Potentially life-lengthening cancer therapies could enter clinical trials and ultimately reach cancer patients dramatically faster thanks to legal contract language created by the CEO Roundtable on Cancer, a nonprofit group of cancer-fighting CEOs. The group hopes to shorten the drug testing process by making available “common language” for clinical trial contracts through a set of standardized contract templates for use by NCI-designated cancer centers and the pharmaceutical industry.
As Dr. James H. Doroshow, Director, NCI Division of Cancer Treatment and Diagnosis, stated, “It enables contract negotiators to ‘begin at the end rather than the beginning’ and reduce contract negotiation time from as many as 300 days to as few as 30 days.”
The fourteen-month project was led by the CEO Roundtable on Cancer’s Life Sciences Consortium (LSC), a task force of CEO Roundtable members in the oncology pharmaceutical/biotechnology industries in conjunction with the National Cancer Institute.
The partnership included cooperative groups and NCI-designated Cancer Centers, that were fused with a common goal to harmonize commonly used legal concepts and to propose contract provisions to be made available for use on a voluntary basis at their sole discretion. The work included seventeen legal and/or business representatives from CEO Roundtable on Cancer LSC companies and 26 representatives from NCI-designated Cancer Centers. This unique, collaborative effort was prompted in part by research demonstrating that the clinical trial contract negotiation phase included numerous opportunities to save precious time. While all parties will be free to decide whether or not to use the proposed model terms or negotiate changes to them, the project believes that they will dramatically reduce the time and expense of negotiating clinical trial agreements,
LSC, led by Dr. Gregory A. Curt, worked to craft “common language” for clinical trial contracts, noting that in the best case, the median time to open a cancer trial is 172 days. The cost of these negotiating delays is estimated to be $1 million per day – with the cost to patients being incalculable. LSC obtained copies of nearly 80 redacted clinical trial agreements from participating organizations from which key concepts were identified. They were then able to determine that final negotiated agreements showed greater than 67% convergence on the vast majority of concepts analyzed.
To further ensure that this process was transparent and voluntary, CEO Roundtable on Cancer requested an opinion from the United States Department of Justice (DOJ) that carefully reviewed both its purpose and process. The DOJ announced on September 17 that they had no objection to the workings of the LSC and its work with NCI on contract harmonization.
About the CEO Roundtable on Cancer
The CEO Roundtable on Cancer was founded in 2001, when former President George H.W. Bush challenged a group of executives to "do something bold and venturesome about cancer within your own corporate families." The CEOs responded with the CEO Cancer Gold Standard, a workplace accreditation program that calls for companies to evaluate their benefits and culture and take extensive, concrete actions in five key areas of health and wellness to fight cancer in the workplace. The CEO Roundtable on Cancer has since collaborated with the National Cancer Institute and other cancer fighting entities to find collaborative and innovative ways to eliminate cancer as a public health threat. For more information on the non-profit CEO Roundtable on Cancer and documents related to “common language” for clinical trial contracts, visit: http://www.ceoroundtableoncancer.org/.