Sponsors and CROs trying to achieve better enrollment in clinical trials often overlook the most essential stakeholder in the process — the investigative sites that implement the trials and interact with the patients throughout the process. At any given moment, tens of thousands of clinical trials are running across the globe. Given the number of studies currently underway, it is unsurprising that patient enrollment has become a top priority. Ineffectively recruiting patients often delays research, potentially compromising sponsors’ timeline and prompting a dreaded “study rescue” situation. When enrollment is lacking and potential subjects are being excluded left and right, the first thing to determine is whether the study’s protocol is the root of the problem. Sites suffer the most from overly complicated protocols, often putting enrollment, data collection and study fulfillment at risk. Throughout a recruitment process, potential subjects moving through the pre-screening and screening process may be disqualified for unnecessary reasons along the way. Poorly written protocols create unnecessary challenges for sites, confusing investigators and leading to investigators disqualifying ideal subjects, or spending valuable time and resources screening unsuitable candidates. Doing a deep dive diagnostic evaluation of the way your protocol is describing the eligibility criteria, and the way you are teaching your sites how to identify and evaluate the ideal subject for the study can go a long way in preventing and overcoming enrollment challenges. Here are some strategies for improving existing and developing protocols:
1. Perfectly describing the eligibility criteria – Segmentation strategies
Lets face it, protocols may never be perfectly executed, but they can be perfectly written, at least from an inclusion / exclusion criteria standpoint. Split out composite or multi-part criteria vs. lumping things together. If you can’t answer a simple yes or no to each part of your criteria, then the site won’t be able to determine if a potential subject is in or out. There is no shame in having a few more easily-understandable criteria. Lumping things together or worse, describing end of study procedures along with an eligibility criterion creates unnecessary confusion. Segmenting the criteria into the pre-screening vs. screening (post-consent) stages can help optimize the site’s workflow to quickly rule out subjects who have permanent exclusions. Clearly articulating the time-based criteria will help sites to understand how long they have to wait before re-evaluating a potential subject.
2. Job aids
Site-wide comprehension of your eligibility criteria can be improved with one, cost-effective tool – a well crafted I/E criteria checklist. And no, we don’t mean copying and pasting the criteria as written in the protocol. We mean converting this into an easy-to-use checklist that clearly segments out the component parts of the criteria by stage (pre-screening / screening) and by permanent exclusions vs. time-based or temporary exclusions as described above. Make it simple for site staff to easily walk through the criteria in a way that allows them to quickly rule out subjects who don’t warrant further attention from those who should be put on a watch and wait list. The addition can be incorporated into any on-going study without any additional adjustments.
3. Use visuals!
Improving total protocol comprehension across sites does not always require a complete overhaul of the written document, but don’t shy away from flow diagrams or decision trees. If you can map out a process in the protocol, or visualize the steps a site will have to take, you can more clearly describe this in understandable terms in the protocol. These simple infographics enhance understanding with little added effort to the protocol writer. Visually representing key parts of the protocol ensures the important steps are easily translated across sites, and greatly reduces site errors.
4. Site Training
When sites struggle to recruit randomized subjects and the protocol wording is not to blame, it is time to reassess your site training approach. The majority of site training is unoptimized, and a missed opportunity for sponsors and CROs. Effective clinical site training prevents deviations by giving users the chance to learn from the known challenges from earlier studies and other sites. Site staff are not all created equal in terms of their experience so a “one size fits all” approach is a surefire way to set your study up for failure. Pro-ficiency’s Simulation-based online training provides users with training tailored to their individual needs. With Pro-ficiency’s superior clinical site training and analytics to track performance, sponsors can ensure sites are prepared and understand their protocol sufficiently to maximize enrollment and minimize deviations. Preparing site staff by providing them training that guarantees true and total protocol comprehension is the safest way to ensure that a poorly written protocol won’t come in the way of your enrollment and study timelines.
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Beth Harper, Chief Learning Officer at Pro-ficiency, is on a mission to eliminate protocol deviations. Beth brings 35-plus years of experience in clinical research operations to Pro-ficiency, utilizing this knowledge along with her years of creating live protocol simulation training to create cutting-edge simulation training programs at Pro-ficiency. Beth has published and presented extensively in the areas of study feasibility, site selection, patient recruitment, protocol optimization, sponsor/site relationship management and clinical research professional competencies. Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas.