Getting a clinical trial off the ground is one of the most time-consuming aspects of the drug development process. According to Veeva Systems, study start-up can take up as much as 61% of the total trial cycle time.
With Veeva 2020 Study Start-up Pulse Report & Assessing Post-COVID Readiness, the company seeks to answer some of the tough questions about how sites and sponsors have been handling common challenges encountered during the start-up process. The study checked in with more than 500 clinical operations around the world, sharing their concerns and how they have dealt with them in recent months.
Outsourcing-Pharma (OSP) recently spoke about the Pulse Report with Ashley Davidson (AD), senior director for Vault Study Startup at Veeva Systems. She shared details from the study, and what the information contained in the report reveals about the future of the industry.
OSP: Could you share some of the key reasons why condensing the study start-up cycle is important?
AD: Study start-up represents the biggest area of opportunity to speed clinical research. It’s the most resource-intensive phase of a trial but is no faster today than it was a decade ago.
While regulatory requirements have evolved, protocols have gotten more complex, and patient populations become more dispersed, site activation has remained a largely manual process that creates negative downstream impacts on study execution and slows trials. Accelerating study start-up can lead to faster overall study conduct and get new treatments to the patients that need them much quicker.
OSP: What traditionally have been some of the factors keeping studies from being kicked off as rapidly as sponsors would like?
AD: The continued use of spreadsheets and manual processes are slowing trials down. More than 80% of respondents use spreadsheets to manage study start-up, which is likely creating many of the top challenges among sponsors and CROs, including site contracting and budgeting and site identification, feasibility, and site selection.
In addition, sponsors and CROs are using applications for eTMF and CTMS to manage study start-up. The use of these applications and spreadsheets to manage study start-up adds complexity to a highly transactional process and leads to system and information silos that cause delays.
OSP: According to the Tufts Center study you cite, at least some aspects of start-up are taking longer than they did just a few years ago. Could you please share your views on why that is, and how that cycle could be reversed?
AD: The protocols and requirements to run trials are much more complex than they were five to ten years ago because of the rise in precision medicines. Managing study start-up with spreadsheets, manual processes, and disconnected systems adds further complexity and no longer fits the needs of today’s trials.
To speed study start-up, organizations should identify site activation processes they can make more efficient and leverage advanced study start-up applications that can streamline these problem areas. A shift is already underway, with more sponsors and CROs now using purpose-built study start-up applications; we believe this trend will accelerate as companies look for ways to drive greater efficiency across their trials.
OSP: Please talk about why the pandemic has made accelerating start-up even more important.
AD: The pandemic has created urgency to get trials up and running faster. Sponsors and CROs are racing to keep existing trials on track, start new trials to find cures and treatments for the virus, and prepare for a flurry of post COVID trial starts.
As the industry accelerates its timetables for qualified phase 3 trials for SARS-CoV-2, sponsors and CROs are re-evaluating study processes to identify opportunities where they can speed execution and ensure success in the post COVID era.
OSP: Similarly, can you share any ways in which the pandemic has made it difficult to accelerate start-up?
AD: Shelter-in-place orders during COVID-19 have created concerns around patient safety and led to a drop-in enrollment and participation in clinical research. Trial management and execution was significantly impacted because research staff were forced to work from home. Before the pandemic, most companies had an infrastructure that required feet on the ground for study start-up and trial execution.
The industry has quickly transitioned to new remote ways of working. Advanced solutions that enable processes like remote monitoring have helped mitigate some of these challenges. The reality is a majority of studies were delayed or stopped because of COVID. New trial starts, therefore, have been delayed as well.
OSP: Your report talks about opportunities to accelerate start-up through things like optimizing processes, collaborative input and information sharing, and real-time, end-to-end visibility. How can trial teams work toward achieving these goals?
AD: The three pillars of study start-up are people, process, and technology. Trial teams should ensure each is effective and efficient to accelerate site activation. Begin by mapping data and processes cross-functionally to highlight opportunities for improvement.
Equally as important is ensuring stakeholders are aligned. Seek feedback from users early during technology evaluations to guide requirements and maintain clear communication of process and technology changes. Ongoing training and feedback loops ensure long-term adoption and changes to processes that will speed study start-up.
OSP: Is there anything else you’d like to add?
AD: COVID has amplified the challenges experienced during study start-up and placed a spotlight on process improvements. As the industry looks to streamline site activation and speed clinical trials, the focus on connecting people, process, and technology across the study start-up network will continue to grow. The industry is reimagining its processes to drive improved levels of efficiency, quality, and stakeholder engagement that ultimately will have a long-term positive impact on study start-up.