Quintiles Takes Action to Speed Development of Cancer Therapies
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The adoption of the common contract language has the potential to significantly reduce contract negotiation time, which currently takes a median of 172 days (nearly 6 months) and as much as a year.
“Data clearly demonstrate that the time it takes to get to a final clinical trial agreement is rate-limiting and often the cause of significant delays in the development of experimental drugs,” said Oren Cohen, M.D., Quintiles’ Chief Medical and Scientific Officer and member of the CEO Roundtable Life Sciences Consortium (LSC). “We are hopeful that streamlining the process to begin a cancer trial will shorten the time it takes to get critically-needed therapies to the patients who need them.”
Quintiles, the only contract research organization (CRO) represented, was a significant contributor to the 14-month project which was led by the CEO Roundtable on Cancer’s LSC, a task force of CEO Roundtable members in the oncology pharmaceutical/biotechnology industries in conjunction with the National Cancer Institute.
The group hopes to shorten the drug testing process by making available “common language” for clinical trial contracts through a set of standardized contract clauses for use by NCI-designated cancer centers and the pharmaceutical industry. Click here for more information on the complete report and related documents.
The work included 17 legal and/or business representatives from CEO Roundtable on Cancer LSC companies and 26 representatives from NCI-designated Cancer Centers. This collaborative effort was prompted in part by research demonstrating that the clinical trial contract negotiation phase included numerous opportunities to save precious time.
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.