Literature DB >> 28150789

Consider drug efficacy before first-in-human trials.

Jonathan Kimmelman, Carole Federico.   

Abstract

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Year:  2017        PMID： 28150789     DOI： 10.1038/542025a

Source DB:  PubMed          Journal:  Nature        ISSN： 0028-0836            Impact factor:   49.962


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  10 in total

1.  Replication and reproducibility in spinal cord injury research.

Authors:  Oswald Steward; Phillip G Popovich; W Dalton Dietrich; Naomi Kleitman
Journal:  Exp Neurol       Date:  2011-11-10       Impact factor: 5.330

2.  Assessing risk/benefit for trials using preclinical evidence: a proposal.

Authors:  Jonathan Kimmelman; Valerie Henderson
Journal:  J Med Ethics       Date:  2015-10-13       Impact factor: 2.903

Review 3.  Animal models and the prediction of efficacy in clinical trials of analgesic drugs: a critical appraisal and call for uniform reporting standards.

Authors:  Andrew S C Rice; Dorothy Cimino-Brown; James C Eisenach; Vesa K Kontinen; Michael L Lacroix-Fralish; Ian Machin; Jeffrey S Mogil; Thomas Stöhr
Journal:  Pain       Date:  2008-09-23       Impact factor: 6.961

4.  First-in-Human Clinical Trials - What We Can Learn from Tragic Failures.

Authors:  Sergio Bonini; Guido Rasi
Journal:  N Engl J Med       Date:  2016-11-03       Impact factor: 91.245

5.  Preclinical research: Make mouse studies work.

Authors:  Steve Perrin
Journal:  Nature       Date:  2014-03-27       Impact factor: 49.962

6.  Policy: Global standards for stem-cell research.

Authors:  Jonathan Kimmelman; Insoo Hyun; Nissim Benvenisty; Timothy Caulfield; Helen E Heslop; Charles E Murry; Douglas Sipp; Lorenz Studer; Jeremy Sugarman; George Q Daley
Journal:  Nature       Date:  2016-05-19       Impact factor: 49.962

Review 7.  Risks of phase I research with healthy participants: A systematic review.

Authors:  Rebecca A Johnson; Annette Rid; Ezekiel Emanuel; David Wendler
Journal:  Clin Trials       Date:  2015-09-08       Impact factor: 2.486

8.  Costs and benefits of the national cancer institute central institutional review board.

Authors:  Todd H Wagner; Christine Murray; Jacquelyn Goldberg; Jeanne M Adler; Jeffrey Abrams
Journal:  J Clin Oncol       Date:  2009-10-19       Impact factor: 44.544

Review 9.  Current status of neuroprotection for cerebral ischemia: synoptic overview.

Authors:  Myron D Ginsberg
Journal:  Stroke       Date:  2008-12-08       Impact factor: 7.914

10.  A meta-analysis of threats to valid clinical inference in preclinical research of sunitinib.

Authors:  Valerie C Henderson; Nadine Demko; Amanda Hakala; Nathalie MacKinnon; Carole A Federico; Dean Fergusson; Jonathan Kimmelman
Journal:  Elife       Date:  2015-10-13       Impact factor: 8.140
  10 in total
  19 in total

1.  Preclinical efficacy in therapeutic area guidelines from the U.S. Food and Drug Administration and the European Medicines Agency: a cross-sectional study.

Authors:  Holger Langhof; William Wei Lim Chin; Susanne Wieschowski; Carole Federico; Jonathan Kimmelman; Daniel Strech
Journal:  Br J Pharmacol       Date:  2018-10-01       Impact factor: 8.739

2.  Ex vivo toxicological evaluation of experimental anticancer gold(i) complexes with lansoprazole-type ligands.

Authors:  Natalia Estrada-Ortiz; Elena Lopez-Gonzales; Ben Woods; Stefan Stürup; Inge A M de Graaf; Geny M M Groothuis; Angela Casini
Journal:  Toxicol Res (Camb)       Date:  2019-09-20       Impact factor: 3.524

Review 3.  Applications of tumor chip technology.

Authors:  Stephanie J Hachey; Christopher C W Hughes
Journal:  Lab Chip       Date:  2018-09-26       Impact factor: 6.799

Review 4.  Tissue chips - innovative tools for drug development and disease modeling.

Authors:  L A Low; D A Tagle
Journal:  Lab Chip       Date:  2017-09-12       Impact factor: 6.799

5.  A New Ethical Framework for Assessing the Unique Challenges of Fetal Therapy Trials.

Authors:  Saskia Hendriks; Christine Grady; David Wasserman; David Wendler; Diana W Bianchi; Benjamin E Berkman
Journal:  Am J Bioeth       Date:  2021-01-16       Impact factor: 11.229

6.  Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment?

Authors:  Susanne Wieschowski; William Wei Lim Chin; Carole Federico; Sören Sievers; Jonathan Kimmelman; Daniel Strech
Journal:  PLoS Biol       Date:  2018-04-05       Impact factor: 8.029

Review 7.  Challenges and Promises for Planning Future Clinical Research Into Bacteriophage Therapy Against Pseudomonas aeruginosa in Cystic Fibrosis. An Argumentative Review.

Authors:  Martina Rossitto; Ersilia V Fiscarelli; Paola Rosati
Journal:  Front Microbiol       Date:  2018-05-04       Impact factor: 5.640

8.  The bench is closer to the bedside than we think: Uncovering the ethical ties between preclinical researchers in translational neuroscience and patients in clinical trials.

Authors:  Mark Yarborough; Annelien Bredenoord; Flavio D'Abramo; Nanette C Joyce; Jonathan Kimmelman; Ubaka Ogbogu; Emily Sena; Daniel Strech; Ulrich Dirnagl
Journal:  PLoS Biol       Date:  2018-06-06       Impact factor: 8.029

9.  Open questions for harnessing autophagy-modulating drugs in the SARS-CoV-2 war: hope or hype?

Authors:  Patrick Brest; Jonathan Benzaquen; Daniel J Klionsky; Paul Hofman; Baharia Mograbi
Journal:  Autophagy       Date:  2020-06-19       Impact factor: 16.016

Review 10.  The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

Authors:  Roger A Barker; Melissa K Carpenter; Stuart Forbes; Steven A Goldman; Catriona Jamieson; Charles E Murry; Jun Takahashi; Gordon Weir
Journal:  Stem Cell Reports       Date:  2018-05-08       Impact factor: 7.765
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