Case Study: Accelerating development in global COPD trials

Summary
Patient recruitment, extensive equipment requirements, and consistent data quality were major challenges for a program of global Phase II and Phase III trials addressing Chronic Obstructive Pulmonary Disease (COPD). Despite these challenges, PAREXEL achieved recruitment goals, database lock, and study completion substantially ahead of schedule, and the overall project finished 10 percent under budget. PAREXEL’s comprehensive range of services for these studies included trial management, clinical logistics, and integrated eClinical technologies.

Disease overview
According to the World Health Organization, an estimated 210 million people worldwide have COPD, and more than 3 million
died of the condition in 2005. By 2020, COPD is projected to become the world’s third-leading cause of death.

Key challenges and solutions

• Patient recruitment – At the time the studies were initiated, there were more than 200 other COPD studies underway that were competing for sites and patients. To avoid recruitment delays, PAREXEL applied a variety of pre-screening techniques, such as extending the qualification  visit process to roughly two times the number of sites planned, and planning for an additional 25% back up sites. All site initiation visits in a given country were conducted within 30 days of the first site initiation visit. As a result, recruitment for all of the studies was completed well ahead of schedule.
• Equipment requirements – Every study site needed a wide variety of equipment for these trials – including a spirometer for lung-function testing, ECG equipment, and electronic patient diaries – as well as extensive study material. PAREXEL coordinated the logistics of bringing this equipment together from numerous sources, then packaged it into a single, convenient shipment for each site. The time saved using this approach was calculated to be  approximately 2 weeks per site. Because all of the equipment arrived at one time, technical implementation could be accomplished with a single visit – accelerating the start-up process significantly and reducing transportation costs.
• Ensuring consistent study endpoints – Spirometry results played a critical role in these studies. Because the consistency of data from spirometry testing is highly dependent on the quality of the equipment and the skill of the operator, PAREXEL provided the equipment for every site, implemented an extensive training program for site personnel, and developed detailed testing procedures to ensure consistent, high-quality results throughout the studies.
• Effective communications to support continuous improvement – Achieving cost efficiencies across multiple studies requires on-going communication between the sponsor, the sites and the service provider to exchange best practices and implement adaptive improvements based on experience. PAREXEL initiated a formal communications program between project leaders, functional leaders and CRAs during these trials to identify successful recruiting approaches, re-use and adapt study documents, and share lessons learned at each step of the process to support continuous improvement. PAREXEL also implemented a Corrective Action/Preventative Action program to identify potential issues at sites and proactively address them before they developed into major problems that would impact deadlines or study results.
• Real-time visibility for all performance and quality metrics – The use of integrated eClinical technology provided transparency across all data at the study, country, and site levels. The project team carefully reviewed the data on a daily basis, which helped identify needs in a timely manner. Recruitment trends were analyzed on a weekly basis ensuring on schedule delivery. A client interface was built in IMPACT™ to share real-time data with the sponsor-creating trust and confidence in the team’s performance.

Results
With its comprehensive global network of expertise, clinical resources, and technology within a single organization, PAREXEL was able to provide an integrated package of services for these studies that accelerated study start-up, reduced costs, improved data quality, and reduced risks for the sites and the sponsor. The benefits of this integrated approach are demonstrated by the cost and time efficiencies achieved throughout the study program. Despite strong competition for patients, recruitment was completed ahead of schedule for all three studies, including 2.5 months early for the Phase III trial. Data lock and study completion were also ahead of schedule for all of the studies, with the Phase III trial completed more than 3 months early. Based on the study performance, the sponsor was able to submit regulatory filings months ahead of schedule.