A new commentary in JAMA highlights a significant challenge in healthcare: the gap between the results of pragmatic clinical trials and their actual implementation in healthcare systems. The authors, Richard Platt, Hayden Bosworth, and Gregory Simon, from the NIH Pragmatic Trials Collaboratory, argue that changes are needed to ensure research findings are more readily adopted into practice.
The commentary suggests that clinical trials need to be faster, ideally completed within 2 to 3 years, to maintain relevance in rapidly evolving healthcare environments. Furthermore, trials should prioritize outcomes that are meaningful to healthcare system leaders, such as cost-effectiveness and subgroup analyses, to better align with their decision-making processes.
Another key point raised is the level of evidence required for change. The authors propose that healthcare system leaders may not always require the traditional threshold of P < .05 for rejecting the null hypothesis. Instead, they might consider results from Bayesian methods and interim analyses, allowing for more flexible and adaptive decision-making.
"We believe it is possible to make pragmatic clinical trials of policies and procedures more useful to delivery systems by accommodating their priorities, introducing flexibility in the level of evidence trials require, shortening the duration of planning and implementation, addressing system leaders’ interest in multiple outcomes and subgroup analyses, encouraging modification of protocols during the implementation phase, and by providing timely interim analyses that can guide decisions about continuing or modifying an intervention," the authors wrote.
The commentary stems from an NIH Pragmatic Trials Collaboratory workshop in 2023, which focused on accelerating the translation of evidence into practice. The workshop explored the cycle of evidence generation and the decisions made by healthcare system leaders when implementing findings from pragmatic clinical trials.
