Innovations and Trends in Clinical Trials
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
Table of Contents
- Table of Contents
- 1Methodology and Executive Summary
- 1.1Report Objectives
- 1.2Report Methodology
- 1.3Executive Summary
- 1.3.1Microdosing
- 1.3.2Adaptive Design
- 1.3.3Phase IV Post Marketing Trials
- 1.3.4Information Technology
- 1.3.5Clinical Trials Outlook
- 2Clinical Trials – Background
- 2.1Introduction to Clinical Trials
- 2.2Clinical Trials Marketplace
- 2.3Types of Clinical Trials
- 2.4Phases of Clinical Trials
- 2.5Brief History of Clinical Trials
- 2.6Need for Innovation in the Pharmaceutical Industry
- 2.7Need for Maximization of Drug Development
- 2.8Major Limitations of Present Clinical Trial Designs
- 2.8.1Cost
- 2.8.2Inflexibility
- 2.8.3Time
- 2.8.4Use of Animals
- 2.8.5Early Trial Failures
- 2.8.6Pharmacogenomics
- 3Clinical Trials – Overview of New Developments
- 3.1Present Situation
- 3.2Regulatory Environment
- 3.3Need for Changes
- 3.4Likely Future Trends in Clinical Trials
- 3.5Partnerships in the Realm of Clinical Trials
- 4Phase 0 Clinical Trials
- 4.1Overview
- 4.2Human Microdosing - Technology
- 4.2.1Accelerator Mass Spectometry (AMS)
- 4.2.1.1Key Study Details
- 4.2.2Positron Emission Tomography (PET)
- 4.2.2.1Key Study Details
- 4.2.3Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS)
- 4.2.4Liquid Scintillation Counting (LSC)
- 4.2.4.1Key Study Details
- 4.2.1Accelerator Mass Spectometry (AMS)
- 4.3Regulatory Issues
- 4.4Recent Changes in Regulatory Environment
- 4.5Microdosing Versus Conventional Clinical Trial Methods - Advantages and Disadvantages
- 4.6Microdosing and the Use of Animals
- 4.7Examples of Phase 0 Clinical Trials
- 4.7.1Neurocrine Biosciences
- 4.7.1.1Key Study Details
- 4.7.2Radiant Research
- 4.7.2.1Key Study Details
- 4.7.3Resverlogix
- 4.7.3.1Key Study Details
- 4.7.4Speedel Pharmaceuticals
- 4.7.4.1Key Study Details
- 4.7.5Tripep
- 4.7.5.1Key Study Details
- 4.7.6Vitalea Science
- 4.7.6.1Key Study Details
- 4.7.7Xceleron
- 4.7.7.1Key Study Details
- 4.7.1Neurocrine Biosciences
- 4.8Future of Phase 0 Clinical Trials
- 5Adaptive Trials
- 5.1Overview
- 5.2Forms of Adaptive Trials
- 5.2.1Scientifically Predetermined Outcome
- 5.2.2Continual Reassessment Method (CRM)
- 5.2.3Adaptive Randomization
- 5.2.4Group Sequential Trial
- 5.3Regulatory Issues
- 5.4Recent Examples of Adaptive Trials
- 5.5Adaptive Versus Controlled Clinical Trials – Advantages and Disadvantages
- 5.6Future of Adaptive Clinical Trials
- 5.7Adaptive Clinical Trials - Company Overviews
- 5.7.1Bristol-Myers Squibb (BMS)
- 5.7.2Eli Lilly
- 5.7.3Novartis
- 5.7.4Pfizer
- 5.7.5Tessella
- 5.7.6Wyeth
- 6Phase IV Clinical Trials
- 6.1Overview
- 6.2Regulatory Issues
- 6.2.1Completion of Promised Post-Marketing Studies
- 6.2.2Clinical Trials Registries
- 6.2.3Results Disclosure
- 6.3Examples of Comparative Phase IV Studies
- 6.3.1Strattera
- 6.3.2Magnex
- 6.3.3Avonex
- 6.4Examples of Indication Extension Phase IV Studies
- 6.4.1Remicade
- 6.4.2Velcade
- 6.4.3Humira
- 6.4.4Visicol
- 6.5Examples of Product Withdrawals Following Phase IV Studies
- 6.5.1Lipobay/Baycol
- 6.5.2Rezulin
- 6.5.3Vioxx
- 6.6Future of Phase IV Trials
- 7Information Technology in Clinical Trials
- 7.1Overview
- 7.2Regulatory Developments
- 7.3Benefits of Information Technology
