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U.S. Food and Drug Administration (FDA), is a forum for discussion and feedback regarding the soon-to-be-released FDA draft guidance for industry on using PRO measures to support medical product labeling claims. The draft guidance will be published in the Federal Register with an invitation for public comment.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Five writing teams composed of experts in PRO research will present papers on the major themes covered in the draft guidance: conceptual issues; PRO instrument selection; PRO instrument development issues; validation of PROs; and analysis, interpretation and reporting results based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 Attendees will have the opportunity to discuss and comment on these papers as well as the FDA's draft guidance.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:7/28/2017)... ... ... of the original Sharks from hit reality series Shark Tank, and the Product Managers of ... Earth. , Most people put their healthcare above their skincare, but the fact is that ... our bodies. After all, the skin is the largest organ which is why it’s imperative ...
(Date:7/28/2017)... ... July 28, 2017 , ... Join Becker's Healthcare as ... - 23, 2017 in Chicago IL. Great sessions on Epic, Cyber Security, Telehealth, Mobile ... Don't miss discussion talks by:, George W. Bush, 43rd ...
(Date:7/28/2017)... (PRWEB) , ... July 28, 2017 , ... Leyden Insurance ... families and business owners in and around Cook County, is working in conjunction with ... for students and veterans. , Established in honor of a brave soldier who is ...
(Date:7/27/2017)... NJ (PRWEB) , ... July 27, 2017 , ... ... a Diplomate of the American Board of Oral Implantology/Implant Dentistry (ABOI/ID). After successfully ... of the nation’s leading providers of dental implants . Dr. Kimowitz and ...
(Date:7/27/2017)... ... July 27, 2017 , ... For bicycling enthusiasts around ... challenge. The 24-hour race takes place against a backdrop of tree-lined hills at the ... run from July 28-30, Rad am Ring consists of some 73 curves, stretching out ...
Breaking Medicine News(10 mins):
(Date:7/11/2017)... Zymo Research Corp., also known as ,The Epigenetics Company, announced ... in a precise manner using the myDNAge ™ test. Based on ... of human genetics and biostatistics at the David Geffen School of ... Zymo Research,s proprietary DNAge ™ technology is used to analyze DNA ... ...
(Date:7/11/2017)... LINCOLNSHIRE, Ill. , July 11, 2017 /PRNewswire/ ... hematology and urinalysis diagnostic testing equipment as well ... latest innovation: a way to make quality assurance ... control processes. "Sysmex is well known for the ... SM Quality Monitor elevates quality assurance processes ...
(Date:7/10/2017)... medical equipment and supply demand is forecast to reach ... Equipment & Supplies: United States , a report ... demand for medical services – driven in large part ... gains in disposable personal income – will boost sales ... also drive sales as providers and patients seek the ...
Breaking Medicine Technology:
Cached News: