Chapter 1
Clinical Research Design and
the Participant Journey
Objectives
+Describe
+
the participant journey and how it informs clinical trial design
+ + Characterize key stakeholders and how they can provide insights into the
participant journey
+ + Outline steps in the formation of a key stakeholder working group and
critical junctures for input
+ + Share a case study that illustrates how a key stakeholder group can be used
to improve clinical trial design
In recent years, innovations in clinical trial design, combined
with new technologies, have made it easier for patients to
find out about and participate in research. At the same time,
a trend toward including more stakeholders in trial design
has led to novel recruitment methods. More and more,
clinical trial design puts patients at the center, focusing on
their needs — increasing understanding of how to engage
research participants and also what discourages participants
from joining or completing a trial. 1,2 This chapter explains
the importance of key stakeholders for understanding the
participant journey, and outlines ways to obtain stakeholder
input for a patient-centered clinical trial design process.
1
2
https://www.biopharmadive.com/news/5-trends-changing-clinical-trials/437416/
http://www.appliedclinicaltrialsonline.com/perspectives-past-present-and-future-clinical-trials
Chapter 1 — Clinical Research Design and the Participant Journey
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