Trial leaders recognize traditional site initiation processes often lead to excessive delays but have struggled to adapt and improve.
They know that delays in study startup mean patients must wait even longer to access critical treatments. They also know that delays in activating sites can add between $600,000 to $8 million in excess costs per day and that the time required to activate a trial is inversely related to its enrollment rate.
The implications of a bad Site Initiation Visit (SIV) are real and growing.
In addition to the upfront costs driven by preparing bad slides, expensive CRA travel, and hours of wasted training – multiplied across each site – a poorly executed SIV produces:
- High screen failure rates
- Protocol deviations, which can compromise study results and potentially endanger participants
- Activated sites that fail to enroll a single patient
- Lack of confidence in effective study conduct
- Preventable delays and frustration for CROs, sponsors, and sites alike
Yet despite this knowledge and the extra budget they reserved for anticipated problems, it’s reported that after a poor SIV 85% of trials still end up delayed. Even more concerning, the delays caused by poor site initiation practices are entirely preventable.
The growing complexity of today’s trials and increasing administrative burdens in maintaining an effectively trained workforce have only magnified these issues.
Is there a better way?
- Changing behavior is hard but achievable. Changing behavior can be a difficult and complex process for anyone, and the same is true for clinical trial leaders. Despite the best intentions and efforts, many leaders struggle to implement the changes required to accelerate startup timelines and avoid downstream issues. These obstacles can be overcome.
- Resistance to change: People often resist change, even when they know it is for the best. They may be attached to the current process or fear the unknown. Clinical trial leaders may face resistance from team members and sites who are uncomfortable until they more clearly understand the benefits new processes or technologies can provide.
- Lack of understanding: Clinical trial leaders may not fully understand the behaviors they are trying to change, or the root causes of the challenges they are facing. The underlying cause of many downstream issues, from high screen failure rates to protocol deviations, can be traced back to ineffective training practices during site initiation. Protocols are becoming increasingly complex and require more diligent trial team preparation, not less.
- Limited resources: Clinical trial leaders may believe they lack sufficient resources, such as the time, staff, or budget to adopt new processes and technologies or to provide sufficient training. In reality, these beliefs are misguided. They simply lack the right tools and methodology to change site initiation practices within a tight budget or timeline.
- A typical initiation process wastes valuable time. We know that every site is different, yet most are run through a singular one-size-fits-all process, site after site. Forcing each site to spend hours listening to a CRA reading the same set of bad PowerPoint slides is a painful experience and wastes valuable time, especially when each site arrives at an SIV with varying levels of preparation, capabilities, and experience.
Wouldn’t it be better to deliver a more engaging and effective experience, one that tailors the training and experience to each site’s individual needs and maximize everyone’s time (the site’s and project team’s)?
Let’s imagine a different approach where we give sites back valuable time and instead invite them to participate in an on-demand training experience they can access whenever time permits and from any device in the days and weeks ahead of a planned (and much shorter) SIV. Now instead of being asked to listen to hours of bad PowerPoint presentations, they are engaged in a much more interactive experience built around a digital version of the study documents that are tailored to address their specific role and responsibilities in the study. This provides a far more flexible approach designed to meet the needs of the site. Now site personnel can spend less but more focussed time consuming and understanding the information most relevant to them.
In this approach each trial team member’s knowledge and confidence in performing their role can be dynamically assessed as they engage in the learning experience. On a training and analytics platform like Ready, the unique behavioral data generated as sites engage in the interactive experience reveals which sites and personnel are truly ready to screen and enroll patients and ultimately perform the study and which are not, and why. Using these predictive insights, CRAs are far better informed ahead of the planned SIV enabling CRAs to tailor their interactions to the specific needs and questions at each site during a much shorter visit (in-person or virtual).
Such a re-imagined process is quickly becoming the new gold-standard, is proven to reduce time spent in SIVs by 90%, and often resembles this flow:
- Too much is asked of CRAs. A process that is overly dependent on its CRAs (even highly experienced ones) is prone to issues and preventable delays. CRAs are expected to conduct the Site Initiation Visit (SIV) and deliver study training and monitor the site, but they are trained to be clinical monitors not clinical experts or instructors. They often lack the protocol knowledge and instructor led training experience to lead an SIV. The result is poorly delivered study training that fails to prepare site staff and too often leads to high screen failure rates, missed enrollment milestones, protocol deviations, and costly delays.
CRAs can play a critical role in activating sites, but we should empower them to thrive in a role better suited to their actual skills and experiences.
In today’s AI driven and digital world, CRAs can and should be better trained and certified to meet clinical research competencies, as established by ACRP and others, before they are even asked to demonstrate proficiency in a specific study protocol. CRAs should then have access to critical insights that guide how and when they interact with, upskill and remediate, and monitor a site. Preparing and equipping CRAs with the right information before visiting or monitoring a site will enable them to perform their intended role at a much higher level.
Site initiation doesn’t need to waste time and resources, but it clearly needs to meet the standards established in ICH E6 R3 for quality in designing and conducting clinical trials. Yes, change is hard but trial sponsors and CROs no longer need to accept preventable delays and missed study endpoints. They can accelerate the right behavior change by understanding that better tools and methodologies exist that can reduce burden across study teams and accelerate trial timelines.