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Accelerating Study Start-up

Ashley Davidson, Director of Vault Study Startup, shares study start-up industry trends and drivers for improvement from the 2019 Veeva Unified Clinical Operations Survey.

To learn more, download the complete survey report.

Video Transcript

There’s still quite a bit of opportunity and running room with which to transform study start-up, so quite a bit of work to be done throughout the industry. What we’ve been seeing is within the last 15 years throughout the industry across large pharma organizations and small ones alike. We’ve seen the average time it takes to identify and then activate sites hover right around seven to eight months globally. In the last two years, however, that cycle time has been gradually worsening by about four to six weeks on average. The largest factors contributing to those delays being the site feasibility and survey completion process, which accounts for anywhere from about a quarter to a third of that cycle time. And it also now takes twice as long to negotiate contracts with trial sites. Certainly protocols are more complex than ever before, in general, it’s just more challenging to manage trials today and study start-up in particular is more complex than it ever has been before.

But I think it’s also worth noting the role technology has played in start-up historically over this 10 to 15-year period. Historically purpose-built start-up technologies have been relatively nascent, even non-existent in some cases, and so a large part of the industry is still lumbering along managing very complex start-up activities across complex trials with extremely manual and transactional approaches, still largely email and Microsoft Excel spreadsheets. We also see cases of organizations taking existing systems, perhaps a CTMS system or a SharePoint system, and inserting as much of the start-up process as they can into those types of tools. But the reality is that these tools are not purpose-built for all the challenges the start-up presents. And so this approach still leaves a lot of process and visibility gaps, the duct tape to fill those gaps, then yet again becoming spreadsheets. We’ve also seen an emergence in the last couple of years in separate independent technologies that have been stitched together into platforms via integrations, which from an end-to-end process and data visibility standpoint, again, remains cumbersome and really perpetuates the disjointed nature of start-up in the first place.

The data from the unified clinical survey also seems to support these observations with respect to start-up challenges and really how the industry is approaching those challenges. According to the survey, most trials, about 86%, experienced delays in meeting start-up time lines and those delays are costing sponsors on average up to $2 million dollars per month. The research from Tufts Center for the Study of Drug Development shows that cycle times can significantly be delayed due to largely paper-based processes and a lot of different manual handoffs throughout the start-up process from beginning to end. And consistent with these findings, about 100%, so all of the survey respondents of the unified clinical survey, report challenges of some kind with their start-up process. So let’s take a look in more detail as to what some of those challenges are. As mentioned, site contracting and budgeting still accounts for most of the cycle time, roughly three-quarters of sponsors and CROs, about 73%, say that site contract and budgeting are still their most challenging study start-up processes today.

And this result is actually up 20 percentage points since last year’s survey. Today’s sponsors are trying to do a lot with a lot less because of the specialization in medicine. There are fewer sites becoming qualified for some of these specialized indications. And so the funnel of sites with which to work is much smaller. Sites are in more demand trial after trial. And so what we’re seeing is a larger backlog in terms of contracting activities. From a technology perspective, we see a pretty siloed process still whereby the tools being utilized to negotiate site contracts are very manual and are typically not connected to some of the other broader contract management systems being used throughout the rest of the organization, or to other clinical operations tools as well for things like vendor contracts and other processes, perhaps further perpetuating some of the delays in this particular area. About half of survey respondents, 49%, say that site identification and selection is a top challenge and limits their ability to speed their trials. And this is followed by IRB and ethics committee approval and planning delays at 42%. These are both areas where more predictive planning, better performance data could really move the needle forward towards a more streamlined automated process.

Now the survey also supports the observation that the industry is still largely utilizing very manual transactional and disconnected approaches in start-up. Most respondents, about 81% of you, still use spreadsheets really as a large majority of the industry to manage study start-up activities. Roughly 1/3 or less actually are using CTMS applications. And as you can see other tools are also still being used as well, such as eTMF’s, homegrown applications, independent online survey tools at 35, 29, and 25% respectively. Significantly more CROs than sponsors are utilizing newer purpose-built study start-up applications. 28% of CROs using start-up applications versus just 12% of sponsors respectively, and this is likely due in part to the increase in outsourcing of study start-up activities to CROs. Now the good news is that the industry as a whole is focused on improving study start-up. For most respondents, faster study startup times, 71% of you, said that was one of the key drivers of focusing on ways that you can improve study start-up.

Streamline site contracting and budgeting as well and also as mentioned site feasibility and selection outcomes and improving those are the top drivers for making some of those improvements. We know from survey respondents in the 2018 Veeva Unified clinical survey that improving start-up was a major priority focus area across many of the organizations throughout the industry. So much so, that they either already had an improvement initiative in place, or going to have one in place within the next year or two. As such, we anticipate the percentage of organizations that will move to purpose-built start-up technologies versus spreadsheets and other manual methods to continue to steadily increase within the next one to two years as Jim mentioned as well at the beginning. Additionally, about half of respondents say easier collaboration between sponsors, CROs, and sites is essential for improving start-up specifically.

And as Jason highlighted earlier the importance of collaboration and driving greater speed and efficiency. And some, with respect to study start-up, delays in the study start-up phase create a cascading effect when critical path milestones and start-up activities are missed upfront. And this ultimately results in significant trial delays, but more importantly, increased cost. Research has shown that as many as 70% of studies run more than 1 month behind schedule and the cost impact of those delays can for sponsors land anywhere between $600,000 and $8 million dollars for each day that a trial is delayed. Also the cost of initiating a site has been estimated at $20-30,000. So with as many as 11% of sites failing on a single study to enroll a single patient, poor site selection is estimated to increase the cost of clinical trials itself by at least 20%. So as you can see, study start-up continues to be a critical area of trial management that we’re all talking about with a lot of room for efficiencies and improvements.