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European Pharmaceutical Contractor
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How Toxic are Clinical Delays for the Industry?
With 80 per cent of clinical trials suffering delays of two to six months, entire programmes are being set back by one to four years. Delays in clinical R&D tend to cumulate from study to study, and those relating to studies on the critical path, by definition, have a negative impact on the whole development programme. Suppose there are six, 12 or 18 studies on the critical path of three different programmes and the average time lost per study is two months - the bare minimum.
The corresponding programmes will be delayed by 12, 24 and 36 months, respectively. At an opportunity cost of no less than US$500 million per year, clinical delays become lethally toxic to the pharmaceutical industry. To make matters worse, as the programme progresses, studies, which were not on the critical path in the original plan, may now become time-critical because of cumulative delays upstream.
Delays tend to cascade in clinical programmes. It is likely that the causes which hindered earlier studies, such as lack of patients, will persist from study to study. It is very difficult to ask teams downstream to compensate for the delays of teams upstream in the process. It is even tough to blame a team for delays in any single project because responsibilities are diffuse, and individuals will reject blame when responsibilities are collective. In addition, fear of blame is not a stimulating R&D environment. As a result, no-fault responsibility becomes the rule.
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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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