Rescue study – a scary term that’s far too prevalent in clinical research today. There are many reasons why rescue action is needed for a trial, which are typically identified once there have been major delays.
Setting a trial up for success involves being realistic upfront and spending enough time planning instead of rushing through the steps.
Here we share some of the key takeaways from the free eBook, Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials to help prevent a few common reasons studies need to be rescued.
Communication problems among stakeholders
Sites and sponsors/CROs that struggle to communicate effectively with one another often have a mismatch of what a sponsor thinks they’re asking for versus what a site thinks they have to do. Sponsors must set expectations with sites, especially after changes are made to a protocol.
Of course, both parties should communicate openly throughout the trial and maintain a consistent back and forth rapport. Technology cannot replace relationships; there needs to be a balance between the two. Sponsors must have a clear plan and process for who is engaging and interacting with the site. This includes having a single point of contact that helps triage a site’s questions to the appropriate person.
Otherwise, sites that aren’t able to get their questions addressed in a timely manner can become quickly overwhelmed and frustrated when they lack the adequate resources and support.
Patient enrollment delays
Enrollment often falls significantly behind plan. Sites are typically asked for predictions when they only have a synopsis of the study, which then changes after they’re well underway completing start-up activities. For accuracy throughout a trial, sites need to update their enrollment number after receiving the full protocol details – without being penalized for what they didn’t know in the first place.
By only tracking metrics such as the number of patients enrolled and randomized, sponsors and CROs are not getting the whole picture. Having a plan to track prescreening work and scheduled screening visits help provide insight into enrollment activity that’s happening at the site. Asking for and sharing feedback on difficulties related to enrolling patients can help both parties understand what’s going on and prevent wasted time.
Finally, sponsors should not ignore the sites that aren’t selected. Telling them candidly how they can improve and what you are looking for helps build trust and makes it clear that even though they don’t have enough patients for this trial doesn’t mean they won’t be selected in the future. This also encourages sites to provide realistic, accurate estimates, rather than feeling they need to inflate them just to get selected.
Overly complex protocols
The biggest mistake sponsors can make when developing a protocol is not asking sites to provide input on them. Conduct an early feasibility survey to ask questions about I/E criteria. Have sites tell you how labor-intensive it’s going to be for staff. A task that you think takes sites 45 minutes to complete may actually take five hours. Ultimately, this helps provide improvements upfront before they need to become amendments at a much later date.
The second biggest mistake in protocol design is not taking advantage of the lessons learned from previous trials. Looking back to see if the expectations that were set matched the reality is something that must be built into your process. Identify where inaccurate predictions and prolonged activities occurred, and use this information for future planning.
Of course, it’s critical to help sites working on complicated protocols by providing the training and resources they need. In fact, most sites would like to see sponsors spend more time on training. Sponsors should visit sites early on and spend time demonstrating procedures, checking technology and setting clear expectations.
Not everything goes according to plan
Despite proactive protocol and site performance optimization strategies, unanticipated challenges will come up that require action. It’s critical to have a system in place to help identify the warning signs when an issue needs intervention, before it is too late.
As soon as you know something is off track, and before you start treating the symptoms, be sure to do a root cause analysis to figure out why this is the case.
For more in-depth information on any of these best practices to help prevent rescue studies, download the eBook, Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials.