Navigation Links
Assessing positive outcomes of phase III trials
Date:12/3/2010

Randomized phase III studies should be designed to find out whether a new drug or treatment makes a meaningful difference in patients' survival or quality of life, according to a commentary published online December 3rd in The Journal of the National Cancer Institute. Instead, most trials now are designed to detect a statistically significant difference between treatment and control groups, which may not be clinically meaningful, write Alberto Ocana, M.D., Ph.D. and Ian F. Tannock, M.D., Ph.D., of Princess Margaret Hospital in Toronto.

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) approve drugs usually based on statistically significant results of randomized phase III trials comparing a new, investigational drug with standard treatment. Ocana and Tannock note that pharmaceutical companies have typically sponsored clinical trials that are large enough to detect statistically significant differences in survival. But these differences are often trivial, they say. For instance, the trial that led to approval of erlotinib (Tarceva) for pancreatic cancer found that patients who took the drug had a median survival just 10 days longer than patients in the control group. However, the difference was statistically significant, and the drug was approved.

The authors write that pharmaceutical companies look for a difference in survival outcome between two groups of a trial that is "not usually the minimal difference in overall survival or progression-free survival that is clinically important, but more likely the minimal difference that is feasible to detect, considering the limits on the sample size and hence the cost of the trial."

The authors argue for another approach: "Ideally, trials should be designed [to detect] the minimum clinically important difference, taking into account the tolerability and toxicity of the new treatment, that would persuade oncologists to adop
'/>"/>

Contact: Kristine Crane
jncimedia@oxfordjournals.org
301-841-1285
Journal of the National Cancer Institute
Source:Eurekalert

Page: 1 2

Related medicine news :

