US contract research organisation PRA International has signed an exclusive licensing agreement that should give it a better handle on patient recruitment for oncology trials, an area with huge discrepancies between supply and demand.

The agreement is with IntrinsiQ Research, for use of the Intellidose electronic medical record software used by IntrinsiQ to track oncology patients in the US. Each month the company collects real-time longitudinal data from over 600 oncology physicians on more than 45,000 patient treatments for most types of cancer. The value of this information to PRA is that it can forecast more accurately patient recruitment for oncology studies. That in turn should make for a speedier and more efficient trial programme.

“The most critical issue today in oncology drug development is the ability to determine the available patient population for any specific tumour type,” commented Kent Thoelke, PRA’s senior vice-president, Therapeutic Expertise. The company has already been trialling the IntrinsiQ data with a number of its clients, exceeding their expectations on timelines and budgets for patient recruitment, it noted.

The data include detailed information on demographics, tumour type, disease stage, previous treatment, current anticancer regimens, concomitant medication, laboratory measurements, scans, responses, time to progression and other key criteria. According to IntrinsiQ, they are “the established industry benchmark, in use by 90% of the pharmaceutical companies in the US, as well as industry analysts”. The agreement with PRA, it added, “allows us to extend our leadership position into the contract research space”.

Oncology Research deal

The arrangement also further raises PRA’s standing in oncology clinical development following the agreement it signed in January with US Oncology Research, one of the country’s largest cancer research networks. That tie-up was also expected to help PRA forecast more accurately the eligible populations and timeframes for oncology trials, by leveraging US Oncology’s historical working relationships with research sites to produce more detailed feasibility studies.

The difficulty of recruiting cancer patients for clinical trials in the US was highlighted starkly last year in a study conducted by researchers at the Geriatric Oncology Consortium in Baltimore. With fewer than 5% of oncology patients actually participating in oncology trials, at a time when the number of anticancer compounds in development has increased dramatically, it found that for breast cancer nearly 60% of all newly diagnosed patients would have to enrol in studies to meet demand.

John Lewis, director of marketing and public relations for PRA International, does not expect to see a reversal of this trend, even with more efficient recruitment strategies. The prospect of conducting an exclusively US trial for an oncology product is no longer realistic, he told PharmaTimes World News. To ensure adequate numbers of patients, companies have to look further afield, to Latin America, Eastern Europe, Asia or India.