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Optimising eClinical
The Convergence of Healthcare and Clinical Research Standards
a report by
Pierre-Yves Lastic, PhD
Senior Director, Standards Management & Data Privacy, sanofi aventis R&D
Most individuals involved in the collection, validation, coding, transfer, administrative, financial and clinical information between independent
analysis, reporting and archiving of data from clinical trials are generally computer systems on a variety of hardware and software environments.
aware of the existence of the standards developed by the Clinical Data HL7 has also developed specifications for documents, leading the way
Interchange Standards Consortium (CDISC).
1
In fact, most people towards the implementation of electronic medical records. Above all,
working in clinical research across the world use these standards on a during these 20 years of continuous improvement, HL7 has put in place
daily basis, or at least specifications derived from or inspired by them. It a standards development and maintenance methodology that can cope
is fair to say that the majority of these people are unaware of Health Level with the extremely complex processes that are the norm in healthcare.
Seven (HL7)
2
standards. On the other hand, software developers working
on hospital information systems routinely implement HL7 specifications, CDISC is only half as old as HL7. It started as a volunteer group within the
but know CDISC only from hearsay. However, there is a growing Drug Information Association (DIA) in 1997 and was incorporated in
community of healthcare and clinical research professionals working with 1999. Most of the original CDISC members worked as statisticians, data
a foot in each world. If you are not yet among them, here are a few managers or programmers in biopharmaceutical companies, contract
answers to frequently asked questions. research organisations or software providers, yet they faced a number of
similar business problems:
Where Do HL7 and CDISC Come From?
HL7 is one of several standards-developing organisations (SDOs) • agreeing about data exchange formats with development partners,
accredited by the American National Standards Institute for the clinical research organisations and central laboratories, then spending
healthcare arena, and has just celebrated its 20th birthday. It was born at considerable amounts of time and resources to check and clean the
a time when information systems used in healthcare were not linked with exchanged data;
each other. This meant that patients admitted to a hospital filled in paper
forms that clerks entered into the administration system. The patient • redefining internal data formats and database organisation with each
received a printout and took it to another department, where staff would merger or acquisition;
perform the examinations and write these results on other paper forms
that would eventually be entered in a different computer. A similar • customising software systems to accommodate different data
process occurred at the pharmacy and involved yet another form, which models; and
would be attached to all the forms from the hospital; the whole paper
stack would then be filed to the insurance company for reimbursement. • transforming and reorganising clinical study data from different
sources to be able to prepare integrated summaries of safety
Similar systems still operate in many countries. Nevertheless, growing and efficacy.
healthcare costs have driven a huge optimisation effort and, as bytes are
easier to move than physical forms, electronic messages are progressively On the other side of the fence, the US Food and Drug Administration
replacing paper-carrying patients. HL7 plays an important role in this (FDA) was confronted with the need to analyse data from thousands of
process as it has defined sets of standardised messages to carry bits of clinical trials, all formatted differently.
These different business cases led CDISC to develop several models: an
Pierre-Yves Lastic, PhD, is Senior Director of Standards
XML model called the operational data model (ODM) dealing with the
Management & Data Privacy at sanofi-aventis R&D. After
working for several years as an Assistant Professor at the
acquisition, validation, transfer and archival of clinical data; the LAB
University of Bayreuth, he moved to the pharmaceutical
model specifically for the exchange of data from central laboratories; a
industry where he spent 17 years in different management
positions in the field of clinical research, leading clinical data
submission data model (SDM; now called the submission data tabulation
management, biostatistics, clinical operations and model, SDTM) defining the format and organisation of raw data
information management, first with Ciba-Geigy
submitted to the FDA for review and analysis; and an analysis data model
(Switzerland), then with Synthélabo, Sanofi-Synthélabo and
sanofi-aventis (France). Dr Lastic is a member of the Board
(ADaM) documenting the analysis process.
of Directors of the Clinical Data Interchange Standards
Consortium (CDISC) and of the International Pharmaceutical
Privacy Consortium (IPPC). He studied biology, computer
The Different Models
sciences and languages in France and Germany and holds a A partnership between HL7 and CDISC makes a lot of sense. HL7 can
PhD in biology from Bayreuth University, Germany.
provide proven methodology and know-how from the healthcare side,
while CDISC can contribute expertise in the clinical research domain.
14 © TOUCH BRIEFINGS 2007
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