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Advocacy and Patient Involvement in Clinical Trials

  • Ellen SigalEmail author
  • Mark Stewart
  • Diana Merino
Living reference work entry

Abstract

Patient engagement in research and clinical trials has evolved over time. Patients are no longer simply passive research subjects but are increasingly being integrated into research teams and protocol review teams to help design, implement, and disseminate clinical trial findings. While potential barriers exist for meaningful patient engagement, mechanisms and methods to effectively engage patients and advocacy groups are evolving, and resources and best practices are continually being developed to assist researchers and patients. Additionally, legislation and regulatory guidance are being instituted to promote patient engagement and ensure it is a routine process for clinical trial development. Developing patient-centered clinical trial designs has led to development of innovative clinical trial infrastructures and statistical methods. Patient advocates and organizations are also increasingly developing their own data sources and clinical trials, which represent unique opportunities for researchers to partner with patient groups to rapidly advance drug development.

Keywords

Patient advocacy Drug development Patient engagement Patient-Centered clinical trials 

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Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.Friends of Cancer ResearchWashingtonUSA

Section editors and affiliations

  • Winifred Werther
    • 1
  1. 1.Director, Center for Observational ResearchAmgen Inc.South San FranciscoUSA

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