Abstract
Overview
The clinical trials industry has clear potential for strong growth in the
future, driven by technological and scientific advances. 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
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.
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.
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.
Other Highlights
- 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.
- 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.
- 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. Phase IV trials will be
increasingly used to expand a drug' s indications, its geographical reach, as
well as to disseminate information to medical professionals, regulatory
authorities and patients alike.
Key Features of This Report
- Analysis of emerging clinical trial innovations, including microdosing
(Phase 0 trials), adaptive trials, Phase IV clinical trials and information
technology trends in the sector
- Integrated discussion and analysis of regulatory activities affecting new
clinical trial designs and information technology in clinical trials
- 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
- Profiles of the leading companies active in microdosing (Phase 0),
adaptive trials, Phase IV trials and information technology
- Overview of the clinical trials industry
- In-depth information and analysis regarding different types and phases of
clinical trials, including their brief history
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