By Jennifer Sheller, Head of Monitoring Excellence, Trial Diversity & Site Engagement, Global Clinical Trial Operations, Merck
Recent site surveys and feedback from industry conference attendees show that sites are looking for a collaborative relationship with sponsors to drive more productive conversations and foster better-informed decision-making.
In fact, an SCRS site study dashboard white paper reported
that 76 percent of sites never receive feedback from sponsors on their study
performance, except for recruitment metrics. Survey respondents noted that they
needed actionable performance information early in the process in order to take
quality to the next level.
What features should sites be looking for? What would help sites gauge their performance? Here are some considerations that both sites and sponsors can deliver:
Organized and visual presentation: Compelling data
will always be more impactful if it is clear and engaging. Relevant key
performance indicators (KPIs) depicted in a convenient report will provide
sites and CRAs with a vantage point for charting progress and focusing on areas
to improve. This can include enrollment, start-up timelines, data entry, query
resolution and protocol deviations.
Real-time tracking: Sponsors and sites that can share
insights throughout a clinical trial develop strong partnerships. For example,
a report that shows patient screening and randomization metrics allows a site
to monitor enrollment progress, highlighting how many patients were targeted
before the activity began, the current number of patients in a particular study
and how this compares to other sites in a given study.
Transparent benchmarking: It is an advantage for
sites to know how their own performance compares to other sites within a given
study at the country, regional and global level. Equipped with this
information, sponsors can discuss specific strengths and collaborate with sites
on areas for improvement to take action.
Insights to elevate discussions: CRAs can generate reports to proactively prepare for site visits, help sites interpret their data and anticipate site needs throughout the study. By continuing to update reporting based on end-user feedback, sponsors can make site conversations as effective and efficient as possible.
Sponsors should offer a unique perspective and support to boost clinical research sites’ operational excellence. A site’s clinical trial performance data, when shown visually and in the context of other study measures, can enhance sponsor-site collaboration. This is critical to the identification of issues and collaboration to secure quality and compliance and manage expectations.
Merck is committed to providing access to this robust
information. Site personnel who would like to learn more can ask their Merck
CRA about Site Health Check, a reporting tool designed by sites for sites to help
focus on what matters—ultimately resulting in better quality research and
operational excellence.
