The Association of Clinical Research Professionals

Best Practices for Communicating Benefit, Risk, and Uncertainty in Medical Device Clinical Trials

Effective communication is fundamental to the ethical design and conduct of clinical trials. Research participants cannot make an informed decision to participate in a clinical trial without clear communications from the research professionals supporting the trial.

The evidence-based practices covered in this webinar recording will help clinical research professionals in the conduct of their clinical trial activities, including patient education and informed consent. It is important for clinical research professionals to learn that effective communication is not simply parroting information to patients and hoping they understand, but deliberately engaging with patients to present information in a way they can understand and use that information to make clinical decisions.

Upon completion of this continuing education program, participants should be able to understand and identify:

  • Define benefits, risks, uncertainty, and patient preferences regarding the use of medical technology
  • Understand the evidence-based practices for communicating the benefits, risks, and uncertainty regarding medical technology to patients and providers
  • Identify best methods for benefit-risk communication to patients and how such information can be most effectively developed

Stephanie Christopher,MA, CCRC, FACRP,  Associate Director of Research Programs, National Organization for Rare Disorders (NORD)
Liliana Rincon-Gonzalez, PhD, Program Director, Clinical Science, MDIC
Scott Goates, Ph.D., MBA, Senior Advisor, Health Economics and Outcomes Research, Abbott
Mimi Nguyen, Health Sciences Project Manager, FDA Center for Devices and Radiological Health

Approved for 1.0 ACRP Contact Hours | Expires December 16, 2024