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. 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.
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, supervised by Transparency International (a not-for-profit organisation based in Berlin), gives a foundation for which the hazzard of corruption can be estimated.The index is planned to gauge countries based on the views of state analysts and business executives.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. This industry should fully know the about the ethical violations that Clinical Research Organisations may come across 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 who provide professional clinical trials (providing the statistical analysis,
medical writing and
data management) 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.
