Featured Research

from universities, journals, and other organizations

Patient safety reporting and drug label accuracy missing vital information, expert says

Date:
March 11, 2010
Source:
Memorial Sloan-Kettering Cancer Center
Summary:
An expert calls for change in the way researchers and pharmaceutical companies collect and report adverse symptom information in clinical trials submitted to the Food and Drug Administration, and how the FDA represents this information on drug labels.

A Perspective piece in the New England Journal of Medicine calls for change in the way researchers and pharmaceutical companies collect and report adverse symptom information in clinical trials submitted to the Food and Drug Administration (FDA), and how the FDA represents this information on drug labels.

Related Articles


Ethan Basch, MD, outcomes researcher and medical oncologist at Memorial Sloan-Kettering Cancer Center, recommends that fundamental change is necessary in order to improve the process of evaluating the true toxicity of drugs. Dr. Basch has found that clinicians -- the current responsible party for collecting and reporting symptoms in clinical trials -- systematically miss important symptoms and often underestimate the severity of the symptoms they do notice. According to Basch, this leads to under-reporting of adverse events and, consequently to clinical trial results, publications, and drug labels that don't adequately represent the true toxicity of drugs.

To provide researchers, clinicians, and patients with more usable and valuable symptom information, Dr. Basch, who works closely with the FDA and National Cancer Institute on research issues, suggests that patients be given the tools to self-report adverse symptoms in clinical trials and online reporting between clinic visits, which can assist nurses and doctors with symptom management and improve communication.

According to Dr. Basch, "Patient self-reporting enhances the quality and comprehensiveness of symptom and adverse event data," and he notes that "patients must be given a voice in healthcare delivery, research, and regulatory processes, as they are the most important stakeholders and deserve access to the impressions of their peers when trying to decide whether to start a new treatment."


Story Source:

The above story is based on materials provided by Memorial Sloan-Kettering Cancer Center. Note: Materials may be edited for content and length.


Journal Reference:

  1. Ethan Basch. The Missing Voice of Patients in Drug-Safety Reporting. New England Journal of Medicine, 2010; 362 (10): 865 DOI: 10.1056/NEJMp0911494

Cite This Page:

Memorial Sloan-Kettering Cancer Center. "Patient safety reporting and drug label accuracy missing vital information, expert says." ScienceDaily. ScienceDaily, 11 March 2010. <www.sciencedaily.com/releases/2010/03/100310175136.htm>.
Memorial Sloan-Kettering Cancer Center. (2010, March 11). Patient safety reporting and drug label accuracy missing vital information, expert says. ScienceDaily. Retrieved April 21, 2015 from www.sciencedaily.com/releases/2010/03/100310175136.htm
Memorial Sloan-Kettering Cancer Center. "Patient safety reporting and drug label accuracy missing vital information, expert says." ScienceDaily. www.sciencedaily.com/releases/2010/03/100310175136.htm (accessed April 21, 2015).

Share This


More From ScienceDaily



More Science & Society News

Tuesday, April 21, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Yemen Doctors at Breaking Point

Yemen Doctors at Breaking Point

Reuters - News Video Online (Apr. 21, 2015) — A Sanaa hospital struggles to cope with the high number of casualties with severe injuries, after an air strike left at least 25 dead and hundreds wounded. Deborah Lutterbeck reports. Video provided by Reuters
Powered by NewsLook.com
Labour Party Warns Britain's Health Service 'on Life Support'

Labour Party Warns Britain's Health Service 'on Life Support'

AFP (Apr. 20, 2015) — Britain&apos;s opposition Labour Party Monday claimed the National Health Service (NHS) was &apos;on life support&apos; as it turned its attention to the state-run service, which is a key issue for the UK&apos;s May 7 general election. Video provided by AFP
Powered by NewsLook.com
Pending Comcast-Time Warner Merger Has DOJ, FCC Concerned

Pending Comcast-Time Warner Merger Has DOJ, FCC Concerned

Newsy (Apr. 20, 2015) — The Department of Justice reportedly has concerns a Time Warner-Comcast merger would create an entity too large in the cable and broadband markets. Video provided by Newsy
Powered by NewsLook.com
Five Years Later, the BP Oil Spill Is Still Taking Its Toll

Five Years Later, the BP Oil Spill Is Still Taking Its Toll

AFP (Apr. 20, 2015) — On April 20, 2010, an explosion and fire on the Deepwater Horizon rig in the Gulf of Mexico started the biggest oil spill in US history. BP recently reported the Gulf is recovering well, but scientists paint a different picture. Duration: 02:36 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Science & Society

Business & Industry

Education & Learning

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins