The non-profit group, made up of the CEOs of drugmakers working in oncology, hopes to shorten the drug testing process by making available "common language" for clinical trial contracts through a set of standardized templates
Dr. James Doroshow, Director of the US national Cancer Institute’s Division of Cancer Treatment and Diagnosis, said that the templates could allow contract negotiators to “begin at the end rather than the beginning.”
That could reduce contract negotiation time from as many as 300 days to as few as 30 days.
That could be a huge time and resource-saving exercise for the pharmaceutical industry. It is estimated that the number of clinical studies for oncology drugs rose by 13 per cent last year - amounting to nearly 15 per cent of the total number of clinical trials that were started.
The templates are the culmination of a 14-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 NCI.
The effort was prompted in part by research demonstrating that the clinical trial contract negotiation phase included numerous opportunities to save time.
LSC’s Dr. Gregory Curt said that the median time to open a cancer trial is 172 days. The cost of these negotiating delays is estimated to be $1m per day - with the cost to patients being "incalculable," according to the CEO Roundtable.
As part of the exercise LSC obtained copies of nearly 80 redacted clinical trial agreements from participating organisations from which key concepts were identified. They found that final negotiated agreements showed greater than 67 per cent convergence on the vast majority of concepts analysed.
The US Department of Justice (DOJ) has reviewed the proposals and concluded it has no objection to the workings of the LSC and its work with NCI on contract harmonization.