spacer
home > epc > winter 2003 > why conduct clinical trials in central and eastern europe?
PUBLICATIONS
European Pharmaceutical Contractor

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.


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
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.

spacer
Dr Jean-Pierre Tassingnon
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Registration Opens for Inaugural HPAPI USA Conference in October

The HPAPI global market is growing at an ever-increasing rate of CAGR at 8.6% that is projected to reach USD $31.56 Billion by 2025, with a significant segment market of HPAPI being oncology ADC which is at a CARG of a staggering 20%. The continual elevation of HPAPI potencies along with toxicity will further drive the needs for more cutting-edge containment solutions and best practices guidelines to ensure workers safety.
More info >>

White Papers

Running Better Trials Taking an Intelligent Monitoring Approach

Bioclinica

When it comes to implementing a risk-based monitoring program, it is not just about reducing monitoring visits and doing less Source Document Verification (SDV). It’s about bringing together your people, a solid process, and the right technology to run a better trial. Success with risk-based monitoring requires the ability to make sense of the thousands, if not millions, of data points captured by multiple disparate sources in a clinical trial. With the sheer volume of data generated on a daily basis comes complexity. How does one make sense of it all? Information overload burdens even the most experienced study teams who struggle to understand which data matters most and what it means.
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