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European Pharmaceutical Contractor

Global Acceptability of Clinical Data - Fact or Fiction?

One of the challenges of running clinical trials is obtaining adequate representation from all the groups in society that may receive a potential new medicine. As a result, regulators may be placed in a difficult position regarding the approval of new drugs where the majority of the dossier comprises of foreign clinical data.

The pharmaceutical industry is also in a difficult position as trials grow in size and become more expensive to run. With companies devoting up to 40 per cent of their R&D expenditure to clinical evaluation, companies cannot afford to run trials that will account for every foreign patient group that might receive a potential drug.

This has led to worries that patients in some countries will not be able to gain access to certain drugs because regulatory authorities will be reluctant to approve them. Japan is often cited as an example in such cases. For example, of the 149 drugs approved in the US between 1992 and 1996, 51 per cent were not available to patients in Japan by 2000 (1).


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By Carly Anderson and Faiz Kermani of CMR International

Carly Anderson joined CMR International in April 1999. She has been involved in a number of projects including those in the areas of regulations, pharmaceutical investment and output and marketed medicines.

She graduated from King's College, London with a molecular biology degree and a special interest in genetics.

Dr Faiz Kermani joined CMR International as a Research Associate in October 1999 from Imperial College, London, where he was carrying out postdoctoral research in immunology.

Previously, he obtained a PhD in Immunopharmacology from St. Thomas' Hospital, London, and a First Class Honours Degree in Pharmacology with Toxicology from King's College, London. Faiz has also worked as a Research Analyst for Danish health care company, Informedica a/s, writing on European and North American health care issues.


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Carly Anderson
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Dr Faiz Kermani
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