The Clinical Trials Business

Abstract

INTRODUCTION

This report is designed to provide readers with a comprehensive understanding of the clinical trials process and its role in the research and development of new medicines in the U.S. It will provide an overview of clinical trials, including phases of clinical trials, U.S. government regulations, international regulations, costs of clinical trials, technologies, contract research organizations (CROs), and other factors. This report will forecast trends and clinical trial costs through 2011.

Generally, clinical trials are performed on drugs that have undergone a long test period. What are some of the factors that are and will bring drugs/devices as far as the clinical trial? What percentage of new chemical entities/proposals makes it to clinical trial? Who benefits from clinical trials, medically and financially? These areas will be reviewed and analyzed in this report.

SCOPE OF STUDY

This report contains:

• An overview of clinical development phases, the regulatory issues involved and the factors influencing clinical trial costs
• An in-depth analysis of the U.S. market for clinical trials that reviews historical data, market trends, and forecasts through 2011
• Highlights for new and upcoming technologies and developments that could have an impact on the clinical trials business
• Profiles of the major players in the business.

METHODOLOGY

Information contained in this report includes data obtained from government agencies, corporate publications, industry trade publications and various news sources. Interviews were conducted with leaders from trade associations, universities, the Food and Drug Administration (FDA) and professional agencies. Further information was obtained through an extensive literature search. Forecasts were based on 10K filings, specific factors that could impact clinical trials, and conversations with industry insiders.

INFORMATION SOURCES

Information contained in this report includes data obtained from government agencies, corporate publications, industry trade publications and various news sources. Interviews were conducted with leaders from trade associations, universities, the Food and Drug Administration (FDA) and professional agencies. Further information was obtained through an extensive literature search and conference attendance. Forecasts were based on 10K filings, specific factors that could impact clinical trials, and conversations with industry insiders.