subject: Oncology Trials Take 50% More Time To Complete Than In Other Areas [print this page] The quarterly DecisionView analysis of the drug development industry has concluded that oncology trials take 50% longer to get to the last subject than any other therapeutic.1
DecisionView conducted the study using 700 trials across various development stages and therapeutic areas. When they ordered the data by therapeutic area, it soon became clear that oncology trials took far longer than those of neurology, cardiovascular, and immunology studies.
Contributing factors
It was partially the start-up time that accounted for the difference with oncology taking 25 per cent longer than any other area. However, the main issue was patient enrolment. Of the 226 oncology trials that were examined, the median enrolment completion time was 79 weeks, 75 per cent more than any other therapeutic.2
This comes as worrying news for pharmaceutical companies looking to conduct oncology trials. Compounded delays caused by patient recruitment are the last thing a drug development firm needs in light of the fact that each day lost in getting a compound to market can cost 5 million.
Possible solutions
Whether anything can be done to reduce the completion time of oncology trials in particular remains to be seen but there are a number of possible measures to reduce any trial timeframe open to pharmaceutical companies.
Drug developments firms are increasingly looking to contract research organisations (CROs) to make use of their unique access to patient populations in emerging markets. The so called BRIC countries (Brazil, Russia, India, and China) have burgeoning patient populations that have faster enrolment times than the UK. CROs such as PSI claim that 90% of their patient enrolment is completed ahead of schedule due to their ability to harness the huge enrolment potential of emerging markets.
The DecisionView study found that, across Phase III oncology trials, patient enrolment in Brazil and India was completed within a median of 26 weeks. However, pharmaceutical companies looking to form a partnership with a CRO should be aware that in some instances, the reduced timeframes in patient enrolment just offset delays in site start-up. Russia has a median of 31 weeks, the quickest of all BRIC countries, but this is double the median across all countries involved in the study.
The sponsor should ensure that they partner with a CRO that has a verifiable record of successful trials and an industry-wide reputation for therapeutic excellence, not just attractive enrolment timeframes.
