spacer
home > ict > winter 2008 > patients are a virtue
PUBLICATIONS
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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
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.
spacer
Dr Mike Macnamee
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Turkish Cargo keeps growing in the first quarter of 2019

Maintaining its accomplished operations from Ataturk and Istanbul airports as "Dual Hub", the global brand of Turkish Cargo continued its strong growth momentum during the first quarter of the year despite the shrinkage of the global air cargo sector.
More info >>

White Papers

Another Successful Visit Against the Odds

Medical Research Network (MRN) Limited

Our dedicated team of nurses, couriers and project managers deliver, come rain or shine. Making sure a Clinical Trial visit can go ahead in the home can be a complex process, and last month bad weather nearly stopped play on an important Home Trial Support visit. Thanks to the commitment and dedication from the entire team it went ahead against the odds.
More info >>

 
Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement