Innovations and Trends in Clinical Trials: Microdosing (Phase 0 Trials), Adaptive Trials, Phase IV Trials and the Role of Information Technology

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.

• 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