Two manuscripts recently published in peer-reviewed journals offer researchers a glimpse into the opportunities and challenges for novel pragmatic trials like Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE), a demonstration project of PCORnet®, the National Patient-Centered Clinical Research Network. The publications highlight separate, but equally important, topics of interest in pragmatic research: maximizing clinician engagement and navigating institutional review board (IRB) challenges.
ADAPTABLE, a multicenter, open-label, randomized controlled trial, is the first interventional study conducted across PCORnet. The ADAPTABLE study team is using PCORnet’s broad and rich data resources to examine high-dose versus low-dose aspirin for prevention of heart attack and stroke among patients with cardiovascular disease.
One manuscript published in Clinical Trials shares how ADAPTABLE has used new approaches to break down traditional barriers to clinician engagement, such as time limitations, insufficient research infrastructure, or lack of research training. While clinician engagement is important in all clinical research, it is particularly essential for pragmatic trials, which are conducted in real-world clinical settings and require that researchers and clinicians operate toward shared goals. The paper assesses how tactics like empowering clinician champions, periodic newsletters, and coordinated team celebrations fared in regard to their merit and utility in a pragmatic trial setting.
Novel pragmatic methods like those deployed in ADAPTABLE are intended to improve the participant experience, but unfamiliar approaches can also spark new — and justified — considerations for IRBs that can potentially make the evaluation of these studies more complex. A recent manuscript published in Trials explores unforeseen challenges the ADAPTABLE team encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination, as well as how the study team pivoted in response. It offers lessons in upfront planning to mitigate these challenges in future pragmatic research.
Together, manuscripts like these are providing the research community a valuable template for pragmatic studies, which are important to help us understand how interventions perform in the real world. Full results from ADAPTABLE are expected in May 2021. Be on the lookout for more PCORnet-enabled research in the coming months!