Revisiting the Commercial–Academic Interface
- May 7, 2015 | Jeffrey M. Drazen, M.D.
- May 7, 2015 | Lisa Rosenbaum, M.D.
- May 14, 2015 | Lisa Rosenbaum, M.D.
- May 21, 2015 | Lisa Rosenbaum, M.D.
- [NEJM 21 May 2015 Vol 372]British Medical JournalMay 20, 2015 | Richard Lehman
- Say It Ain’t So: Logical Fallacies in Defense of Conflicts of Interest … in the New England Journal of Medicine?Healthcare RenewalMay 21, 2015 | Roy Poses, M.D.
- British Medical JournalJune 2, 2015 | Robert Steinbrook, Jerome P Kassirer, and Marcia Angell
- The New England Journal of Medicine goes on an ill advised journeyBritish Medical JournalJune 2, 2015 | Elizabeth Loder, Catherine Brizzell, and Fiona Godlee
- The LancetJune 6, 2015 | Richard Horton
- British Medical JournalJune 11, 2015 | Fiona Godlee
Then, someone sent me a link to this month’s The Large Pharmaceutical Company Perspective about several heroic PHARMA adventures. I noticed it was from a series called The Changing Face of Clinical Trials, so I ran down the rest of the series and read them all. And then I found some other NEJM Clinical Trial Offerings offerings in 2016.
The Changing Face of Clinical Trials
- June 2, 2016 | J. Woodcock and OthersWith this issue, we launch a series of articles that deal with contemporary challenges that affect clinical trialists today. Articles will define a specific issue of interest and illustrate it with examples from actual practice, as well as bring additional history and color to the topic.
- June 2, 2016 | L.D. Fiore and P.W. LavoriInvestigators use adaptive trial designs to alter basic features of an ongoing trial. This approach obtains the most information possible in an unbiased way while putting the fewest patients at risk. In this review, the authors discuss selected issues in adaptive design.
- August 4, 2016 | I. Ford and J. NorrieInvestigators use adaptive trial designs to alter basic features of an ongoing trial. This approach obtains the most information possible in an unbiased way while putting the fewest patients at risk. In this review, the authors discuss selected issues in adaptive design.
- August 4, 2016 | I. Ford and J. NorrieIn pragmatic trials, participants are broadly representative of people who will receive a treatment or diagnostic strategy, and the outcomes affect day-to-day care. The authors review the unique features of pragmatic trials through a wide-ranging series of exemplar trials.
- September 1, 2016 | S.J. Pocock and G.W. StoneWhen the primary outcome of a clinical trial fails to reach its prespecified end point, can any clinically meaningful information still be derived from it? This review article addresses that question.
- September 8, 2016 | S.J. Pocock and G.W. StoneWhen a clinical trial reaches its primary outcome, several issues must be considered before a clinical message is drawn. These issues are reviewed in this article.
- October 6, 2016 | D.L. DeMets and S.S. EllenbergRandomized clinical trials require a mechanism to safeguard the enrolled patients from harm that could result from participation. This article reviews the role of data monitoring committees in the performance of randomized clinical trials.
- November 3, 2016 | M.A. Pfeffer and J.J.V. McMurrayEthical issues can arise in the design and conduct of clinical trials. Using the trials that set the stage for our current treatment of hypertension, the authors show how the changing treatment landscape raised ethical problems as these trials were undertaken.
- January 5, 2017 | M. RosenblattThe former chief medical officer of a large pharmaceutical company addresses the issue of complexity and how it affects the performance of clinical trials.
The Final Rule
- September 16, 2016 | D.A. Zarin and OthersThe final rule for reporting clinical trial results has now been issued by the Department of Health and Human Services. It aims to increase accountability in the clinical research enterprise, making key information available to researchers, funders, and the public.
History of Clinical Trials
- June 2, 2016 | L.E. Bothwell and Others
- July 14, 2016 | A. Rankin and J. Rivest
- August 11, 2016 | L.E. Bothwell and S.H. Podolsky
- Clinical Trials, Healthy Controls, and the IRBSeptember 15, 2016 | L. Stark and J.A. Greene
- Collaborative Clinical TrialsMarch 3, 2011 | A.J. Moss, C.W. Francis, and D. Ryan
- Pragmatic Trials — Guides to Better Patient Care?May 5, 2011 | J.H. Ware and M.B. Hamel
- October 4, 2012 | R.J. Little and Others
- October 24, 2013 | M.M. Mello and Others
- November 27, 2014 | B.L. Strom and Others
- December 25, 2014 | S. Bonini and Others
- January 8, 2015 | D.A. Zarin, T. Tse, and J. Sheehan
- January 15, 2015 | J.M. Drazen
- Adaptive Phase II Trial DesignJuly 7, 2015 | D. Harrington and G. Parmigiani
- August 4, 2015 | The Academic Research Organization Consortium for Continuing Evaluation of Scientific Studies — Cardiovascular (ACCESS CV)
- August 4, 2015 | The International Consortium of Investigators for Fairness in Trial Data Sharing
- August 4, 2015 | H.M. Krumholz and J. Waldstreicher
- January 21, 2016 | Dan L. Longo, and Jeffrey M. Drazen
- August 4, 2016 | E. Warren
- September 22, 2016 | F. Rockhold, P. Nisen, and A. Freeman
- September 22, 2016 | B. Lo and D.L. DeMets
- September 22, 2016 | R.L. Grossman and Others
- October 27, 2016 | B.L. Strom and Others