In an interview during the program’s Annual Steering Committee Meeting, Drs. Kevin Weinfurt and Greg Simon reflected on cross-Core collaboration within the NIH Pragmatic Trials Collaboratory and opportunities for growth in the future.

More than a decade ago, when the NIH Pragmatic Trials Collaboratory got its start, the focus was on identifying and answering the big questions in terms of how to do research embedded in routine healthcare, said Weinfurt, co–principal investigator of the NIH Collaboratory’s Coordinating Center. As a result, during the founding years, the NIH Collaboratory’s Core Working Groups primarily worked on addressing the big questions that were specific to each Core (eg, ethics and regulatory issues, electronic health record challenges).

After working through many of the early questions, the program’s approach has evolved in recent years.

“As we tackled some of the bigger questions, the new questions we wanted to answer required contributions from across the Cores to address questions in a more comprehensive way,” said Weinfurt.

Many of the new questions that came up for the Core Working Groups originated from the NIH Collaboratory Trials.

“So many of the decisions about pragmatic trials involve compromise,” said Simon, chair of the Health Care Systems Interactions Core. “It is interesting how that compromise is reflected in terms of how and when the Cores work together because each Core has a focus but also needs to account for how an issue in one area of a trial also affects another area.”

For example, Simon said, a project might have a question related to working with the healthcare system, and that question may overlap with ethics and regulatory and health equity issues.

These overlapping issues have resulted in more collaborative work across Cores, explained Simon. “It is important to have these groups that have a focus as long as you realize that there are no sharp boundaries.”

The NIH Collaboratory’s Coordinating Center plays an important role in keeping track of the issues that arise from individual projects and following up with the Steering Committee and Cores.

“There is a web of information that is communicated through the project managers and communications specialists that allows a lot of issues to surface,” said Weinfurt. “Our NIH leaders will often raise issues that they are seeing either within the NIH Collaboratory or on the horizon as something that might be of interest to discuss.”

Looking to the future, Weinfurt said he expects to see more and more opportunities for the Cores to collaborate, find solutions, and create generalizable knowledge, especially as the new Health Equity and Implementation Science Cores ramp up.

“Both the Health Equity and the Implementation Science Cores have a similar reach across all of the various issues that come up for trials. It may be the case that it is very rare to have a Core work alone on a topic in the future,” said Weinfurt.

These collaborations have already been productive, as highlighted by recent cross-Core products tackling important issues:

• Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory
• Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
• Responding to signals of mental and behavioral health risk in pragmatic clinical trials: Ethical obligations in a healthcare ecosystem
• Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials