The Nation's Investment in Cancer Research

Common Language for Clinical Trial Contracts

Clearly, the future of personalized oncology will require the use of multiple, targeted therapies in order to block the many pathways that cancer cells exploit to grow and spread throughout the body. Testing combinations of such therapies in human clinical trials, however, has proven to be a daunting task. Such trials often involve collaboration between several companies, each of which has intellectual property concerns. Dealing with such issues and hammering out contract details often leads to long delays, if not complete derailment, of clinical trials.

NCI’s leadership, as a broker between the public and private sectors, is helping break the logjam of lengthy and costly contract negotiations for partnerships between the pharmaceutical industry and academic research institutions, including NCI-designated Cancer Centers. This came about through NCI’s participation in the CEO Roundtable on Cancer, a unique group of corporate CEOs, academic research presidents, and other leaders from 42 organizations.

“NCI’s involvement with the CEO Roundtable since its inception in 2001 has been critical,” commented the group’s chief operating officer, Martin J. Murphy, Jr., Ph.D. “We pledged to shorten the time for industry-academic partnership negotiations from as much as 300 days down to 30 days…but it couldn’t have happened until NCI got involved.”

Dr. Murphy credits NCI’s leadership for recommending that the CEO Roundtable establish a Life Sciences Consortium (LSC) made up of Roundtable members from the pharmaceutical, biotechnology, and academic research communities. The goal of the LSC is to “look into the pre-competitive space where there are problems common to all members of the Consortium,” Dr. Murphy said.

The first major impediment the LSC addressed is the length of time it takes to negotiate a clinical research agreement between a pharmaceutical company, which has a drug to be tested, and an academic institution such as an NCI-designated Cancer Center. “It currently takes anywhere from 180 to 300 days,” Dr. Murphy noted, costing companies more than $1 million a day in delays. The CEO Roundtable identified this as a priority issue four years ago, he recalled, but progress stalled until NCI leaders stepped forward in 2007, “that was the key that opened the door.”

With financial support from NCI and the CEO Roundtable, the LSC analyzed 84 clinical contracts. They created an online Master Agreement template of “harmonized” contract language “that will eliminate literally hundreds of days of back and forth negotiations,” Dr. Murphy added. The Master Agreement is free for everybody to use, and is posted on Cancer.gov at http://cancercenters.cancer.gov.

On Sept. 17, 2008, The Department of Justice announced that it would “not oppose” the model contract language, which “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.”

NCI, along with the LSC, will now move on to tackle issues of intellectual property rights that often impede public-private sector collaborations. “I applaud NCI’s leaders for doing what they do best — which is not only pioneering research but also in pointing the way for research to prosper in the future,” Dr. Murphy said.