Over the pass decade the capitalized cost to develop an approved new drug has more than doubled from $1,044M in 2003 to $2,558M in 2013 (source: CSDD, 2015), and although some have labeled this as publicized propaganda from Pharma companies as government funding has continued to increase, one fact remains indisputable that study startup in clinical trials remains highly inefficient prone to bottlenecks and errors.
Bottlenecks are something Justin, Director of Clinical Operations, is all too familiar with. Justin is responsible for selecting studies that match his local population. Since his site makes its profit by the number of subjects in a clinical trial, his focus is on patient recruitment and getting the site to IP releases as quickly as possible. “It once took a month for the CRO to answer a budget question”, said Justin. Indeed, Justin seems to spend a lot of his time ‘waiting to hear back’.
On average, Phase 2 to Phase 4 studies have 82 sites per study which average 17 months to get from protocol approval to 100% site approval. With a cost of $1,500 per month to initiate a site, it could cost $25,000 to complete all activities required to get just one site up and running. Do the math and you’ll find that study startup costs over $2 million. Reducing the time it takes to launch a study is critical to increasing the bottom line.
A recent comprehensive study undertaken by Ken Getz, Associated Professor at Tufts School of Medicine, documented numerous operating conditions that were driving these inefficiencies, the top three being; fragmentation and compartmentalization causing inconsistent decisions and practices, high aversion to risk and fear of changing legacy processes, and poor communication.
What can be done? Five suggestions for Pharma and CROs to shave time and cost from the study startup process, include; optimization of processes, collaboration with sites and study teams, improving the exchange of information, tracking of activities in real time, and using reliable analytics.
A good startup is key to the success of any clinical trial.
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