Investigating Clinical Trial Costs: Comparative analysis of trial cost components in key geographies

Introduction

Pharmaceutical and biopharmaceutical companies are currently confronted by a variety of complex issues affecting their operational efficiency and profitability. However, firms in the industry have recognized the opportunities and advantages that can be accessed by conducting clinical trials in the emerging markets.

Scope of this research

• Explanation of the background to the clinical trials markets in the emerging geographic regions.
• Details of the key cost components to be considered when preparing a budget for a clinical trial.
• Comparison between the key regulatory authorities and rules governing the undertaking of medical studies in developed and emerging markets.
• Analysis of the specific issues affecting the clinical trials process in emerging economies.
• Assessment of costs in the mature and the emerging clinical trial markets.

Research and analysis highlights

Issues concerning the costs associated with drug development have been identified as: escalating costs associated with clinical trials, the global increase in the number of studies conducted, longer R&D development times and increased attrition rates during research.

The fees paid to clinical trial investigators are dependent on a variety of factors, including the therapeutic area, the study's location, the phase of the trial, the number of patient visits by the investigator, the type and number of procedures conducted, the affiliation and eminence of the investigator and the duration of the trial.

Traditionally, local hospital pathology departments were used to provide laboratory safety data for clinical trials. In the early 1990s, the concept of the central laboratory was developed and implemented by laboratories delivering services to major pharmaceutical companies.

Key reasons to purchase this research

• Discover the major elements involved in designing and planning a medical study.
• Understand the varied roles played by different regulators in clinical trials.
• Explore the principal issues affecting the development of drugs.
• Assess the cost components for each of the major steps in the clinical trial process.
• Compare the fees charged to authorize a study in different regions.