Journal article
Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory
Contemporary clinical trials, Vol.152, 107866
05/2025
DOI: 10.1016/j.cct.2025.107866
PMCID: PMC12087796
PMID: 40015598
Abstract
The distinguishing characteristics of pragmatic clinical trials merits special attention when developing a monitoring plan. Pragmatic clinical trials are large in scope; participants are often identified from records or routinely collected data; investigators typically have less control over treatments or interventions; outcome data are often extracted from health records; and study activities are commingled with usual health care. We use lessons from The NIH Pragmatic Trials Collaboratory, which supports the conduct of 32 pragmatic clinical trials, to illustrate some of the challenges and solutions. Challenges include the complexity, quality, and timing of a real-world data pipeline; interventions that are embedded in clinical workflows; and the potential for incidental findings. We recommend regular, rigorous data quality checks, ongoing monitoring of adherence to interventions, and including someone who is knowledgeable about pragmatic clinical trials and novel research designs in the development of Data and Safety Monitoring Plans and Data and Safety Monitoring Boards. Close monitoring by study leaders, independent monitors or and Data and Safety Monitoring Boards is critical for a successful study that produces meaningful results. These experts must also decide about what evidence requires action and/or modification of the protocol and what information and thresholds would lead to a decision to pivot or terminate the trial.
Details
- Title: Subtitle
- Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory
- Creators
- Lesley H Curtis - Duke UniversityStephanie Morain - Johns Hopkins UniversityP Pearl O'Rourke - Harvard Medical SchoolKaren Staman - Duke UniversityJeffrey G Jarvik - University of WashingtonAndrea Cheville - Mayo ClinicDana L Dailey - Saint Ambrose UniversityKathleen A Sluka - Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, Iowa City, IA, USAPatrick Heagerty - University of WashingtonEdward R Melnick - Yale UniversityHrishikesh Chakraborty - Duke UniversityJames A Tulsky - Brigham and Women's HospitalAngelo Volandes - Harvard UniversityGregory E Simon - Kaiser Permanente Washington Health Research Institute
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials, Vol.152, 107866
- DOI
- 10.1016/j.cct.2025.107866
- PMID
- 40015598
- PMCID
- PMC12087796
- NLM abbreviation
- Contemp Clin Trials
- ISSN
- 1551-7144
- eISSN
- 1559-2030
- Publisher
- ELSEVIER SCIENCE INC
- Grant note
- National Center for Complementary and Integrative Health (NCCIH): U24AT009676 National Institute on Aging (NIA)National Institute of Mental Health (NIMH)National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)National Institute on Drug Abuse (NIDA)NIH Office of Behavioral and Social Sciences Research (OBSSR)NIH Office of Disease Prevention (ODP)NIH: UG3AG060626, UH3AG060626, UG3DA047003, UH3DA047003, UG3AR076387, UH3AR076387, UG3DK118748, UH2AT007766, UH3AR066795, UG3AG067593, UH3AG067593, UH2AT007755, UH3MH007755
This work was supported within the National Institutes of Health (NIH) Pragmatic Trials Collaboratory through cooperative agreement U24AT009676 from the National Center for Complementary and Integrative Health (NCCIH) , the National Institute on Aging (NIA) , the National Institute of Mental Health (NIMH) , the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) , the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , the National Institute on Drug Abuse (NIDA) , the NIH Office of Behavioral and Social Sciences Research (OBSSR) , and the NIH Office of Disease Prevention (ODP) . Demonstration Projects within the NIH Pragmatic Trials Collaboratory were supported by the following cooperative agreements with NIH Institutes: ACP PEACE (UG3AG060626, UH3AG060626) , EMBED (UG3DA047003, UH3DA047003) , FM-TIPS (UG3AR076387, UH3AR076387) , HiLo (UG3DK118748) , LIRE (UH2AT007766, UH3AR066795) , NOHARM (UG3AG067593, UH3AG067593) , and SPOT (UH2AT007755, UH3MH007755) . The content is solely the responsibility of the authors and does not neces-sarily represent the official views of the NCCIH, NIA, NIMH, NIDDK, NIAMS, NIDA, OBSSR, or ODP, or the NIH.
- Language
- English
- Electronic publication date
- 02/25/2025
- Date published
- 05/2025
- Academic Unit
- Iowa Neuroscience Institute; Nursing; Physical Therapy and Rehabilitation Science; Neuroscience and Pharmacology
- Record Identifier
- 9984795369602771
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