Oncology trials take 50% longer than other therapeutics; report

Oncology clinical trials take 50 per cent longer to go from protocol approval to randomisation of the last subject, a report found.

The figure comes from a DecisionView analysis of more than 700 studies across therapeutic areas and phases of development. Breaking apart the data by therapeutic field shows oncology clinical trials take notably longer than immunology, neurology, pulmonary, or cardiovascular studies.

Site start-up accounts for some of the difference, with oncology trials taking 25 per cent longer to complete this step, but the main bottleneck is patient recruitment. The median time taken for the 226 oncology trials to recruit was, at 79 weeks, 75 per cent longer than the time for other fields.

To shorten these timelines some are turning to emerging markets, such as the BRIC group of Brazil, Russia, India, and China. An analysis of Phase III oncology trials performed in these countries shows time savings are possible but the situation varies considerably from nation-to-nation.

Brazil and India are fastest from the initiation of the first site to randomisation of the last patient, with both countries clocking median figures of 26 weeks. This compares favourably to the median time of 57 weeks taken for all sampled Phase III trials. China lies in between the two at 41 weeks.

While companies working in BRIC countries can make gains in patient recruitment, the data suggests some of these time savings just offset delays in site start-up. Russia is the quickest at 31 weeks, but this is still twice as long as the median time across all countries, and Brazil the slowest at 55 weeks.

On Wednesday, May 16th 2012, Outsourcing-Pharma presents the second edition of the Oncology Trials Outsourcing virtual conference and expo. This year’s programme will address the role of external partnerships in achieving success in oncology trials and examine strategies for successfully recruiting patients to oncology trials. To register or find out more, go to http://goo.gl/b1mQd