– – Research Assistant
– – Registered Nurse/Coordinator
+ + Patient representatives: individuals or
advocacy groups that represent patients
participating in the study. To identify these
representatives, start by making a list of patient
or advocacy organizations that have access to
your target population, and will have insights
into this population’s attitudes and motivations
toward participating in research. Once you have
identified these groups, gauge their interest
in consulting on your protocol as part of a
key stakeholder working group. One or two
individuals should be invited to participate and
may include:
– – Engaged patient, such as a Fox Trial Finder
ambassador or a Parkinson’s Advocate in
Research activist
– – Community liaison, such as a social worker, or
health educator
– – Communications specialist, such as a public
relations coordinator or manager, or a social
media analyst
When engaging key stakeholder groups make sure
to: 1) qualify the type of input and perspective
you are seeking; 2) discuss the potential role
and/or individuals who are best-suited to contribute;
and 3) explain the requested level and length of
commitment for participation.
Gathering Input on Key Protocol
Components
Key stakeholder input can be invaluable in
these areas:
+ + Recruitment and Enrollment
– – Can eligibility criteria be expanded to
include more participants? If so, can this be
accomplished without jeopardizing study
design or key regulations?
– – Do sites have access to the target participant
population? If so, what are the planned
outreach methods?
– – Will a randomized control design affect the
ability to recruit? What is the treatment that
the control arm will receive, and will this be
acceptable to participants?
– – What, if any, side effects might participants
experience from the study drug? Will this
deter participation?
+ + Study Procedures
– – What does the site workload entail? Could the
order of assessments or schedule of activities
be streamlined without decreasing scientific
rigor or causing harm?
– – Is it feasible to implement a blinded or
double-blinded study? Would this increase
burden or workload on sites?
– – Would additional study personnel be required
to facilitate implementation of the schedule of
activities requested?
– – What is the study burden on participants?
Could this be reduced? If so, how might this
be accomplished while adhering to the
study design?
– – How frequent are participants’ study visits?
Can any be conducted at home or online?
– – A re the procedures physically or emotionally
taxing for volunteers or their care partners?
Are there supports (e.g., financial,
educational or physical) that can be
provided to facilitate participation?
+ + Trial Sites
– – What are the most and least important
qualifications for clinical trial sites?
– – How are qualifications weighted and evaluated
during site selection?
– – A re there particular sites, institutions or
geographic regions whose participation would
add scientific, strategic or oper ational value?
– – A re there any plans to contract or
subcontract with additional sites if primary
site(s) is/are unable to recruit target
participant population?
*For more information on the Fox Trial Finder Ambassador program,
email [email protected].
Chapter 1 — Clinical Research Design and the Participant Journey
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