- 7.4Examples of IT in Clinical Trials
- 7.5Electronic Data Capture (EDC)
- 7.5.1Market Value and Potential
- 7.5.2Main Benefits of EDC
- 7.5.3Key Therapeutic Areas for EDC Application
- 7.5.4Companies Using EDC
- 7.6Clinical Trials Management System (CTMS)
- 7.6.1Advantages and Disadvantages of CTMS
- 7.6.2Companies Developing CTMS
- 7.7Clinical Data Management System (CDMS)
- 7.7.1CDMS Subtypes
- 7.7.1.1Database Management System (DBMS)
- 7.7.1.2Case Report Form (CRF) Designs
- 7.7.1.3Data Entry Interface
- 7.7.1.4Reporting/Analysis
- 7.7.2Companies Involved in CDMS Design
- 7.7.1CDMS Subtypes
- 7.8Clinical Trials and the Internet
- 7.9Security, Confidentiality and Ethical Concerns
- 8Company Profiles
- 8.1Pharmaceutical Companies
- 8.1.1Bayer
- 8.1.2Bristol-Myers Squibb (BMS)
- 8.1.3Eli Lilly
- 8.1.4InKine Pharmaceuticals
- 8.1.5Johnson & Johnson (J&J)
- 8.1.6Merck & Co
- 8.1.7Novartis
- 8.1.8Pfizer
- 8.1.9Wyeth
- 8.2Biopharmaceutical Companies
- 8.2.1Biogen Idec
- 8.2.2Cambridge Antibody Technology (CAT)
- 8.2.3Millennium
- 8.2.4Neurocrine Biosciences
- 8.2.5Pharmaceutical Profiles
- 8.2.6Radiant Research
- 8.2.7Resverlogix Corporation
- 8.2.8Speedel Pharmaceuticals
- 8.2.9Tripep AB
- 8.2.10Vitalea Science
- 8.2.11Xceleron
- 8.3Medical Device Companies
- 8.3.1Asthmatx
- 8.4Pharmaceutical Software Companies
- 8.4.1DATATRAK
- 8.4.2etrials
- 8.4.3Phase Forward
- 8.4.4Tessella Support Services
- 8.1Pharmaceutical Companies
- Glossary of Terms
- Appendix : Regulatory Guidance
- Tables
- Table 2.1 Types of Phase I Trials
- Table 2.2 Phases of Clinical Trials
- Table 2.3 Total Expected Sample Sizes for Alternative Clinical Research Programs
- Table 2.4 Regulatory Agencies for Pharmaceutical Products in Major Global Markets
- Table 2.5 Areas of Animal Use
- Table 4.1 Advantages and Disadvantages of AMS
- Table 4.2 Advantages and Disadvantages of Human Microdosing
- Table 4.3 Benefits of Microdosing in Relation to Studies on Animals
- Table 4.4 Drugs Tested with Human Microdosing in the CREAM Trial
- Table 5.1 Advantages and Disadvantages of Adaptive Clinical Trials
- Table 7.1 IT in Clinical Trials
- Table 7.6 Examples of Applying IT to Improve Clinical Trials Performance
- Table 7.3 Improvement of Process and Increase of Business Value through the Adoption
- of e-Solutions
- Table 7.4 Technology Map for Clinical Trials
- Table 7.5 Benefits of IT in Clinical Trials
- Table 7.2 Reasons Cited for Not Adopting New Data Collection Methods
- Graphs
- Graph 2.1 Decreasing R&D Productivity
- Graph 2.2 R&D Costs and Research Productivity
- Graph 4.1 Semilogarithmic Plot of the Plasma Concentration/Time Profile of Midazolam
- Graph 7.1 Impact of Technology on Clinical Trials
- Graph 7.2 Cost Comparisons (in US$mn) of EDC Budgets of Four Clinical Trials with
- Corresponding Paper Model and EDC L2TTP
- Graph 7.3 Comparison of Efficiency of EDC versus Paper Data Collection
- Figures
- Figure 2.1 Overview of the Activities Involved in Modern Drug Discovery and Development
- Figure 2.2 Phases of Pre-clinical and Clinical Development
- Figure 5.1 Graphic Representation of Adaptive Trial Design
- Figure 5.2 Re-Analysis of Pravachol Pac Clinical Trial Using Bayesian Techniques
- Figure 7.1 Typical Systems That Can Be Integrated with CTMS
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