Site Selection
The number and type of procedures, as well as the variation in
recruitment target population, made the S4 research protocol
highly complex. The S4 Steering Committee was aware that
this complexity was a potential barrier to successful study
implementation and determined that careful selection of
clinical sites would help to mitigate this issue. To enhance the
site selection process, the S4 Steering Committee: 1) identified
and prioritized site level characteristics necessary for study
implementation; 2) developed a checklist to evaluate sites in
person; and 3) conducted in-person site visits.
greater success in recruitment and reduced trial delays. This
information was assessed by asking invited clinical sites to
complete a site interest form. The forms were then evaluated
and prioritized by the S4 Steering Committee.
+ + Identified and Prioritized Site-Level Characteristics
The characteristics identified by the S4 team as most critical
to study implementation were:
– – Site personnel experience in implementing clinical studies
that involve collecting biospecimens
– – Site-level infrastructure
– – Access to the population(s) of interest
Each of these characteristics addressed an area of complexity
in the research protocol. Experienced site personnel
provided additional confidence around the ability to conduct
study procedures that were both precise and invasive. Strong
site infrastructure ensured that samples were collected in a
standardized manner and mitigated concerns around data
quality. Access to the population(s) of interest ensured
+ + Developed an Evaluation Checklist
The S4 Steering Committee created a checklist that was
broken out by the three priority characteristics (experience,
site-level infrastructure and access to the population of
interest). Within these categories, specific criteria were listed
that provided a measure of how well the site ranked on that
characteristic (level of experience, type of equipment, access
to storage, etc.). (For more information on this checklist,
email [email protected].)
+ + Conducted In-person Site Visits
S4 Steering Committee members visited each of the sites
under consideration based on their responses to the site
interest form and, using the checklist, evaluated them on the
priority characteristics. Sites were selected to participate
in the S4 study if they adequately met the criteria for
participation, including documented experience collecting
biospecimens from a PD population, site infrastructure
requirements (such as collaborations with gastroenterologists
and ear nose and throat specialists) and recruitment plans for
the population of interest.
Continued on page 16
Table 2. Procedure Completion Rates, S4
Total
Enrolled,
N Blood
Sample,
N (%) CSF
Sample,
N (%) Saliva
Sample,
N (%) Skin
Sample,
N (%) Colon
Sample,
N (%) Gland
Sample,
N (%) Evaluable
Subjects*
Early PD 20 19(95%) 16 (80%) 18 (90%) 18 (90%) 19 (95%) 18 (90%) 18 (90%)
Moderate
PD 20 20 (100%) 18 (90%) 20 (100%) 20 (100%) 20 (100%) 20 (100%) 20 (100%)
Advanced
PD 21 21 (100%) 20 (95%) 19 (90%) 21 (100%) 21 (100%) 18 (86%) 21 (100%)
Healthy
Controls 21 21 (100%) 21 (100%) 21 (100%) 21 (100%) 21 (100%) 20 (95%) 21 (100%)
TOTAL 82 81 (99%) 75 (91%) 78 (95%) 80 (98%) 81 (99%) 76 (93%) 80 (98%)
*Evaluable defined as having contributed at least two out of three biofluids and two out of three biopsies
Chapter 2 — Assessing Opportunities and Challenges
15