 deCODE
is applying its population approach and resources to make the clinical
development process a more efficient and sensitive means of evaluating
the therapeutic potential of new drugs. We have pioneered the concept
of the Information-rich Clinical TrialTM (IRCTTM),
integrating into the design, cohort selection, and results analysis of
clinical trials detailed data on a number of genetic and phenotypic
variables. By doing so, we can go beyond the standard trial structure
of recruiting participants according only to basic clinical diagnosis
and measuring outcome against static endpoints. The IRCT paradigm
enables us to use clinical development to determine not just whether
people respond to drugs, but also who responds best and why. We believe
this is a crucial means for better managing risk in the development
process, speeding drug development and lowering cost, and for
maximizing the patient benefit and market potential of new drugs.
The
key to the IRCT approach is our ability to combine clinical trials
conducted by Encode, our wholly-owned clinical trials subsidiary, with
our population data. Encode has enrolled over 3,000 patients in over 30
clinical trials. In an IRCT the trial cohort is enriched by
using population-based epidemiological data as well as data on genetic
markers, gene-expression patterns and serum biomarkers correlated with
a given disease. This enables deCODE's clinical team to select for a
trial patients who are susceptible to disease through the pathway
targeted by the drug and are thus likely to respond.
Because
of the much larger amount of information going into and coming out of
an IRCT, we can test therapeutics for major indications more quickly
and with significantly smaller cohorts than would normally be required.
The results of an IRCT can then be applied to understand and predict
the responsiveness of the patient population at large, information that
can be used in further clinical development or to bring the drug to
market.
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