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.

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 23, 2014 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 23, 2014).

Share This



More Science & Society News

Wednesday, April 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

High Court to Hear Dispute of TV Over Internet

High Court to Hear Dispute of TV Over Internet

AP (Apr. 22, 2014) The future of Aereo, an online service that provides over-the-air TV channels, hinges on a battle with broadcasters that goes before the U.S. Supreme Court on Tuesday. (April 22) Video provided by AP
Powered by NewsLook.com
Is North Korea Planning Nuclear Test #4?

Is North Korea Planning Nuclear Test #4?

Newsy (Apr. 22, 2014) South Korean officials say North Korea is preparing to conduct another nuclear test, but is Pyongyang just bluffing this time? Video provided by Newsy
Powered by NewsLook.com
Iowa College Finds Beauty in Bulldogs

Iowa College Finds Beauty in Bulldogs

AP (Apr. 22, 2014) Drake University hosts 35th annual Beautiful Bulldog Contest. (April 21) Video provided by AP
Powered by NewsLook.com
Sorry, Guys, Only Women Can Make Their Voices Sound Sexier

Sorry, Guys, Only Women Can Make Their Voices Sound Sexier

Newsy (Apr. 21, 2014) According to researchers at Albright College, women have the ability to make their voices sound sexier, but men don't. Video provided by Newsy
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:
from the past week

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