Open-ended responses
We asked a series of open-ended questions to elicit more detail
regarding the nature of operating in multi-network environments.
First, we asked survey respondents (i.e. CRS coordinators) to
articulate the specific areas that they found most challenging coordinating
with their CTU. The most prominent themes identified
from the responses following the qualitative analysis described
earlier included challenges related to: (a) the allocation and consolidation
of resources; (b) communications between networks;
(c) limited staff and funding to work on multiple trials;
(d) network-specific differences in regulations and SOP requirements;
(e) maintaining the quality of community engagement
efforts; and (f) substantive differences in protocol approval, activation
and implementation procedures2
.
Second, we asked CRS coordinators to describe areas where
multi-network affiliations allow for the consolidation and costsharing
of research functions based on their experiences at their
site. The majority (80%) of respondents at multi-network CRSs
reported that multi-network affiliations do allow for the consolidation
and cost-sharing of research functions. Thematically,
respondents indicated consolidation and cost-sharing could be
found in: (a) flexible staffing and movement of staff across networks
for protocol implementation; (b) common laboratory functions
and processes; (c) staff education and training; (d) outreach
and recruitment of study participants; (e) sharing of resources such
as vehicles, facilities, clinic materials, and equipment and security;
and (f) pharmacy operations.
Finally, we queried CRS coordinators about their suggestions
for increasing the efficiency or performance of multi-network
CRSs. Respondents indicated that streamlining standards and
requirements, including data management and reporting processes,
and utilizing common CRFs across networks could aid in
increasing efficiency and performance. From the CRS coordinators
perspective, this could be facilitated through the use of informatics
technologies to improve performance and efficiency,
including moving towards paperless data collection. Furthermore,
ensuring consistency of policies and procedures across networks,
as well as consolidating regulatory processes and harmonizing
oversight mechanisms across networks, were viewed as potential
sources for improvement.
The consolidation of protocol activation methods was also identified
by CRS coordinators as a means to increase efficiency and
improve performance, and it was consistently emphasized in combination
with suggestions for working under a single crossnetwork
coordinating centre. Reducing the duplication of effort
across networks, such as synchronizing lab procedures and
requirements across networks and by consolidating some services
at the sites, was commonly articulated as a means for increasing
efficiency. The creation of common budget and payment mecha-
2 Collectively, the system of networks develop and implement both therapeutic
and prevention clinical trials. In terms of approval processes, therapeutic
protocols are submitted to the clinical science review committee
(CSRC) and are usually reviewed earlier in their development. Prevention
protocols are submitted to the prevention science review committee
(PSRC) and are typically further along in their development. In addition,
there are differences between therapeutic and prevention protocols regarding
study product registration and acquisition, accrual targets and rates, and
projected study length. These differences are often magnified at CRSs
where both types are implemented.