Featured Research

from universities, journals, and other organizations

Approaches to pain assessment in cancer clinical trials

Date:
December 5, 2013
Source:
University of North Carolina School of Medicine
Summary:
Researchers have developed guidelines to help drug developers include meaningful pain endpoints when designing cancer trials.

Pain is a common symptom and can be debilitating for patients with cancer. Clinically significant improvements in pain resulting from a cancer treatment can support drug approval and labeling claims in the United States, when it is adequately measured. Different approaches have been used for measuring pain in cancer clinical trials, with varying levels of rigor.

A new paper published by Cancer External Site describes approaches to pain measurement used in oncology clinical trials submitted to the U.S. Food and Drug Administration that are consistent with current FDA guidance principles. The purpose of the paper is to assist drug developers to include meaningful pain endpoints when designing cancer trials.

"Measurement of pain and other symptoms is an essential part of cancer trials. Without this information, our understanding of how drugs affect people is incomplete," said lead author Ethan Basch, MD, Director of the Cancer Outcomes Research Program at the University of North Carolina Lineberger Comprehensive Cancer Center. Dr. Basch developed the paper with FDA colleagues while serving as a Guest Worker at the FDA.

The paper outlines several areas that are commonly a challenge in pain analyses, including measuring pain and analgesic use, how to collect pain information from patients, and how to define pain improvements. Examples of how the challenges have been addressed in past trials are provided.


Story Source:

The above story is based on materials provided by University of North Carolina School of Medicine. Note: Materials may be edited for content and length.


Journal Reference:

  1. Ethan Basch, Ann Marie Trentacosti, Laurie B. Burke, Virginia Kwitkowski, Robert C. Kane, Karen A. Autio, Elektra Papadopoulos, James P. Stansbury, Paul G. Kluetz, Harry Smith, Robert Justice, Richard Pazdur. Pain palliation measurement in cancer clinical trials: The US Food and Drug Administration perspective. Cancer, 2013; DOI: 10.1002/cncr.28470

Cite This Page:

University of North Carolina School of Medicine. "Approaches to pain assessment in cancer clinical trials." ScienceDaily. ScienceDaily, 5 December 2013. <www.sciencedaily.com/releases/2013/12/131205165721.htm>.
University of North Carolina School of Medicine. (2013, December 5). Approaches to pain assessment in cancer clinical trials. ScienceDaily. Retrieved July 31, 2014 from www.sciencedaily.com/releases/2013/12/131205165721.htm
University of North Carolina School of Medicine. "Approaches to pain assessment in cancer clinical trials." ScienceDaily. www.sciencedaily.com/releases/2013/12/131205165721.htm (accessed July 31, 2014).

Share This




More Health & Medicine News

Thursday, July 31, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

House Republicans Vote to Sue Obama Over Healthcare Law

House Republicans Vote to Sue Obama Over Healthcare Law

Reuters - US Online Video (July 31, 2014) The Republican-led House of Representatives votes to sue President Obama, accusing him of overstepping his executive authority in making changes to the Affordable Care Act. Mana Rabiee reports. Video provided by Reuters
Powered by NewsLook.com
Despite Health Questions, E-Cigs Are Beneficial: Study

Despite Health Questions, E-Cigs Are Beneficial: Study

Newsy (July 31, 2014) Citing 81 previous studies, new research out of London suggests the benefits of smoking e-cigarettes instead of regular ones outweighs the risks. Video provided by Newsy
Powered by NewsLook.com
Dangerous Bacteria Kills One in Florida

Dangerous Bacteria Kills One in Florida

AP (July 31, 2014) Sarasota County, Florida health officials have issued a warning against eating raw oysters and exposing open wounds to coastal and inland waters after a dangerous bacteria killed one person and made another sick. (July 31) Video provided by AP
Powered by NewsLook.com
Health Insurers' Profits Slide

Health Insurers' Profits Slide

Reuters - Business Video Online (July 30, 2014) Obamacare-related costs were said to be behind the profit plunge at Wellpoint and Humana, but Wellpoint sees the new exchanges boosting its earnings for the full year. Fred Katayama reports. Video provided by Reuters
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