0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Commentary |

The European Medicines Agency and the Brave New World of Access to Clinical Trial Data

Robert Steinbrook, MD
JAMA Intern Med. 2013;173(5):373-374. doi:10.1001/jamainternmed.2013.3842.
Text Size: A A A
Published online

Extract

As of January 2014, the European Medicines Agency (EMA) will publish clinical trial data for the medications it considers for approval.1 After the marketing authorization process is complete, researchers and others who are independent of the sponsors of studies, the authors of journal reports, and regulatory agencies should be able to review complete study information, including anonymized data at the patient level, reanalyze the data, and conduct new analyses. If the EMA fulfills its promises, a new era of clinical trial data as a public good will begin.2 Data held by the agency will be available regardless of whether a trial is sponsored by industry, a medical research agency, or a foundation or initiated by investigators.

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

First Page Preview

View Large
First page PDF preview

First Page Preview

View Large
First page PDF preview

Figures

Tables

References

Correspondence

CME
Also 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.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
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.
Submit a Comment

Multimedia

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

Web of Science® Times Cited: 3

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

Related Content

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

See Also...
Articles Related By Topic
Related Collections
Jobs
JAMAevidence.com

Users' Guides to the Medical Literature
Chapter 11.3. Dealing With Misleading Presentations of Clinical Trial Results

Users' Guides to the Medical Literature
Introduction

brightcove.createExperiences();