The Clinical Trials

Report Highlights

• The number of clinical trials in the US reached 2,519 in 2002.
• They will increase at an average annual growth rate (AAGR) of 12.3%.
• By 2007, $26.555 billion will be spent on clinical trials.
• R&D budgets will increase at an AAGR of at least 10%.

INTRODUCTION

Mapping the human genome has opened exciting new possibilities for the development of new medications. Indeed, the field of genomics is accelerating the discovery of new and novel treatments. In parallel, advances in biochemical techniques are enhancing the process of biotechnological research. As discovery technologies more quickly determine greater numbers of targets, increasing numbers of compounds will be reaching the clinical trial phase of development.

Clinical trials test a product or device to determine such factors as safety, efficacy and adverse reactions in a human population. They are an integral part of any biotechnology or biopharmaceutical company’s R&D effort. In fact, determining the number of drugs in clinical trials is key to assessing the longterm health and growth possibilities of these companies, and the amount of money being spent on R&D.

Of the four types of clinical trials (prevention, quality of life, screening and treatment), BCC focuses its report on treatment trials. This is because they comprise the vast majority of clinical trials that test new treatments, devices, combinations of existing medications, and new approaches to surgery or radiation.

This report provides readers with a comprehensive understanding of the clinical trials process and its role in the research and development of new medicines. It thoroughly studies clinical trials, i.e., phases of clinical trials, U.S. government regulations, international regulations, costs of clinical trials, technologies, contract research organizations (CROs) and other factors. The analysis forecasts trends and clinical trial costs through 2007. It also looks at the factors that bring drugs/devices as far as the clinical trial, and asks the questions: What percentage of new chemical entities/proposals makes it to clinical trial? Who benefits from clinical trials, medically and financially?

SCOPE OF STUDY

This report focuses on:

• Influences on R&D of drugs and biologics
• Technologies
• Current and future trends in clinical trial research with five-year forecasts
• New technologies impacting the costs and processes of clinical trials
• Major product pipelines by physiological system and company
• Regulatory issues.

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.

ANALYST CREDENTIALS

Kecia Brown holds a Master of Public Health degree with a concentration in epidemiology and biostatistics. She has participated in medical research and in public health projects at universities and public health agencies. Ms. Brown has also worked in the biotechnology industry as a medical writer.