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International Clinical Trials

Strategic Planning

The pharmaceutical industry is experiencing tough times, facing both economic and regulatory pressures, with increasing demands for improved safety data and comparative efficacy studies, as well as late-stage pipeline failures and non-approvals by US and EU regulatory agencies. However, pharma has a wide variety of R&D strategies at its disposal to develop drug candidates faster and more efficiently. These can be implemented in isolation, but work more effectively in combination so as to optimise the linical trial process and increase the chance of clinical, and ultimately commercial, success. However, without efficient management and communication, the speed to market of a novel drug is likely to suffer.

CURRENT PROBLEMS WITH PHARMA R&D

In the increasingly competitive and cost-conscious pharmaceutical environment, it is important that pharma companies develop their pipeline products as quickly and cheaply as possible, while ensuring that they receive marketing approval as well as authorisation from the relevant reimbursement agencies. Failure to do so can have a significant economic impact and lead to company restructuring in order to balance the financial loss of drugs failing to reach the market (1).

During 2008, the number of drugs in Phase I clinical development was on the rise, but at the same time clinical trial success rates and the approval rate for new molecular entities (NMEs) were comparably low. In 2007, the FDA approved only 18 new drugs, the lowest number in 24 years (2). The number approved in 2008 was little better at 24 new approvals (3).


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Alistair Sinclair is a Senior Analyst in the Strategic Intelligence team at Datamonitor. After joining in 2003, he worked for three years in the Central Nervous System Healthcare team, producing a number of market analysis reports, focusing particularly on psychiatry drug markets. Alistair moved to the Strategic Intelligence team in 2006, and has since produced reports on a wide variety of strategic issues including lifecycle management, corporate strategies, pricing and reimbursement, sales and marketing, R&D and the emerging markets. Alistair holds a BSc from the University of Edinburgh in Medical Microbiology, and an MSc from UCL and KCMC University, Tanzania. He has also worked at the Health Protection Agency, and has published a number of papers from his research. Email: asinclair@datamonitor.com

 

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