Clinical trials and foreign affairs: Key points to consider when conducting studies abroad
Clinical Trials that are less expensive can be found being conducted in countries like Latin America, China and India; these countries strive to increase the market growth and industry revenue. Many Bio Technology and Pharmaceutical Companies now outsource clinical research to these emerging countries. The attraction of these emerging markets is acknowledged by many in the industry; where an expanding middle class allows for more healthcare spending and where there are a number of willing and treatment-naïve volunteers available to recruit.
The conduct of Clinical Trials has become cost effective 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. Due to a lack in logistical and institutional capacity, many of these countries are faced with situations which lead to government representatives and business leaders accepting bribes or becoming involved in other corrupt acts with the aim of securing approval to conduct a certain clinical trial, or acquiring the materials to conduct these studies.
The Corruptions Perceptions Index, supervised by Transparency International (a not-for-profit organisation based in Berlin), gives a foundation for which the threat of corruption can be estimated.The index is intended to rate countries based on the views of business execs and state analysts.India was ranked 85th , China 72nd and Brazil 18th out 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 pharmacology companies who provide professional clinical trials (providing the statistical analysis, Clinical Data Management 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. *