Fast Tracking Study Start-Up from Site Selection to First-Patient Enrollment

Ashley Davidson

Life sciences companies are looking for ways to get clinical trials started and completed with greater speed and efficiency. The development cycle for a new product typically takes eight years, making clinical trials no quicker today than a decade ago.¹ COVID-19’s disruption of clinical operations has made trial starts and execution even harder, delaying more than 1,700 studies.²

There is, however, change underway as the industry adopts novel approaches to keep existing trials on track and get new studies up and running faster. As leaders rethink trial processes, study start-up is an area that is a significant accelerator.

Study start-up accounts for 61% of the time spent on a clinical trial³, likely due to delays in the early steps of research. As organizations look to fast-track study start-up, identifying areas for improvement, mapping processes, evaluating systems to find the right technology, and proactively managing change can help speed trials.

Identify areas for improvement

In a recent survey, 100% of sponsor and CRO respondents said they need to improve study start-up.⁴ Study start-up is one of the most time and resource-intensive areas in clinical research, and incremental progress can significantly impact how studies are run.

The teams executing study start-up processes can be key sources for innovation. At the 2020 Veeva R&D Summit, Amy Abernethy, MD, PhD, principal deputy commissioner and acting CIO of the FDA, said innovation happens at “the intersections” where “voices at the table represent different backgrounds, disciplines, and ideas.”

Bringing start-up teams and stakeholders in supporting areas together can drive new ways of working and help leaders prioritize which study start-up activities to optimize first. Study start-up impacts other clinical processes so including the teams doing the work every day in planning sessions provides insights to figure out what is effective and what is not quickly. Identifying areas for improvement is vital to streamlining processes and speeding up cycle times.

Map out processes to increase efficiency

With insights into the causes of delays and redundant user tasks, organizations can evaluate end-to-end study start-up processes. The objective is to understand how each step fits together and impacts one another.

Sponsors and CROs cite that site identification, feasibility, and selection is one of the top challenges in study start-up (see Figure 1 below), causing delays and accounting for most of the cycle time in the start-up phase. New technology isn’t necessarily a quick fix. Mapping out the processes in these problem areas before evaluating solutions sets a foundation for change.

Figure 1: Biggest Challenges with Study Start-up Processes (Veeva)

For example, examining the impact of the protocol authoring team’s processes on the site identification team and the triggers for identifying sites at the correct times can help uncover process issues. Looking at processes holistically helps teams and business owners identify opportunities to digitize or automate, simplifying study start-up.

Evaluate systems for new, faster ways of working

The processes and systems used to manage study start-up make it harder to speed execution. Heavy reliance on manual processes and general-purpose tools and systems leads to inefficiencies and lack of transparency.

Spreadsheets are the predominant way sponsors and CROs manage study start-up, and others use applications for clinical trial management systems (CTMS) and electronic trial master files (eTMF) (see Figure 2 below). Relying on manual-based processes and applications built for other areas adds complexity to early trial processes. These applications cannot handle the rigor or meet the requirements of study start-up.

Figure 2: Tools Used to Manage Study Start-up (Veeva)

The use of multiple applications to manage study start-up perpetuates a lack of visibility across end-to-end study start-up processes, causes delays that have a substantial downstream impact on investigative site activation and study conduct, and can prevent a trial from ever getting off the ground. The learnings from aligning teams and mapping processes can guide leaders to make informed technology decisions.

Features that can simplify study start-up include automated workflows, imbedded process knowledge, and reports and visualizations that help prioritize critical start-up activities. Technology with digital document management and filing can also lessen the burden on sites and speed document collections and submission. A modern study start-up application can help eliminate data and workflow silos, making it easier for start-up teams to do their jobs.

Proactive change management to ensure user adoption

Closely collaborating with the people doing the work, simplifying processes, and selecting the right technology, companies can speed study start-up. The final step is training users on new processes and solutions.

A proactive training and change management approach is critical to ensure people are proficient with new solutions and processes. Identify change champions within your team early on to be the go-to person for questions. Provide training sessions that showcase what will be changing, how changes will make the users’ job easier, and what is not changing.

FAQs and videos can also help teams understand how modernization efforts impact their roles. Provide a clear path for users to submit feedback, such as successes and key learnings. By asking people to provide comments on their experience, companies can build knowledge over time to further improve processes for faster study start-up.

Speed study start-up to accelerate clinical research

Study start-up presents a significant opportunity for the life sciences. This area is especially important now that the industry is looking for ways to keep existing trials running, speed new studies, and prepare for a major wave of post-COVID-19 trial starts.

Sponsors and CROs are leading the shift to innovate early trial processes and speed clinical research. The path to modernizing study start-up begins with identifying areas of improvement, mapping out processes, evaluating systems, and implementing change-management techniques proactively. Taking this holistic approach can position organizations to accelerate study start-up from site identification to enrollment.

References

1. PhRMA, Biopharmaceutical Research and Development: The Process Behind New Medicines, 2015.
2. The Grey Literature, Clinical trials stopped by COVID-19, 2020.
3. Veeva Systems, Study Start-up Pulse Report & Accessing Post COVID Readiness, 2020.
4. Veeva Systems, 2020 Unified Clinical Operations Survey Report, 2020.

Ashley Davidson, Senior Director, Vault Study Startup, Veeva Systems