A Site Point of View into Study Start-up
By Kristin Surdam, Sr. Director, KOL & Strategy @ Florence Healthcare
How do study start up times affect your site? Probably in far more ways than you tend to think! Elongated startup durations impede operations, negatively affect a site’s bottom line, and most importantly, delay access to potentially life-changing therapies for patients.
Start-up timelines have always been important, but the myriad challenges facing sites during this critical phase of a study continue to grow making this important goal exponentially more difficult to achieve within the timelines often set by sponsors. Today’s clinical trials are increasingly complex and exploratory, often creating additional tasks at start-up and throughout study conduct. Yet sponsors and CROs continue to push for sites to do more, with fewer resources (capacity gap, anyone?), and in a shorter amount of time. How are sites supposed to improve time to open metrics when faced with challenges outside of their control? By taking hold of things we do have control over!
Here’s what’s controllable:
- Understand your start-up tasks and resources at the most granular level
- Make Technology Your Friend
- Communicate Early and Often &
- Protect Your Workflows
- Escalate Concerns
Understand your Startup Tasks & Resources
Depending on the size of your site, some of these may be a lighter lift than others. I’ve been with a small independent research site as well as a large academic medical center; each one has its unique challenges.
Take a hard look at your internal study start up processes. Are they clearly documented? Efficient? Are the appropriate people involved? Are the roles and responsibilities clearly defined?
It’s important to fully define each start-up task, its required resources, dependencies, and contingencies. Identify areas where tasks are able to be completed in parallel or delegated to a lower cost resource (where appropriate). For example, during my tenure at an independent site, my coordinator role encompassed many roles you would find at a larger institution: data coordinator and regulatory coordinator in addition to both the clinical and administrative aspects of a clinical trial coordinator. As the workload grew, we brought on a lower cost, entry-level position (rather than another coordinator) to absorb many of the more administrative tasks. This allowed me to focus on activities that directly contributed to our site’s success in terms of enrollment, patient visits, and other income producing activities. Overall, we found a decrease in time to meet our enrollment goals and query resolution, and were able to successfully take on new studies due to increased capacity.
Larger organizations may need to take this a step further and evaluate the need to streamline workflows between departments or roles.
Make technology your friend!
Maybe your site uses too much technology, or maybe you barely use any. Either way, it’s likely this is an area that can be leveraged to increase efficiency in your workflows. Those outdated processes or duplicative tasks identified during your initial process review? Consider the ways good technology can improve or eliminate them.
Assess the currently used systems for opportunities – do any of them have opportunities to speak to each other? Take advantage of open APIs and integrations to reduce transcription errors. Be aware of low to no cost opportunities to utilize current systems more efficiently as well. If you’re unfamiliar with the offerings of your current system, reach out to your vendor to discuss the options for system integrations. Take the time to review for reporting and alert features you may not currently be using -there’s a lot of potential here to trigger activities and monitor progress while avoiding manual efforts.
Personal experience has shown me that sites, sponsors, and CROs all have outdated or redundant processes that lead to inefficiencies and extended timelines to some degree (I’m sure you can name a few from your organization as well). One of the most common pitfalls that cause unnecessary burden is having a lackluster approach to technology. Sometimes this is a function of financial restrictions but is also largely due to the traditional method of sponsor/CRO driven implementations. For example, think about the number of portals or platforms you need to access in a given day just to get through a patient visit… on average, it’s about 6, though my experience has dwarfed that number significantly. How many times has a study required multiple systems that don’t speak to each other, creating redundant efforts for your coordinators? How about the study tech that actually disrupts your workflows? All of these things will affect your startup timelines, delaying patient access to novel therapies. Aren’t patients why we’re all here?
Those sites looking for new or replacement technology should involve end users in demos and discussions – your study coordinators and department managers will have the most insight on what will and won’t help your workflows. For those interested, I’ve recently highlighted more in-depth ways to reduce the clinical trial tech burden on sites and things to consider when choosing new, workflow enabling systems (https://cloud.3dissue.com/180561/181052/211361/WinterInSite2022/index.html?page=8 )
Successfully utilizing technology to eliminate outdated processes and reduce duplicative or manual work will undoubtedly increase efficiency for everyone involved and free up precious time for site staff to attack next steps.
Improve working relationships & communication
Now that you’ve assessed internal workflows, interdepartmental collaboration, and streamlined technology, what’s left? Start-up timelines paint a picture for sponsors and CROs, especially when choosing sites to participate in a trial. But how often are there unnecessary delays that are 100% out of a site’s control? Unfortunately, I’ve worked on a couple of trials where the CRO or sponsor contributed significantly to our start-up delays, most generally through being unresponsive or very slow to respond, having unnecessary demands, or providing inaccurate information. Here are some strategies that worked for me:
Communicate! Early, openly and repeatedly.
From the very beginning, set the tone and expectation for communication. Transparency is your friend. If you know that something in the protocol or vendor workflows won’t work for your site, raise your concern and collaborate with your CRO or sponsor to make it work for everyone.
Protect your workflows
If your site utilizes an electronic storage mechanism for source, regulatory, or anything else that sponsors/CROs need to collect, provide appropriate access. Write it into your site SOPs! Rather than duplicating work by saving documents in multiple places or downloading from one system just to upload into another, work with your sponsor representative to determine how they can meet you where you are with your workflows. Ensure you’re able to articulate the benefits to them when explaining this compromise. Less time tackling duplicative tasks means more time for other activities, reducing timelines all around.
Escalate concerns throughout CRO or sponsor as necessary
If, at any time during start-up (and throughout the study) you find yourself having to follow up with your CRO/sponsor contact regularly just to get what you need – escalate! Reach out to a Clinical Lead, Project Manager, or anyone else at the organization. It’s likely that those in charge of the project are not aware of the frustrations you’re facing and want to see things move quickly as much as you do.
There will always be aspects of study start-up sites are unable to control. Staying on top of the things we can control will contribute to reduced timelines, increased capacity, happier sponsors, and likely additional opportunities moving forward. Those opportunities pave the way for your site to be more selective about the studies you choose to activate. Rejecting studies that may not be a good fit for your site will protect your site operations and team morale. Whether you’re currently with a small independent site or a large academic medical center, take a fresh look at your study start-up practices and identify the areas you may be able to affect positive change for your organization.
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