Trial Design and Scientific Leadership: How to Boost Patient Recruitment in Asia and Around the World

The expectations laid out in ambitious protocols and trial design can at times conflict with the operational realities of trial delivery. In today’s complex, high-cost, high-risk clinical trials environment, the development of complex protocols can present some operational challenges if unanticipated in the trial design, causing issues throughout delivery. These challenges can include less than desired patient recruitment metrics, delayed start-up times, less than perfect communication between investigator sites and the CRO/Sponsor, as well as regulatory complications, all of which result in greater expense for the sponsor.

In this live webinar, the speakers will discuss the importance of Scientific Leadership in the trial design process and integrating it throughout trial delivery. They will examine the challenges of trial design in the Asia-Pacific along with the region’s many opportunities for all phases of clinical studies.

Professor Perkovic will additionally use examples of George Clinical’s work and how George Clinical has implemented Scientific Leadership in some of its large, complex trials, from study design and throughout trial delivery. The examples will include:

• Case studies from some multi-country trials with global pharmaceutical companies investigating renal outcomes in diabetic kidney disease
• The largest trial ever conducted in severe acute renal failure, which recruited over 1,500 participants in 35 intensive care units
• A large-scale trial, recruiting 8,600 patients, developed in partnership with the Veterans Administration (USA) to provide definitive evidence for the effects of 2 commonly used agents upon the risk of patient harm following angiographic procedures
• The ongoing 45 And Up Study, a large-scale cohort study that recruited more than 250,000 New South Wales (Australia) residents aged 45 years and older (representing 10% of the population in that age bracket). The study will examine the complete disease pathway for people with diabetes and Chronic Kidney Disease (CKD)
• The SHARP study which evaluated whether lowering cholesterol in patients with kidney disease affected their risk of having a heart attack, stroke or death. It involved more than 9,000 patients with lower than normal kidney function (chronic kidney disease) in 380 hospitals across 18 countries around the world

Professor Perkovic will discuss:

• The role of Scientific Leadership in trial design and trial leadership
• The impact of Scientific Leadership when integrated with trial delivery
• Case studies where Scientific Leadership made a quantifiable, positive impact for the Sponsor, especially on patient recruitment and retention
• The benefits of designing and conducting large clinical trials in Asia

Speakers

Professor Vlado Perkovic, MBBS PhD FRACP FASN, Director, George Clinical Executive Director, The George Institute, Australia

Vlado Perkovic is Executive Director of The George Institute, Australia, Professor of Medicine at The University of Sydney, and a Staff Specialist in Nephrology at the Royal North Shore Hospital. His research focus is in clinical trials and epidemiology, in particular in preventing the progression of kidney disease and its complications. He leads several major international clinical trials, serves on the Steering Committees of several others, and has led the development of George Clinical, the global clinical trials arm of The George Institute. He has been involved in developing Australian and global guidelines in kidney disease, cardiovascular risk assessment and blood pressure management.

Vlado holds a Doctor of Philosophy from the University of Melbourne and completed his undergraduate training at The Royal Melbourne Hospital. He is a member of the National Health and Medical Research Council Principal Committee on Research Translation; is Chair of the International Society of Nephrology Action for Clinical Trials (ISN-ACT) group; and is a Fellow of the Royal Australasian College of Physicians and of the American Society of Nephrology.

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Emma Field, Project Manager, George Clinical, A division of The George Institute for Global Health

Emma Field is a Global Project Manager with George Clinical with an MSc in Clinical Research and over 10 years’ experience in the clinical trial industry. Emma has worked within small CRO’s and large pharmaceutical companies across phase I – III clinical designs. Roles include Data management, Senior Project Management and Operations Management, from initial design concept through to marketing authorisation submissions.

Within George Clinical, Emma leads a team of regional scientific managers within a robust infrastructure of operational support, who collectively manage and coordinate the global Scientific leadership of National Leaders within a large program of Phase III clinical trials. Emma’s role also includes the coordination of the Executive Steering Committee and all sub committees ensuring clear peer to peer communication pathways are established and maintained. Leveraging the framework of National Leaders and Scientific Committee members, coordinated centrally, allows the delivering the George Clinical Scientific model.

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