The U.S. Department of Justice (DoJ) has cleared the way for NCI and the CEO Roundtable on Cancer to move ahead with an effort to speed clinical trial contract negotiations by issuing a "business review letter" about the high-priority project.

The communication from the DoJ's Antitrust Division was requested by the CEO Roundtable to ensure there were no antitrust concerns related to the organization's ongoing efforts with NCI to develop "model language" for use in the contract agreements that govern clinical trials.

"The Department has no present intention of challenging the proposal to develop and publicize model clauses for use in clinical trial agreements," Assistant Attorney General Thomas O. Barnett explained in the letter.

"Although there is still work to be done, the DoJ's response ensures we can continue forward with this effort to streamline the negotiation process and expedite the performance of clinical trials," said NCI Director Dr. John E. Niederhuber. "This entire effort is another example of NCI's ability to be an honest broker, bringing the necessary parties together to facilitate the collaboration and partnerships needed to tackle some of the most profound challenges in conducting clinical trials."

NCI at APHA Be sure to visit the NCI exhibit booth during the American Public Health Association (APHA) Annual Meeting October 26-29 in San Diego, CA. The NCI exhibit will be located in booth #1101.

These clinical trial negotiations typically include the companies whose agents or medical devices are being used in the trial, the academic medical centers where the trials are to be conducted, and the principal investigators who lead the trials. Due to their complex nature, negotiations can take months to conduct and cost the companies involved up to $1 million a day.

Developing model language for clinical trials contracts was identified as a top priority by NCI's Clinical Trials Working Group in its 2005 report, and by private sector participants in the Roundtable's Life Sciences Consortium, which includes some of the country's largest pharmaceutical and medical device companies.

Representatives from the Life Sciences Consortium and a number of NCI-designated Cancer Centers and Cooperative Groups have participated in the model language effort. The process involved a review of 78 clinical trials agreements, some of which were contract templates, but most of which were redacted copies of actual contracts. From that review, stipulations or clauses in seven key areas (see sidebar) were found that routinely bogged down negotiations. Even so, nearly two-thirds of the time the final contract language in those areas was essentially identical.

"Anything that can codify potential contract language and speed the negotiations is of significant value," said Dr. Shelley Earp, director of the Lineberger Comprehensive Cancer Center at the University of North Carolina, who has been involved in the model language initiative. "There are always going to be specifics from trial to trial that differ, but if we can start with these generic endpoints, hopefully we can save a lot of time."

Dr. James Doroshow, director of NCI's Division of Cancer Treatment and Diagnosis, estimates that it could cut negotiation times by up to 3 months. "In some cases, that sort of time savings can make or break a trial," says Dr. Earp. "The longer you delay the launch of a trial, the more likely it is to fail," he says.

Clearing the Smoke The model language that has been developed for use in clinical trial contract negotiations covers seven areas in which negotiations regularly stall. They include: Intellectual property Study data Indemnification Subject injury Confidentiality Publication rights Biological samples (still under development)

And even when a trial does eventually get off of the ground, explains Dr. David Dilts - who, along with colleagues at Vanderbilt University, has conducted several important time management studies on the cancer clinical trials system - the delays caused by long negotiations can be costly.

"Our research demonstrates that the length of time required to open a trial has a dramatic negative impact on eventual accrual to the study," Dr. Dilts says. "So these templates will not only affect the ability to launch trials, but also their eventual success."

The response thus far, according to Dr. Doroshow, has been very encouraging.

"I have had input from several companies that are very interested in starting to use this language," he says. "However, only time will tell how heavily it will actually be used."

The next steps, says Dr. Sheila Prindiville, director of NCI's Coordinating Center for Clinical Trials and one of the leaders of this effort, will be to gather more input from all of the NCI-designated Cancer Centers, Cooperative Groups, and their affiliated universities. The updated language and further information on this project will be posted publicly on NCI's Cancer Centers Web site.

—Carmen Phillips