Navigation Links
Justice Department Will Not Oppose CEO Roundtable on Cancer's Proposal
Date:9/17/2008

WASHINGTON, Sept. 17 /PRNewswire-USNewswire/ -- The Department of Justice announced today that it will not oppose a proposal by the CEO Roundtable on Cancer (CRC) to develop and publicize model contract language for clinical trials of potential new cancer treatments. The Department said the language is not likely to be anticompetitive and can be used to help increase efficiency in contract negotiations, potentially reducing costs and shortening the time needed to begin clinical trials.

The Department's position was stated in a business review letter from Thomas O. Barnett, Assistant Attorney General for the Antitrust Division, to counsel for the CRC.

The CRC and the National Cancer Institute (NCI) will jointly lead the project to develop model language for clinical trials. The CRC is a non-profit organization whose goal is to make continuous progress toward the elimination of cancer as a personal disease and public-health problem. The NCI is the federal government's principal agency for cancer research and training and is part of the U.S. National Institutes of Health.

The CRC requested a business review letter from the Division expressing its enforcement intentions regarding the CRC's and NCI's proposal to develop and publicize model clauses for use in clinical-trial agreements. Clinical-trial agreements typically involve three parties: a pharmaceutical or medical-device company known as a "sponsor"; a hospital, clinic, or university where the research is performed, known as the "research institution"; and the physician who is in charge of the trial, known as the "principal investigator."

"Making the model language available to sponsors, research institutions, and principal investigators, as proposed by CRC, is not likely to reduce competition," Barnett said in the letter. In the letter, Barnett explained that the "model language does not contain any provisions specifying prices or rates," and that "[w]hether to use the language or any of its provisions will be left to the determination of each party acting independently."

Under the Department's business review procedure, an organization may submit a proposed action to the Antitrust Division and receive a statement as to whether the Division currently intends to challenge the action under the antitrust laws.

A file containing the business review request and the Department's response may be examined in the Antitrust Documents Group of the Antitrust Division, U.S. Department of Justice, 450 Fifth Street, NW, Suite 1010, Washington, D.C. 20530. After a 30-day waiting period, the documents supporting the business review will be added to the file, unless a basis for their exclusion for reasons of confidentiality has been established under the Business Review Procedure.


'/>"/>
SOURCE U.S. Department of Justice
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Baxter Awarded Pandemic Advanced Supply Contract from the Department of Health
2. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Chester County Dairy
3. U.S. Department of Health and Human Services Completes Funding of 2006 Contract Award to CSCs DVC and Baxter
4. DuPont Provides Technology for Washington Hospital Centers Emergency Department
5. NYC Department of Healths Get Some NYC Condoms Sends Wrong Message and Misuses Tax Dollars, says MIM President Bob Peters
6. PA Department of Health Reports Rise in Flu Activity; Reminds Public of Need for Flu Shot
7. Columbia University Medical Center and Rosetta Genomics Announce Columbia Universitys Submission of the First Cancer Diagnostic Test Based on Rosetta Genomics Proprietary MicroRNA Technology for Approval to the New York State Department of Health Clinica
8. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Lebanon County Dairy
9. Pediatric Heart Transplants at Montefiore Approved by NY State Department of Health
10. Deloitte and Nonprofit Roundtable Host Real-World Disaster Exercise as Next Step in Developing Preparedness Plan for Greater Washington Region
11. Jennerex Presents Clinical Data From JX-594 Demonstrating Tumor Efficacy Against Advanced Liver Cancers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/27/2017)... MIAMI , Sept. 27, 2017  Commended for their ... recent notable awards. Ranked as number one in the South ... ninth time in Inc. 5000 yearly list, the national specialty ... CEO, Armando Bardisa will soon be honored by ... Set to receive his award ...
(Date:9/25/2017)... , Sept. 25, 2017   Montrium , ... File solutions, today—from the IQPC Trial Master Files ... , NL)—announced that EastHORN Clinical Services has selected ... programs and TMF management. EastHORN, a leading European ... platform to increase transparency to enable greater collaboration ...
(Date:9/23/2017)... 22, 2017 Janssen Biotech, Inc. (Janssen) announced ... from the U.S. Food and Drug Administration (FDA) for ... for the treatment of moderately to severely active rheumatoid ... data are needed to further evaluate the safety of ... RA. "We ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes ... a mock evacuation of the facility as part of a disaster drill on October ... Hose EMS and Shelton City Emergency Manager, as well as the Connecticut Long ...
(Date:10/13/2017)... NY (PRWEB) , ... October 13, 2017 , ... Ellevate ... people in business to advocate for action towards gender equality at their inaugural Summit ... from around the globe, and reached a social audience of over 3 million. To ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... viewers the lowdown on sciatica in a new episode of "Success Files," which ... current events and innovation and investigates each subject in-depth with passion and integrity. ...
(Date:10/13/2017)... ... , ... “America On The Brink”: the Christian history of the United States ... creation of published author, William Nowers. Captain Nowers and his wife, Millie, have ... thirty years in the Navy. Following his career as a naval aviator and ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
Breaking Medicine News(10 mins):