Another way to provide support is by identifying
and defining site-level characteristics or qualities
that will enhance the likelihood of successful study
execution. Having these discussions early will
help sites and study sponsors alike to understand
expectations, and will ensure greater alignment
throughout the trial. In this chapter, we explain how
to work with sites to identify potential opportunities
and challenges in the study, how to use these
insights when selecting sites, and how Parkinson’s
studies undertook this approach to ensure
successful implementation of a complex protocol.
Evaluating Opportunities and
Challenges in Study Design
In clinical research, study sites are unique places
where the science and the participants come
together. By looking closely at what happens at this
meeting place, site personnel can identify potential
challenges or opportunities for a study’s feasibility,
and for its acceptability to patients.
or off-ramps (high frequency of visits, invasive
procedures) that could make implementation
difficult, or discourage participants from
volunteering and/or completing the trial
+ + Opportunities: incorporating into the
protocol ways to make implementation or
participation easier (telemedicine visits,
incentives, provision of transportation, access
to personal health information)
+ + Study feasibility: an indication, based on the
evidence gathered, as to whether or not a study is
viable and stated objectives can be achieved 4
+ + Participant acceptability: the level of effort
(e.g., time, physical and emotional energy) that
a participant would need to put forth in order to
participate in a study, and the potential benefit
perceived from participation (e.g., how much
this will advance the field and additional care
they may receive) 5
+ + Challenges: potential barriers in the protocol
(such as overly stringent eligibility criteria,
lack of accessibility to technical instruments)
4
5
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146075
https://bmchealthservres.biomedcentral.com/track/pdf/10.1186/s12913-017-2031-8?site=bmchealthservres.biomedcentral.com
Chapter 2 — Assessing Opportunities and Challenges
9