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Why Conduct Clinical Trials in Central and Eastern Europe?

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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By Dr Jean-Pierre Tassignon, Executive Vice-President at PSI Pharma Support Intl

Dr Jean-Pierre Tassingnon is Executive Vice-President of PSI Pharma Support International AG in Switzerland, a position he has held for eight years. He is trained in Medicine and Business Administration, and has diplomas in Pharmaceutical and Industrial Medicine. Jean-Pierre began his career as a Corporate Counsellor for Industrial Medicine and Toxicology at Solvay in 1974, where he stayed for 14 years. In 1982 he became International Medical Director at Solvay and then joined Covance in 1988 as Executive Vice President in Europe for Corning-Besselaar, where he remained until 1992. Jean-Pierre is on the Board of Examiners and lectures post graduates in pharmaceutical medicine at Universitй Libre de Bruxelles.

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Dr Jean-Pierre Tassingnon
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