HOME >> MEDICINE >> NEWS
Experts to address use of patient-reported outcomes in clinical trials at joint Mayo-FDA forum

Dozens of medical research experts will assemble Feb. 23-25, 2006, in Chantilly, Va., to discuss how patient-reported outcomes (PROs) should be developed, validated, interpreted and used in clinical trials. This symposium, jointly sponsored by Mayo Clinic and the U.S. Food and Drug Administration (FDA), is a forum for discussion and feedback regarding the soon-to-be-released FDA draft guidance for industry on using PRO measures to support medical product labeling claims. The draft guidance will be published in the Federal Register with an invitation for public comment.

"Exactly how we incorporate patient-reported outcomes into cancer research has been murky for a long time. It is a great opportunity to bring clarity and consensus to the issue," says Jan Buckner, M.D., Mayo Clinic medical oncologist and chair of the North Central Cancer Treatment Group (NCCTG). The group specializes in researching methods of treating and preventing cancer, as well as methods to alleviate the side effects of cancer and cancer treatments. "Clinicians and researchers around the world are going to be able to use the information presented at this symposium as a guide for how and when to use patient-reported outcomes. It's really a step forward for all of us."

Five writing teams composed of experts in PRO research will present papers on the major themes covered in the draft guidance: conceptual issues; PRO instrument selection; PRO instrument development issues; validation of PROs; and analysis, interpretation and reporting results based on PROs. Each document will include recommendations on the most appropriate methods of how PROs should be incorporated into clinical trials, and will advocate additional research needed to overcome limitations currently faced in the application of PROs. Attendees will have the opportunity to discuss and comment on these papers as well as the FDA's draft guidance.

FDA's experts in PRO measurement in clinical trials also wil
'"/>

Contact: Elizabeth Zimmermann
newsbureau@mayo.edu
507-284-5005
Mayo Clinic
25-Jan-2006


Page: 1 2

Related medicine news :

1. Experts predict Tamiflu could halve the pandemic influenza death toll versus no intervention
2. Experts call for urgent research into anti-epileptic drugs given to children
3. Experts debate role of stenting, bypass surgery in left main coronary artery disease
4. Medicalize me: Experts look at how our perceptions of illness are shaped
5. Experts urge strongest isolation for new drug-resistant tuberculosis cases appearing in South Africa
6. Experts add to growing warnings about asthma drug
7. Experts review current and future approaches to dementia diagnosis
8. Experts present strategies to address adolescent violence and bullying
9. Experts call for balance in addressing under treated pain and drug abuse
10. Experts question prevalent stereotypes about autism
11. Experts call for re-focussing of COPD management to reduce hospital admissions and mortality

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) of Somerset ... of specialty vendors and unique items from across the nation, this holiday-themed event will ... services offered by the VNA. The boutique will be open Saturday, November 4 ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids this ... by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited about ... ages; it is a non-competitive, non-timed event, which is all about having fun and ...
(Date:10/13/2017)... ... ... Talented host, actor Rob Lowe, is introducing a segment ... of "Success Files," which is an award-winning educational program broadcasted on PBS Member ... with passion and integrity. , Sciatica occurs when the sciatic nerve in the ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a ... “The Journey: From the Mountains to the Mission Field” is the creation of published ... all ages and currently teaches a class of ladies at her church, which she ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... 22, 2017  As the latest Obamacare repeal effort ... Cassidy (R-LA) and Lindsey Graham (R-SC) ... medical device industry is in an odd place.  The ... 2.3% excise tax on medical device sales passed along ... covered patients, increased visits and hospital customers with the ...
(Date:9/18/2017)... Pa. and KALAMAZOO, Mich. , Sept. 18, ... , and OptiMed Specialty Pharmacy of ... to offer a strategic hub service that expedites and ... sought-after personal spirometer, Spiro PD 2.0, and wellness management ... spirometer is a medical device used to measure lung ...
(Date:9/12/2017)... Sept. 12, 2017  Consumer reviews on the independent review site ... the number one company for hearing aids, ranking it higher than ... brands. ... #1 by Consumers For Hearing Aids ... Hearing is an online store that provides high performance, state-of-the-art, German-engineered ...
Breaking Medicine Technology:
Cached News: