For companies conducting clinical trials, study startup remains a major hurdle. Over the past 10 years complex protocols, difficulty in finding patients who meet inclusion and exclusion criteria, protocol amendments, and competition for sites have impacted the startup process. As a result, the activities associated with startup, including site identification, feasibility assessment, and budgets and contracting have become a priority improvement area for pharma.
A new report from Industry Standard Research (ISR) titled, eClinical Technology Adoption and Challenges in Study Startup, shines a light on the issues surrounding startup and how eClinical technologies are helping companies overcome these challenges. I spoke with the report’s author, Andrew Schafer, president of ISR, about the challenges that exist with startup and how companies are adapting.
Ed Miseta: Tufts did a study in 2017 that indicated clinical operations teams were ‘satisfied’ with their processes. It also found those companies that were adopters of technology outperformed their competitors. Who did you survey and what did you find?
Andrew Schafer: The study we performed in 2018 focused on the plans, barriers, motivations, and metrics regarding the deployment and integration of clinical systems (e.g. site start-up, CTMS, IRT) and how these technologies impacted the working relationship with sites. We interviewed 262 highly-qualified respondents from sponsors of various sizes (n=187) as well as CROs (n=75). All-in-all, we collected data from 194 unique organizations for this research. While the number and breadth of the findings are too numerous to completely cover here, one major take-away was that when implementing a technology system, you must get everyone on the same page in terms of what the goals of the technology implementation are. The research respondents had very diverse rationales for why they undertook or are undertaking technology implementations.
Miseta: What is the extent of technology adoption in site collaboration?
Schafer: We found that, on average, respondents were using approximately four different clinical applications for their site collaboration activities. Respondents indicated they are increasing their use of full-service providers for improving the site collaboration process and the main challenge they are trying to overcome is site contracting and budgeting.
Miseta: Is technology adoption serving as a catalyst for other organizational changes, such as interdepartmental collaboration (breaking down silos) and outsourcing oversight?
Schafer: That’s actually a two-part question, so let me break it down into the “internal” part and the “external” part. If we look at how technology is impacting internal operations, what we see is that it is definitely having a large impact. In fact, the most important element for successful technology implementation for site collaboration cited by respondents was “Facilitate efficient start-up (i.e. parallel vs. sequential work) across departments by utilizing a workflow application.” From an external perspective, the research did not dig deep into the cost of outsourcing oversight, but we did find that over half of the sponsor respondents (59%) indicated there were barriers to successful outsourcing. The two main reasons cited were “Difficulties in identifying qualified CROs” and “Cost of outsourcing is higher than insourcing.”
Miseta: Your study focused on the diffusion of eClinical technology in the study startup phase of clinical trials. Patient recruitment remains a major obstacle for many companies. Were you able to gain an understanding of how technology is used to assist with patient recruitment?
Schafer: Technology is definitely assisting in this area, and we found that the three most important aspects that can speed patient recruitment in clinical trials were “Better site selection (i.e. selecting sites on current data),” “Better site identification (i.e. finding potential sites based on historic data),” and “Better site engagement (i.e. sites that are actively engaged are also likely to have subjects to enroll).”
Miseta: What barriers are companies facing in adopting eClinical solutions to study startup?
Schafer: That is a really good question and answering it was one of the main goals of the research we performed. Respondents identified three main barriers to adoption of eClinical systems for study startup. Those barriers include “Complexity of adopting new systems (e.g. deployment time, training, ease of use, SOP changes),” “Lack of integration with existing systems,” and “Internal resistance to change.” From a higher-level view, we also learned that “Internal resistance to change,” “Lack of executive support for change,” and “Unavailability of budget to pursue investment in technology” were highly ranked. These results indicate that specific projects do suffer from the lack of executive support or budget for change.
Miseta: For the companies that are implementing study startup projects, how are they dealing with change management?
Schafer: Change management is always a really difficult thing to oversee because you have both process and technology changes happening at the same time. Add to that the fact that employees are generally resistant to change, and you begin to understand why there are issues with properly managing the change. Two of the biggest barriers or resistance areas for internal staff were “Having to maintain old systems in addition to new systems” and “Belief that current systems and processes are working adequately.” So, on the one hand, they don’t feel the change is necessary, and at the same time they believe the change will actually create more work for them.
That being said, one of the ways management and employees are trying to deal with the change is by measuring the results/progress of the technology implementations. The top two measurement criteria cited by respondents were “The use of Key Performance Indicators (KPIs)” and “Meeting established goals (e.g. cycle time reductions).”
Miseta: Your research seemed to show an industry at the crossroads of change. Companies recognize the need to modernize their technology and processes to address entrenched bottlenecks in starting clinical trials. But at the same time, they are struggling to break free from the status quo, which blinds them to opportunities to work with new sites. How do they break free of this mindset?
Schafer: As I mentioned earlier, this is a very complex web. But, given the challenges cited by respondents, the implementation of site start-up technology should have a noticeable positive impact on trials. Still, that does not make the implementation process any easier. First you have to get senior management buy-in and budget. Then you need to collect feedback from all of the stakeholders in the startup process, including your clinical sites and end-users. Next you have to select, implement, and integrate the new technology. In most cases, you will have to do this while maintaining existing systems for a while longer. Finally, you must measure the results of your implementation.
Miseta: Any advice for the operations people considering a technology implementation?
Schafer: My advice, based on the data we collected, would be to make sure everyone is clear as to the goals of the technology implementation. For example, is the main goal to save money, and if so, where will those savings occur? If your goal is to increase quality, how do you define and measure it? If your goal is to reduce cycle times, make it clear what processes you’re referring to. Only after answering all those questions will you be able to set metrics to measure your results. What gets measured will get done.
For those interested in viewing the full report, it can be downloaded here.