We can all attest to the fact that clinical research is becoming increasingly complex. We’re expected to manage constantly evolving regulatory requirements, greater numbers of sites (and patients) per study, institutional/vendor/sponsor relationships, and an industry-wide shift to a patient-centric approach. It is becoming nearly impossible to anticipate every detail, and change orders are all but inevitable.
A review of oncology trials from 1996 to 2016 showed that in 2016 the median number of procedures, tests, assessments, and pharmacokinetic requirements was significantly higher than in 1996. Another report found that from 2001-2005 to 2011-2015, the total number of study endpoints increased 86%. In those years, drug makers in Phase III trials also doubled the number of countries and increased the number of investigative sites in their trials by 63%.
Because of these factors as well as patient recruitment difficulties, the cost of studies is increasing. According to a 2014 study by the Tufts Center for the Study of Drug Development, it costs about US $2.6 billion to bring a drug to market in the US. In fact, a 2018 study in JAMA Internal Medicine listed an example of a US $2.1 million trial…that had only four patients enrolled!
Study changes are a significant driver of cost – including protocol amendments, study extensions, and additional external integrations. According to the same 2014 Tufts study, 60% of all trial protocols have at least one major global amendment, with a median cost per amendment of $141,000. Based on our own experience at Bioclinica, change orders result in a 25% increase in trial cost for the average study. And, this cost is associated with fewer than 100 hours in change orders, as occurs for more than half of our studies.
While expensive, protocol changes related to new discoveries or patient safety are a little easier to swallow. But, what about those changes that are just the result of oversight or a rushed build – when you need to add a new question to a form or a new field to your database? Imagine if you didn’t have to worry about the costs related to those changes. Your team could better focus on the important study tasks, and those funds could be used for future studies.
That’s why we’re introducing no charge for change orders on our EDC and RTSM products through the end of Q1 for new clients. After all, sponsors should remain focused on trial execution, not change orders.