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U.S. Food and Drug Administration (FDA), is a forum for discussion and feedback regarding the soon-to-be-released FDA draft guidance for industry on using PRO measures to support medical product labeling claims. The draft guidance will be published in the Federal Register with an invitation for public comment.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Five writing teams composed of experts in PRO research will present papers on the major themes covered in the draft guidance: conceptual issues; PRO instrument selection; PRO instrument development issues; validation of PROs; and analysis, interpretation and reporting results based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 Attendees will have the opportunity to discuss and comment on these papers as well as the FDA's draft guidance.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:
(Date:7/31/2014)... Los Angeles, CA (PRWEB) July 31, 2014 ... donor wound closure in front of an enthusiastic audience ... Partial Trichophytic Closure improves the appearance of ... since the results of this procedure are minimally detectable ... this novel technique improves on the original method of ...
(Date:7/31/2014)... Washington, New York (PRWEB) July 31, 2014 ... represents whistleblowers in qui tam cases, comments that whistleblowers ... an end to illegal employer activities that may cause ... recognizes that today is National Whistleblower Appreciation Day. , ... National Whistleblower Center , the Senate declared "National Whistleblower ...
(Date:7/31/2014)... 2014 Located on one of the busiest ... Rothenberg Law Firm LLP has moved its office to the ... Rothenberg Law Firm has been handling catastrophic personal injury cases ... growth in the firm’s continued success in seeking justice for ... office has a team of experienced and successful trial attorneys ...
(Date:7/31/2014)... July 31, 2014 CarePoint Health ... Dr. Masood Rizvi, has joined our network, CarePoint ... to the community. Hundreds of highly skilled and ... comprehensive network of top doctors and practices in ... This latest acquisition represents CarePoint Health’s commitment to ...
(Date:7/31/2014)... To further educate the public, The Rothenberg Law ... information regarding leaving children in hot vehicles: , Leaving ... Because a child’s body can heat up three to ... alone in a hot vehicle puts them at extreme ... of Children Left Alone in a Car , According ...
Breaking Medicine News(10 mins):Health News:Novel Technique in Wound Closure Delivers More Discreet Results in Hair Transplant Patients 2Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 2Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 3Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 4Health News:Dr. Rizvi Joins CarePoint Health Medical Group 2Health News:The Rothenberg Law Firm LLP Teams Up with Local Philadelphia TV Stations to Promote Awareness of the Dangers of Leaving Children Unattended in a Hot Vehicle 2Health News:The Rothenberg Law Firm LLP Teams Up with Local Philadelphia TV Stations to Promote Awareness of the Dangers of Leaving Children Unattended in a Hot Vehicle 3
(Date:7/31/2014)... SAN DIEGO , July 31, 2014  Sorrento Therapeutics, ... death of Mr. Amar Singh , Chief Business Officer ... of apparent natural causes on July 30. "Sorrento ... dear friend and colleague. Our immediate thoughts go to Amar,s ... President and Chief Executive Officer. Mr. Singh ...
(Date:7/31/2014)... -- STAAR Surgical Company (NASDAQ: STAA ) ... and delivery systems for the eye today reported revenue ... $20.0 million, a 10% increase over $18.2 million reported ... currency basis, revenues grew 11% during the second quarter ... The effect of foreign currency exchange reduced sales by ...
(Date:7/31/2014)... VIEW, Calif., July 31, 2014 IRIDEX Corporation (Nasdaq: ... second quarter and six months ended June 28, 2014.  ... of 2014, up 15% from $9.2 million in the 2013 ... first quarter of 2014. Revenues for the first six months ... in the first six months of last year. , ...
Breaking Medicine Technology:Sorrento Announces the Unexpected Death of its Chief Business Officer 2STAAR Surgical Reports 10% Second Quarter Revenue Growth 2STAAR Surgical Reports 10% Second Quarter Revenue Growth 3STAAR Surgical Reports 10% Second Quarter Revenue Growth 4STAAR Surgical Reports 10% Second Quarter Revenue Growth 5STAAR Surgical Reports 10% Second Quarter Revenue Growth 6STAAR Surgical Reports 10% Second Quarter Revenue Growth 7STAAR Surgical Reports 10% Second Quarter Revenue Growth 8STAAR Surgical Reports 10% Second Quarter Revenue Growth 9STAAR Surgical Reports 10% Second Quarter Revenue Growth 10STAAR Surgical Reports 10% Second Quarter Revenue Growth 11STAAR Surgical Reports 10% Second Quarter Revenue Growth 12STAAR Surgical Reports 10% Second Quarter Revenue Growth 13STAAR Surgical Reports 10% Second Quarter Revenue Growth 14STAAR Surgical Reports 10% Second Quarter Revenue Growth 15STAAR Surgical Reports 10% Second Quarter Revenue Growth 16STAAR Surgical Reports 10% Second Quarter Revenue Growth 17STAAR Surgical Reports 10% Second Quarter Revenue Growth 18STAAR Surgical Reports 10% Second Quarter Revenue Growth 19STAAR Surgical Reports 10% Second Quarter Revenue Growth 20STAAR Surgical Reports 10% Second Quarter Revenue Growth 21STAAR Surgical Reports 10% Second Quarter Revenue Growth 22STAAR Surgical Reports 10% Second Quarter Revenue Growth 23STAAR Surgical Reports 10% Second Quarter Revenue Growth 24STAAR Surgical Reports 10% Second Quarter Revenue Growth 25STAAR Surgical Reports 10% Second Quarter Revenue Growth 26STAAR Surgical Reports 10% Second Quarter Revenue Growth 27STAAR Surgical Reports 10% Second Quarter Revenue Growth 28STAAR Surgical Reports 10% Second Quarter Revenue Growth 29STAAR Surgical Reports 10% Second Quarter Revenue Growth 30STAAR Surgical Reports 10% Second Quarter Revenue Growth 31IRIDEX Reports 2014 Second Quarter, Six-Month Results 2IRIDEX Reports 2014 Second Quarter, Six-Month Results 3IRIDEX Reports 2014 Second Quarter, Six-Month Results 4IRIDEX Reports 2014 Second Quarter, Six-Month Results 5
Cached News: