Health Outcomes and Epidemiology

PPD provides expertise for a broad range of health outcomes studies that examine the clinical, economic and quality-of-life outcomes of pharmacotherapy and medical device technologies. Health outcomes research expands upon the FDA-mandated efficacy and safety endpoints to provide the reader a broader perspective of the outcomes experienced by a patient. Health outcomes combines a number of fields of study, including medicine, epidemiology, statistics, economics and psychometrics.

Our health outcomes research team offers expertise in each of these fields, both from an academic training perspective and a practical research background. The health outcomes team conducts high-quality research to support publication in high-impact journals, beginning with early development strategic assessments through launch and post-launch activities.

Process Expertise and Guidance

Clinical, behavioral, humanistic and economic endpoints can be measured at various points throughout the drug development process. Our health outcomes staff provides expertise in all these areas and can assist clients in successfully progressing through the process:

• Early in development, clients may be interested in documenting the epidemiology and cost burden of a particular disease state
• As a compound moves forward to Phase II-III, behavioral, humanistic and economic endpoints may be incorporated into registration trials
• Concurrently, economic models may be created to quantify the economic benefit of the new therapy
• Once a compound is launched, a variety of research services may be utilized, including registries, Phase IIIb-IV comparative studies and claims analyses

Partnership for Results

When you partner with our health outcomes team, you receive a consistent set of deliverables, including:

• Protocol or program description
• Statistical analysis plan
• Written database and tables, listings, figures, specifications
• Draft and final tables, listings, figures
• Draft and final study report
• Strategic use of findings to support submission for reimbursement