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Innovations
and Trends in Clinical Trials, 2007
Microdosing
(Phase 0 Trials), Adaptive Trials, Phase IV Trials
and the Role of Information Technology
Overview
Driven
by technological and scientific advances, the clinical
trials industry has clear potential for strong growth.
This trend is complemented by the development of
new trial designs, with a view to rationalizing
and accelerating the drug discovery process by identifying
failures at an earlier stage. This report provides
detailed information regarding new developments
in the field of clinical trials as well as an assessment
of the impact these new technologies and designs
are having and will have on the pharmaceutical and
biotech industries.
Key
Findings
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Overall,
a number of trends are set to influence the field
of clinical trials. Phase 0 (human microdosing)
will become more common and more desirable, while
Phase I is likely to morph into a shorter testing
stage.
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Similarly,
seamless designs are the future of the combined
Phase II and III, cutting development times and
associated costs. The latter change would advance
the trend already observed in the field, with
many trials designed to test efficacy and safety
concurrently.
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Additionally,
post-marketing studies will gain importance as
patient, ethical and regulatory demands increase,
as much as the methods for toxicology testing
becomes more sophisticated. Such changes will
be supported by the use of existing and new technology.
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Human
microdosing clearly holds significant promise
as an analytical tool. In the coming years, as
research methods and technology involved in Phase
0 trials become more sophisticated, human microdosing
may be applied to a number of drugs that could
potentially be administered consecutively.
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Looking
further into the future, the trend of combining
adaptive designs with the goals of Phase IIb and
Phase III trials is likely to become the norm.
This type of trial, described as seamless adaptive,
will aim to become even more time-efficient, although
it may carry higher risks for first-in-class drugs.
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Phase
IV trials will continue to grow at an estimated
annual rate of over 20 percent. According to some
estimates, companies are likely to invest over
US$12 billion in this area in the course of 2007.
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Phase
IV trials will be increasingly used to expand
a drugs indications, its geographical reach,
as well as to disseminate information to medical
professionals, regulatory authorities and patients
alike.
Key
Features of This Report
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Analysis
of emerging clinical trial innovations, including
microdosing (Phase 0 trials), adaptive trials,
Phase IV clinical trials and information technology
trends in the sector.
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Integrated
discussion and analysis of regulatory activities
affecting new clinical trial designs and information
technology in clinical trials.
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A discussion of the future trends in the clinical
trials marketplace, shaped by medical and technological
advances as well as demographic and epidemiological
changes and industry needs.
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Profiles
of the leading companies active in microdosing
(Phase 0), adaptive trials, Phase IV trials and
information technology.
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Overview
of the clinical trials industry.
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In-depth
information and analysis regarding different types
and phases of clinical trials, including their
brief history.
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