Collecting the right late-phase data to support marketplace success

Late-phase studies (Phases IIIb and IV) constitute a rapidly expanding segment of the clinical research environment as the biopharmaceutical marketplace undergoes dramatic changes.  Regulatory agencies around the world are requiring additional data about the long-term safety and side effects of new products when they are used by larger numbers of patients in real-world settings.  Healthcare providers – and those who pay for healthcare – are demanding clinical evidence that new therapies provide better outcomes or greater value than existing standards of care.  To meet those growing data requirements, biopharmaceutical companies need a wider range of product and safety information that is not available from most Phase III trials.   

A typical late-phase study presents challenges beyond those experienced by researchers conducting earlier-stage trials.  One of most significant differences between Phase I-III and Phase IIIb/IV trials is the need to enroll substantially larger numbers of patients for the late-phase studies to produce the required breadth of data.  While a Phase III trial might include as few as 1,500  patients and less than 100 sites, a Phase IV safety or marketing study could encompass 5,000 or more patients at hundreds of sites.  In addition, late-phase or registry studies can run for five years or more, compared with 12-18 months for many Phase III trials.

Given the size and scope of most late-phase studies, greater efficiency in logistics, recruitment, site operations, and information processing is absolutely essential to control costs and handle the huge volume of data.  PAREXEL has extensive experience in Phase IIIb/IV studies across multiple therapeutic areas and trial sites around the world, including more than 220 Phase IV studies enrolling more than 330,000 patients around the world in just the last three years.  Equally important, our comprehensive suite of eClinical technologies ensure that we can manage these large trials efficiently and cost-effectively.

Our Phase IIIb/IV experience encompasses all types of peri-approval and post-marketing studies, including:

• On-going pharmacovigilance studies
• Risk management
• Comparative effectiveness research
• Observational (non-intervention) studies
• Health economics studies
• Patient registries
• Health-related quality of life studies
• Pharmacoepidemiology
• Expanded access programs