0
ARTICLE |

Postmarketing Studies of Drug Efficacy

Brian L. Strom, MD, MPH; Kenneth L. Melmon, MD; Olli S. Miettinen, MD, PhD
Arch Intern Med. 1985;145(10):1791-1794. doi:10.1001/archinte.1985.00360100051005.
Text Size: A A A
Published online

New drugs are subjected to three phases of human testing, beyond animal testing, before they can be approved for marketing in the United States. Included must be at least some randomized clinical trials (RCTs), conducted to test both the efficacy and safety of the drug when given at a particular dosage for a particular indication.1 Generally, between 500 and 3,000 patients are exposed to a drug prior to marketing. Clearly, such premarketing testing does not provide absolute assurance of safety, as demonstrated by the frequent postmarketing discoveries of adverse effects.2,3 This has led to greater emphasis on postmarketing surveillance.2-7 Yet, the presumption persists that premarketing testing assures efficacy, ie, that an approved drug does tend to produce its intended effect. A recent series of articles questions this presumption, however, raising concerns about whether studies of efficacy should also be included as part of postmarketing research8-10 and,

Topics

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

First Page Preview

View Large
/>
First page PDF preview

Figures

Tables

References

Correspondence

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).
Submit a Comment

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 13

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

Jobs
brightcove.createExperiences();