July 1, 2021: NIH Collaboratory Leadership Asks, ‘Is Learning Worth the Trouble?’

Cover of the New England Journal of MedicineIn an article published today in the New England Journal of Medicine, Drs. Richard Platt, Adrian Hernandez, and Greg Simon of the NIH Collaboratory discuss barriers to healthcare system participation in embedded research and strategies for improvement.

“We advocate creating a robust national [embedded pragmatic clinical trial] capability to generate evidence to guide decisions by patients, clinicians, health systems, and regulators and respond to urgent national health crises, like COVID-19 or the opioid crises,” the authors wrote.

The article recommends a 4-pronged strategy that researchers and funders should consider to increase healthcare system participation in pragmatic clinical trials:

  • Reimburse for the additional costs of trial participation.
  • In some highly engaged systems, support permanent, reusable infrastructure.
  • Offload research-specific tasks to minimize burden on sites (such as IRB oversight, obtaining informed consent, and mailing medications to participants).
  • Assign and promote reputational benefit for these activities.

In another perspective piece by Simon, Platt, and Hernandez published in the April 2020 issue of the journal, the authors explored why randomized A vs B comparisons remain uncommon in clinical trials.