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The Cost of Change: Clinical Research is Taking Longer than Ever to Execute

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I recently wrote about the increasing complexity of clinical trials, and how, because of that complexity, sponsors are seeing an increasing number of study changes and therefore cost. But, there’s another significant effect of this complexity – clinical research is taking longer than ever to execute.

From study start-up to close-out, recent research has shown that increasing trial complexity is holding up clinical trials – with only 6% of clinical trials completed on time and 80% of trials delayed by at least one month. As an industry, we have a logical desire to collect as much data as we can to fully understand the efficacy of a new drug, its safety and all its potential applications. The number of endpoints collected has increased by 86% between 2001 and 2015. As a result, it is taking longer than ever to get new drugs to the patients that need them. So, maybe we should take another hard look at our processes to see where we can save time.

Delayed timelines start at the beginning

A recent study by the Tufts Center for the Study of Drug Development (CSDD) showed that start-up times have increased by nearly 15% over a 10-year period. Today’s clinical trials require coordination across multiple teams to achieve the varied start-up tasks across many functions, especially in global trials. For many companies, this is negatively affecting their timelines, and they are looking for ways to increase start-up efficiencies.

Study start is often delayed by long database management cycle times, including the time to build and lock study databases, as well as the need to manage disparate data sources. Protocol changes (45%), User Acceptance Testing (17%) and database design functionality (15%) represent the top three causes of database build delays.1 When these delays result in the clinical database being released after first patient/first visit (FPFV), as it does for 83% of life sciences organizations,1 key downstream data management activities, such as data entry and database lock, are delayed by up to a month. Increased timelines not only delay time to market but also increase development costs.

Integrated systems can eliminate hold-ups

The biggest difficulty appears to be dealing with changes to the clinical trial database, as evidenced by the impact of protocol changes to build time. Add to this the need to manage multiple systems, and it becomes obvious that database design should be driven by clear standards and systems as well as flexible design and an approach that ensures rapid, accurate development. Working with vendors that support flexible, rapid design and development for the most commonly used applications (EDC, 100%; RTSM, 77%; electronic master files, 70%; safety systems, 70%1) could significantly streamline study start-up.

With everything else that you have to worry about, wouldn’t it be nice to be confident that your database development isn’t holding you up? That’s why Bioclinica is guaranteeing an eight-week build for our EDC and RTSM products. Both products can easily accommodate mid-study changes and integrate with other Bioclinica and third-party systems to ensure seamless exchange of data when needed.

 

  1. Kaitin KI, editor. eClinical data volume and diversity pose increasing challenges and delays. Tufts Center for the Study of Drug Development Impact Report. 2018 Jan/Feb;20(1) 2018.

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