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nance structure to manage necessary
clinical and data exchange standards.
Each studied case has established a Data
Committee (or some derivative of it) as a
committee with its organization. Typically,
this group is responsible for the approach
to collecting data (e.g. primary or secondary), the use of collected data (e.g. research
and publications), and being active in the
development of clinical terminology and
data exchange standards. This group is
a multidisciplinary team (i.e. clinical and
technical expertise) that can be highly
influential in key standards and information governance decisions for the clinical
Success Strategy #7: Successful clinical data registries leverage advanced
technologies to improve the data governance processes.
The healthcare industry has seen a rapid
progression innovation due to advanced
computer and information technologies.
Technology companies, such as Amazon
and Google, have demonstrated the value
of using advanced technologies to create
an improved and customized user experience. CDRs are now adopting many of the
same data mining and analytics technologies to improve the data collection, storage, analysis and research experiences of
its users. Registries have been faced with
the complexities associated with building
a flexible and scalable technology infrastructure that secures patient data, while
allowing researchers to conduct highly
sophisticated data analyses. Each studied
registry has embraced the value of modern
information technologies from other industries to resolve technical challenges.
The data collected from each case support-
ed the literature and its description of the
technology challenges. Study participants
described their methods to managing vari-
ous informatics challenges, including: data
collection; data quality and validation;
data storage; multi-site data aggrega-
tion; lack of system interoperability and
the absence of clinical and data exchange
standards. The informatics challenges,
however, are not considered the barrier to
success for registry administrators. Each
felt that these challenges were a nuisance
but building a sustainable business model
was the most significant. They felt the
technology would improve with continued
advancements in data extraction, auditing,
storage and analytics tools. However, they
felt a weak business model could bring
demise to the registry.
In summary, there was tremendous
value in studying the multiple clinical data
registries across the country. Each organization was different but the cross-case
analysis captured the broader lessons and
strategies from each registry. It is important
for practitioners to recognize that each registry was established with a specific purpose and its evolution was directly influenced by the internal and external variables
that exist for any organization, including:
culture, politics, governance structure,
funding, therapeutic focus and technologic
Christopher Boone is a Vice President at Avalere
Health LLC in Washington, D.C, where he advises
healthcare clients on the use of clinical research
informatics and health IT policy. Boone has a BS in
Management Information Systems, MS in Healthcare
Administration and a PhD in Public Affairs.