CMR International thomsonreuters.com

The Global Clinical Performance Metrics Program provides participating companies with independent, reliable and up-to-date clinical benchmarks that track the trends in clinical activity. These benchmarks include pipeline progression, trial location, patient numbers and cycle times.

The Program is designed to answer the following key questions:

• In which areas of clinical development should my company focus to improve clinical productivity?
• What are the most important characteristics that influence study cycle times? What is the impact of therapeutic area, active substance type, target novelty, number of sites per study, etc?
• Are there any common themes or characteristics emerging for post approval clinical studies?
• Do different approaches to global clinical development yield different returns?
• Are my company’s timelines by therapeutic area competitive with the rest of the industry?
• How does my company’s performance in patient enrolment compare to others in the same therapeutic area?
• Are there any consistently good performers in all aspects of clinical development? If so, what distinguishes the best performers?

Each participating company will receive a suite of company-specific outputs including benchmarking reports and access to analytical online tools.

Clinical Study Performance Survey

A Regional, Country and Site Perspective

The Clinical Study Performance Survey provides participating companies with an authoritative source of regional, country and site-level data on key metrics associated with the execution of clinical studies.

The Survey will seek to answer the following key productivity questions:

• How long is it taking the industry to start up a clinical study in each country?
• Where are the bottlenecks typically to be found?
• How well are countries performing in actually enrolling patients when compared with the numbers that were planned to be enrolled, and converting enrolled patients to treated patients?
• Within each country what is the variability by site in the number of patients planned versus the number of patients enrolled, the number of patients enrolled versus the number of patients treated, and the enrolment duration?
• What is the influence of therapeutic area on the above key metrics?
• How does my company’s performance compare with the industry in study start up times, patient enrolment times, and patients planned, enrolled and treated?
• On the site level, how does my company compare with the industry in patient yield and in enrolment rate?
• Which countries have high concentrations of high-performing sites and which countries have high concentrations of low-performing sites?
• How well is my company selecting sites in the different countries?
• How many countries are companies entering to recruit the patients required for their clinical studies?
• What proportion of these countries deliver 80% of the patients?

Each participating company will receive the exclusive Clinical Study Insights Briefing that provides a broad perspective on clinical productivity as well as an assessment of the impact of globalization on clinical productivity. They can also choose to receive the Clinical Study Performance Data Sourcebook, a collection of analyses into issues of current importance to participants.