The Changing Face of Clinical Trials
A collection of articles that examine the current challenges in the design, performance, and interpretation of clinical trials.
Latest Articles on Clinical Trials
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Noninferiority Trials
L. Mauri and R.B. D’Agostino, Sr. N Engl J Med 2017; 377:1357-1367
In this review, the authors consider the characteristics and challenges of noninferiority trial designs, including seven essential features of noninferiority trials.
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Trials in Health Insurance Systems
N.K. Choudhry N Engl J Med 2017; 377:957-964
This review article considers the strengths and weaknesses of randomized clinical trials that are conducted through the analysis of data gathered by health insurers.
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Master Protocols
J. Woodcock and L.M. LaVange N Engl J Med 2017; 377:62-70
This review considers master protocols, which involve the study of one or more interventions in multiple diseases or of a single disease with multiple interventions.
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Partnerships among Researchers, Patient Groups, and Industry
B.W. Ramsey, G.T. Nepom, and S. Lonial N Engl J Med 2017; 376:1762-1769
A growing approach to developing new treatments is a partnership among researchers, patient groups, and industry. This article in the Clinical Trials Series gives three examples of such collaborations.
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An FDA Viewpoint on Medical-Device Clinical Trials
O. Faris and J. Shuren N Engl J Med 2017; 376:1350-1357
Medical devices range from something as simple as an elastic bandage to something as complicated as a deep-brain stimulator. This review describes the FDA approach for understanding and approving medical devices.
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Informed Consent
C. Grady and Others N Engl J Med 2017; 376:856-867
An investigator obtaining informed consent traditionally asks participants to sign a written consent document — an approach that is becoming outdated. This multipart review examines electronic and video informed consent and consent in app-based and Internet-based trials, with videos showing examples.
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Drug-Development Challenges for Small Companies
R.A. Moscicki and P.K. Tandon N Engl J Med 2017; 376:469-474
Small biopharmaceutical companies encounter challenges in designing and implementing clinical development programs. This article discusses the approaches these companies take toward addressing such obstacles.
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The Large Pharmaceutical Company Perspective
M. Rosenblatt N Engl J Med 2017; 376:52-60
The former chief medical officer of a large pharmaceutical company addresses the issue of complexity and how it affects the performance of clinical trials.
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Geographic Variations in Randomized, Controlled Trials
S. Yusuf and J. Wittes N Engl J Med 2016; 375:2263-2271
In large multinational clinical therapeutic trials, responses in one region can differ from those in another. This article examines reasons for such differences and suggests criteria for determining whether the differences are real or the play of chance.
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Lessons from Clinical Trials Involving Hypertension
M.A. Pfeffer and J.J.V. McMurray N Engl J Med 2016; 375:1756-1766
Ethical 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.
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Data Monitoring Committees — Expect the Unexpected
D.L. DeMets and S.S. Ellenberg N Engl J Med 2016; 375:1365-1371
Randomized 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.
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Considerations When the Primary Outcome Is Positive
S.J. Pocock and G.W. Stone N Engl J Med 2016; 375:971-979
When 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.
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The Primary Outcome Fails — What Next?
S.J. Pocock and G.W. Stone N Engl J Med 2016; 375:861-870
When 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.
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Adaptive Designs for Clinical Trials
D.L. Bhatt and C. Mehta N Engl J Med 2016; 375:65-74
Investigators 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.
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Comparative Effectiveness Studies and Patient Care
L.D. Fiore and P.W. Lavori N Engl J Med 2016; 374:2152-2158
Clinical trials of interventions in common practice can be built into the workflow of an electronic medical record. The authors review four such trials and highlight the strengths and weaknesses of this approach to gathering information.