1. Researchers validate a new test for assessing childrens and teenagers fitness to prevent morbidity
2. Assessing the science behind health claims
3. For HIV-positive patients, delayed treatment a costly decision
4. Positive Attitude, Planning May Help Women Through Menopause
5. Positive psychological changes from meditation training linked to cellular health
6. Positive social traits trump bad health habits
7. Targeted therapy promising for HER2-positive metastatic breast cancer
8. New study finds positive return on investment for states that invest in quit smoking treatments
9. Study shows tranquil scenes have positive impact on brain
10. Survey of American women finds STD vaccine viewed positively
11. Penns Positive Psychology Center awards $2.9 million for research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... ... August 28, 2015 , ... Joining a ... Memorial Hospital recently transitioned management companies to partner with Wound Care Advantage (WCA) ... outpatient wound center. , Transitioning wound care management providers can be a ...
(Date:8/28/2015)... ... , ... With the goal of furthering music education programs in schools, the ... County Fairgrounds in Mendon, IL on May 30th, 2015. Backed once again by Best ... the underfunded school districts of Mendon and its neighboring town of Quincy, IL. Best ...
(Date:8/28/2015)... Michigan (PRWEB) , ... August 28, 2015 , ... On ... Western Michigan, joined as sponsor of the “Music With A Mission” benefit concert in ... behind the event was to raise money to support music education programs in the ...
(Date:8/28/2015)... ... 28, 2015 , ... Drugs and alcohol abuse by employees ... new approach on solutions in his new book ":Unraveling The Psychological Mystery of ... together for meaningful group meetings. "This would educate the employees on not ...
(Date:8/28/2015)... ... August 28, 2015 , ... ... loyalty at a low cost. Personalized with practice contact information and logos, Calendars ... Dental offices can also incorporate Calendars into seasonal mailings, thank you and welcome ...
Breaking Medicine News(10 mins):Health News:Decatur County Memorial Hospital Transitions Wound Center Management To Wound Care Advantage and the Luvo Operating System 2Health News:Decatur County Memorial Hospital Transitions Wound Center Management To Wound Care Advantage and the Luvo Operating System 3Health News:Decatur County Memorial Hospital Transitions Wound Center Management To Wound Care Advantage and the Luvo Operating System 4Health News:Best Drug Rehabilitation Interviews Country-Rock Duo Highway Run at the 2015 "Music With A Mission" Benefit Concert 2Health News:New Video Released on "Music With A Mission" Benefit Concert Headlining Artist Cadillac Three & Best Drug Rehabilitation 2Health News:SmartPractice® Introduces 2016 Calendars for Dental Practice Giveaways 2
... ... to showcase her work at the 32nd annual Artexpo New York. Renea’s sculpted ... movement of the imagination in a textured oasis. Art enthusiasts say her use ... real a vivid, truly amazing work. Each of the swirls she creates ...
... ... ... , ... , , , , ...
... New ... men, as well as infertility diagnosis, treatment and options. , ... (PRWEB) March 9, 2010 -- A new Australian website ( ... attempts at conceiving aren,t successful within the first few months. , , ,The reality is ...
... ... ... ... , , ...
... ... ... ... ...
... ... ... , ... , , ...
Cached Medicine News:Health News:Red Hot Artist Renea Menzies Has Flower Power; Houston, Texas Artist Renea Menzies Showcases Her Work in NY 2Health News:Red Hot Artist Renea Menzies Has Flower Power; Houston, Texas Artist Renea Menzies Showcases Her Work in NY 3Health News:Justice Department Files for Immediate Relief Regarding Conditions at Conway Human Development Center, in Conway, Arkansas 2Health News:Justice Department Files for Immediate Relief Regarding Conditions at Conway Human Development Center, in Conway, Arkansas 3Health News:Justice Department Files for Immediate Relief Regarding Conditions at Conway Human Development Center, in Conway, Arkansas 4Health News:'Get Pregnant' Aims To Help Couples Conceive Naturally, Faster 2Health News:MedCAREERS GROUP, Inc. Assumes Operating Control of WorkAbroad.com 2Health News:MedCAREERS GROUP, Inc. Assumes Operating Control of WorkAbroad.com 3Health News:MedCAREERS GROUP, Inc. Assumes Operating Control of WorkAbroad.com 4Health News:MedCAREERS GROUP, Inc. Assumes Operating Control of WorkAbroad.com 5Health News:IntraHealth International Opens Washington, D.C. Office 2Health News:IntraHealth International Opens Washington, D.C. Office 3Health News:IntraHealth International Opens Washington, D.C. Office 4Health News:IntraHealth International Opens Washington, D.C. Office 5Health News:South Dakota Students with Asthma Can Breathe Easier After New Law Allows Self-Administered Medications 2
(Date:8/28/2015)... Aug. 28, 2015 Research ... of the "Investigation Report on China,s Tobramycin Market, ... is a traditional antibiotic whose eye drop and ointment ... of potential infection or inflammation caused by eye infection. ... are able to produce tobramycin, among which the ...
(Date:8/28/2015)... Research and Markets ... the "Investigation Report on China,s Quetiapine Market, ... Developed by AstraZeneca plc, quetiapine (under the trade ... the treatment of schizophrenia. Approved by CFDA to ... the Catalogue of Drugs for the Basic National ...
(Date:8/28/2015)... 28, 2015 Research and ... the "Investigation Report on China,s Ranibizumab Market, 2012-2019" ... Novartis, ranibizumab was approved by CFDA to treat wet ... Lucentis, a product of Novartis, is available in the ... self- developed drug for the treatment of wet AMD ...
Breaking Medicine Technology:Investigation Report on China's Tobramycin Market, 2015-2019 2China Quetiapine Market Investigation Report 2010-2019 2Investigation Report on China's Ranibizumab Market, 2012-2019 2
... Compact high speed refrigerated floor-standing centrifuge. ... popular protocols of classical 3 liter ... programmed radius including for adaptors, informative ... acceleration & 10 braking rates (100 ...
... The Rotanta 460 ... an extraordinary line that ... of demands. They feature ... performance. Their state-of-the-art technology ...
... Spinchron 15 centrifuge provides all ... needed for today's full-service clinical ... has a speed up to ... to spin tubes, plates and ...
... an uniquely designed direct reading ... which tubes are filled, transported ... carrying tray. Spin cycle of ... operation, automatic electric brake, high ...
Medicine Products: