Oncology Clinical Trials in Emerging Regions

Oncology remains the main therapeutic area which most pharmaceutical companies are most actively pursuing and oncology clinical trials in emerging regions continue to grow. Large patient populations mean that sponsors are able to target and design clinical trials to treat specific cancer related diseases. It is estimated that of the approximately 12 million new cancer cases in the world each year over 60% will occur in emerging regions.

It is questionable now whether India and China can still be referred to as ‘emerging regions’ and countries such as Brazil and Korea, with faster approval times and in the case of Korea, government assisted programmes designed to facilitate easy access into the country are playing an ever increasing role.

Despite this the number of oncology clinical trials failing continues to increase. Recent studies show that 34% of phase three candidates fail at phase three over the past seven years. The FDA is considering tightening the accelerated approval standards and the Oncologic Drugs Advisory Committee has advised sponsors to conduct randomised trials rather than single arm studies and also that there should be more extensive post marketing studies to establish clinical benefit.

So how will this impact on the role of clinical trials in emerging regions such as Latin America, Central and Eastern Europe, the Middle East and Africa and Asia Pacific?

The 4th Oncology Clinical Trials in Emerging Regions will assess the current ever changing operational, regulatory and logistical challenges being faced when conducting oncology clinical trials in emerging regions as well as looking at the future role that emerging regions will play and which of the lesser known countries will continue grow in importance.

Some of the subjects under discussion will include –

• The role of emerging regions against the backdrop of ever tightening FDA regulations
• Small pharma: fighting for attention. Examples of oncology clinical trials being conducted in lesser recognised countries
• The CROs role in conducting oncology clinical trials in emerging regions
• Randomised trials v Single arm studies in oncology clinical trials
• Overall 34% of Phase 3 clinical trials fail – can emerging markets reduce the failure rate or are they contributing towards it?
• Overcoming the challenges and variations of localised regulatory procedures
• Logistical challenges of conducting clinical trials in emerging regions – what are the main regional challenges and variations
• Patient recruitment and retention in emerging countries – challenging the frontiers
• Conducting post marketing studies of oncology clinical trials in emerging regions
• Oncology clinical trials in China – a case study of large clinical trials and the challenges faced
• The role of electronic data capture to accelerate the completion of clinical trials