

Authors:  Gary Wong; Emelissa J Mendoza; Francis A Plummer; George F Gao; Gary P Kobinger; Xiangguo Qiu
Journal:  Expert Opin Biol Ther       Date:  2017-11-17       Impact factor: 4.388

Review 3.  Treating the host response to emerging virus diseases: lessons learned from sepsis, pneumonia, influenza and Ebola.

Authors:  David S Fedson
Journal:  Ann Transl Med       Date:  2016-11

4.  Rigorous Clinical Trial Design in Public Health Emergencies Is Essential.

Authors:  Susan S Ellenberg; Gerald T Keusch; Abdel G Babiker; Kathryn M Edwards; Roger J Lewis; Jens D Lundgren; Charles D Wells; Fred Wabwire-Mangen; Keith P W J McAdam
Journal:  Clin Infect Dis       Date:  2018-04-17       Impact factor: 9.079

5.  Vaccine testing for emerging infections: the case for individual randomisation.

Authors:  Nir Eyal; Marc Lipsitch
Journal:  J Med Ethics       Date:  2017-04-10       Impact factor: 2.903

6.  A post hoc evaluation of a sample size re-estimation in the Secondary Prevention of Small Subcortical Strokes study.

Authors:  Leslie A McClure; Jeff M Szychowski; Oscar Benavente; Robert G Hart; Christopher S Coffey
Journal:  Clin Trials       Date:  2016-04-19       Impact factor: 2.486

Review 7.  Critical role of ethics in clinical management and public health response to the West Africa Ebola epidemic.

Authors:  Morenike O Folayan; Bridget G Haire; Brandon Brown
Journal:  Risk Manag Healthc Policy       Date:  2016-05-12

8.  Ebola vaccine development plan: ethics, concerns and proposed measures.

Authors:  Morenike Oluwatoyin Folayan; Aminu Yakubu; Bridget Haire; Kristin Peterson
Journal:  BMC Med Ethics       Date:  2016-02-08       Impact factor: 2.652

9.  The Ebola clinical trials: a precedent for research ethics in disasters.

Authors:  Philippe Calain
Journal:  J Med Ethics       Date:  2016-08-29       Impact factor: 2.903

10.  The ethics of using placebo in randomised controlled trials: a case study of a Plasmodium vivax antirelapse trial.

Authors:  Phaik Yeong Cheah; Norbert Steinkamp; Lorenz von Seidlein; Ric N Price
Journal:  BMC Med Ethics       Date:  2018-03-06       Impact factor: 2.652

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