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International Clinical Trials

Patients Are a Virtue

Considering whether less haste in the short-term might actually improve speed-to-market, Mike Macnamee of LCG Bioscience urges the incorporation of patient studies into early stage clinical research

Although it is clear that there are many benefits of using patients in the early stages of clinical trials, it is also evident from recent discussions between sponsors and researchers that the use of patients before Phase II is still very limited. One of the reasons for this is that patient studies can be more time consuming to conduct, and this is an industry driven by speed. Additionally, while volunteer trials are well understood and the outcomes easily interpreted, patient trials are a new departure and generate a wealth of data that can create uncertainty in interpretation for both sponsor and regulatory authorities.

STOPPING EARLY STAGE TRIALS

One of the most effective ways in which pharmaceutical companies can hope to improve the efficiency of their development programmes is to terminate any project that is destined to fail as soon as possible. However, it is difficult in traditional drug development to distinguish winners from losers. And although it is late stage failures that cause the most angst for drug developers, there could be just as many promising compounds with useful indications that are dropped at the early stages because there is insufficient evidence of biological activity to justify the risk versus benefit ratio of their progression through the regulatory process.


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Dr Mike Macnamee is Chief Executive of LCG Bioscience, a provider of exploratory clinical research in volunteers and patient populations to the biotech and pharma industry. A graduate from Edinburgh in 1979 with a BSc in Psychology, he then gained an MSc in Pharmacology at London University, before returning to Edinburgh to complete his doctorate in Neuropharmacology (1984) at the Rosalin Institute. Mike founded LCG in 1993 and went on to create the Research Medicine Group for Serono. He has extensive experience in the development of both biological and chemical compounds targeting debilitating disease and has worked extensively across disciplines and cultures internationally. He led LCG to full independence through a successful MBO in 2005.
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Dr Mike Macnamee
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