Introduction

Embedded Pragmatic Clinical Trial Team Composition


Section 1

Introduction

Contributors

Lesley Curtis, PhD

 

Contributing Editors

Karen Staman, MS

Liz Wing, MS

Although a research team typically designs a pragmatic study, it is the healthcare system partners who actually deliver the intervention. Many different people are involved in the conduct of an ePCT, and when designing a trial, an investigator will need to carefully consider the roles of potential team members, including which roles are essential, and who will fill the roles.  Because ePCTs are embedded in health systems, team members from both the research team and the health system must understand and respect each other’s workflow, culture, priorities, and responsibilities (Johnson et al. 2014). Communication is essential, and having a team member with both research and health system expertise can help ensure the success of a PCT (Johnson et al. 2014).

Potential team members can include

  • Principal investigator and co-investigator
  • Health systems leader or executive
  • Biostatistician
  • Lead clinician (e.g., epidemiologist, behavioral specialist, radiologist, pharmacist, physical therapist)
  • Clinical staff (e.g., nurse, operations manager, business manager)
  • IT specialist for EHR data extraction or clinical decision support tool design
  • Professional society leader
  • Site champion/liaison
  • Practice facilitator
  • Research assistant
  • Project coordinator
  • Communications specialist
  • Research participant, patient, or patient advocate

These team members will fulfill different roles throughout the course of the trial, and could assist with trial design, budgeting, site and participant recruitment, communications with patients, trial conduct, and dissemination and implementation of results (Dolor et al. 2014).  Early engagement of the team will help identify workflow issues, ensure the budget is feasible, and help with recruitment of sites and clinicians.

 

SECTIONS

CHAPTER SECTIONS

REFERENCES

back to top

Dolor RJ, Schmit KM, Graham DG, Fox CH, Baldwin LM. 2014. Guidance for Researchers Developing and Conducting Clinical Trials in Practice-based Research Networks (PBRNs). The Journal of the American Board of Family Medicine. 27(6):750–758. doi:10.3122/jabfm.2014.06.140166. PMID: 25381071

 

Johnson KE, Tachibana C, Coronado GD, Dember LM, Glasgow RE, Huang SS, Martin PJ, Richards J, Rosenthal G, Septimus E, et al. 2014. A guide to research partnerships for pragmatic clinical trials. BMJ. 349(dec01 7):g6826–g6826. doi:10.1136/bmj.g6826. PMID: 25446054


Version History

Put content here

Citation:

Embedded Pragmatic Clinical Trial Team Composition: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://rethinkingclinicaltrials.org/chapters/design/embedded-pragmatic-clinical-trial-team-composition/embedded-pct-team-composition-introduction/. Updated November 7, 2018.