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European Pharmaceutical Contractor
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Clinical trials are both a major financial investment and a risk for pharmaceutical and biotechnology companies. The Boston Consulting Group estimated that when interest and drug failure costs are taken into consideration, the cost of developing a new drug could be as high as US$500 million (1). This cost is primarily driven by the increasingly stringent requirement for companies to satisfy relevant regulatory authorities that the drug being developed is both effective and safe for use in the patient populations for whom it is intended. Clinical trials undertaken to provide this reassurance can vary from single centre studies right up to the multi-centre, global studies with thousands of patients undergoing treatment for several years. This increased tendency for long-term global trials is driven by numerous aspects, including the following:
The need to enrol appropriately 'treatment-naive' patients in a heavily medicalised world
The need to push for subtle improvements over existing therapy
The need to encompass 'outcomes' issues and pharmacoeconomic aspects
The need to check for rare interactions and adverse events
The need to provide data involving populations/countries included in launch plans
The need to provide persuasive evidence to authorities no longer confined to purely medical assessment
The overall increased regulatory hurdles have resulted in a drug development time of 15 years being considered average - from the time of a new chemical entity's discovery in the laboratory to the eventual marketing approval and granting of a product licence (2).
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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MipTec, October 14 – 16, 2008, Switzerland
MipTec about to take off by joining forces between Life Sciences Week, ALL-SystemsX.ch-Day, & Jobvector.com
More info >> |
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