Clinical trials and foreign affairs: Key points to consider when conducting studies abroad
Pharmaceutical companies often resort to other countries such as Africa, Asia, Latin America and Eastern Europe in attempt to further enhance revenue growth and to carry out clinical trials that are, by comparison, far more cost-effective.A large amount of specialists in the pharmaceutical industry have recognised this trend and are making use of this cost effective service offered abroad due to the large amount willing volunteers and also due to the international increase in demand for healthcare products.
Clinical trials are fairly inexpensive to conduct in these countries.
Due to the vast increase in research, sales and production in these regions, CRO’s (clinical research organisations), biotech and pharmaceutical companies are now being challenged with ethical business problems. Some countries are faced with corruption issues around clinical trials due to the need for logistical and institutional capacities, trials being approved are taken for granted or are increasingly difficult to attain which leads to back-handing or bribes for securing the necessary approval to conduct a specific clinical trial.
The Corruptions Perceptions Index, examined by Transparency International (a not-for-profit organisation based in Berlin), gives a basis for which the threat of corruption can be estimated.The index is planned to gauge countries based on the views of state analysts and business executives.China was ranked seventy-second, Brazil at eightieth and India ranked eighty-fifth out of a total of 180 countries, where the country ranked the lowest would be considered to be the least corrupt.
Pharmaceutical and Biotechnology organisations need to consider this before looking to outsource their studies in other countries. They need to be fully aware of the ethical violations that there CRO partners may encounter. If these organisations are ignorant towards this, the clinical trial may in turn be jeopardised or the trial outcome report could be made invalid if the CRO carrying out the study have breeched any ethics violations that may be in place. This could be detrimental for the organisation’s reputation, and could hinder any business in that country for the future.
Nicky Hargreaves has over 24 years in R&D, manufacturing, quality and regulatory affairs.”Trusted UK based Clinical Research organisations or clinical pharmacology companies who provide professional clinical trials UK (providing the statistical analysis, medical writing and the clinical research) that assists with the development of new drug entities are known to be the top resource.” Says Nicky; who is a microbiologist by training and has managed projects in numerous divisions, including pharmaceutical, medicinal, OTC, oral healthcare and animal healthcare.
* Before taking any medical advise you should consult your doctor. *