Opportunities and barriers for pragmatic embedded trials: Triumphs and tribulations.

Abstract

ResultsEmbedded pragmatic clinical trials (PCTs) are set in routine health care, have broad eligibility criteria, and use routinely collected electronic data. Many consider them a breakthrough innovation in clinical research and a necessary step in clinical trial development. To identify barriers and success factors, we reviewed published embedded PCTs and interviewed 30 researchers and clinical leaders in 7 US delivery systems.LiteratureWe searched PubMed, the Cochrane library, and clinicaltrials.gov for studies reporting embedded PCTs. We identified 108 embedded PCTs published in the last 10 years. The included studies had a median of 5540 randomized patients, addressed a variety of diseases, and practice settings covering a broad range of interventions. Eighty‐one used cluster randomization. The median cost per patient was $97 in the 64 trials for which it was possible to obtain cost data.InterviewsDelivery systems required research studies to align with operational priorities, existing information technology capabilities, and standard quality improvement procedures. Barriers that were identified included research governance, requirements for processes that were incompatible with clinical operations, and unrecoverable costs.ConclusionsEmbedding PCTs in delivery systems can provide generalizable knowledge that is directly applicable to practice settings at much lower cost than conventional trials. Successful embedding trials require accommodating delivery systems' needs and priorities.