Clinical oversight during the COVID-19 pandemic: 5 reporting lessons learned
Clinical trial sponsors need the ability to monitor the health of their study or portfolio of studies on an ongoing basis. In times of crises, this becomes a challenging task, as the rapidly evolving situation might render standard reporting tools inadequate and outdated. The Xcellerate® technology suite has been developed with the goal of accommodating the diverse reporting needs of sponsors that run trials with us, but the COVID-19 pandemic has been a unique situation.
As study teams and leadership were facing the pandemic rapidly spreading across the globe, the Data and Technology team quickly developed a data reporting dashboard to help monitor and understand the impact of the pandemic on the clinical trials. Developing new reporting for this unprecedented situation provided several lessons learned that can help sponsors manage the transition to the “new normal” and elevate trial oversight and the technology required to support it in the future.
1. Realigning metrics
As the COVID-19 pandemic started to affect clinical trials, it became evident that different metrics were required for trial oversight. While study milestone metrics are typically an extremely important measure of study conduct, many studies were paused or slowed down during the pandemic and it was unclear when they would start up again. It was, therefore, less important to track metrics related to meeting original study timelines, but rather focus on essential metrics such as patient access to clinical trial sites and study medicines. During the pandemic, many sites had to restrict in-person visits and had to interact with patients remotely. As sites became fully operational again, study teams needed to know the best way to prioritize the work to get back on track.
2. Assessing status on a country and regional level
Since the pandemic impacted different parts of the world at different times, it was critical to have the capability to assess the impact on ongoing studies by region and/or country level, both individually and across regions/countries to compare performance and predict changes in metrics as the pandemic evolved. The Xcellerate team worked quickly to develop tailored regional and country level views in the Xcellerate Portfolio Dashboard to meet the operational and regulatory needs.
3. Importance of data collection
The key to meaningful and powerful visualizations is timely and accurate data collection. As a result of the pandemic, understanding which sites were open to clinical research associates (CRAs) and which sites were open to patients became critical. In the pandemic’s early stages, this information was captured in temporary and inefficient ways, such as spreadsheets by localized teams. This method also was error-prone and made it impossible to tell which data was missing. To remedy this, the Data and Technology team created a web-based data collection tool within 3 days that prepopulated all of the expected sites. This immediately reduced errors, enabled tracking of missing data and collated all of the data collection to one tool.
It also became very important to track patient visit compliance during the COVID-19 situation. For studies that had been tracking this information already, it was powerful to be able the pinpoint the high-risk areas where patient visits were dropping. However, not all study teams had been collecting this information in a detailed manner; the reason for this was that some studies had started prior to this tracking technology being implemented. In these cases, the data was too sparse for meaningful analysis. The decision was made on a case-by-case basis whether to add the studies to the patient visit tracking tool retrospectively. Due to time and competing priorities, not all studies could be added. The team learned that it is worth the investment to bring all studies of long duration on to the latest technology as it becomes available rather than only implementing new tracking tools on new studies.
4. Creating a library of risk metrics
As the pandemic continued, it came to light that different trial sponsors we support were finding relevance in different metrics. For example, one client was interested in tracking the disposition of a study drug, whereas another was most interested in lab result as a patient safety parameter. Countless requests were received for these types of metrics that could not be used across all of the studies, as they were not universally relevant. The team decided that they needed to put processes in place for determining: 1) the criticality of the metric; and 2) how these metrics will be relevant to support sponsors’ needs.
It was also observed that what was a critical threshold for one trial may not be as critical for another trial. For example, while the threshold for data entry timeliness is short for a COVID-19 trial, the same metric may have a much longer threshold for an oncology trial. It became necessary to create a strategy to incorporate specific thresholds and aggregate these metrics so they would be meaningful at a higher level and would be consistent across a sponsor’s program.
5. System, development and testing flexibility
As new metrics and reporting features were requested by the operational teams to manage studies during the pandemic, the Xcellerate solution was quickly re-configured and enhanced to meet the new demand. The support team introduced new efficiencies in testing and release through agile processes. This ensured that sponsors could get the reporting they needed for their studies as soon as possible. In the end, it was the flexible and configurable design of the system and the rapid development approach embraced by the team that demonstrated how study reporting and managing needs can be adapted to the changing study environment in a fast-paced and dynamic way.
Learn more about how to integrate data sources and report on metrics and key performance indicators (KPIs) to enable study teams to quickly ascertain the health of a study or portfolio of studies in adverse circumstances like COVID-19 in the on-demand webinar – “Achieving Successful Clinical Trial Oversight During Global Crises: Measuring the Impact Across a Sponsor’s Portfolio.”