Clinical Trial Outsourcing Perceptions
In answering this request, a system of measuring perception was identified and used. One of the most precise ways of measuring perception is conducting surveys asking stakeholders how they feel about the subject. For this research, three major groups were identified. Their perception was then measured by relying on their reactions to clinical trials in India and similar countries. Stakeholders measured are the FDA, pharmaceutical companies and academics. Perception of the American public is not included in this response primarily because clinical trials have not become an issue of extensive public debate, although the position of academic liberals may offer insights into their likely perception.
The FDA have been working with pharmaceutical companies to come up with procedures that will bring greater clarity and transparency to clinical trials in India. When the story broke in 2011 of a lawsuit challenging the regulatory guidelines governing clinical trials in India, the FDA pushed for better frameworks leading to new protocols being set up in 2014. In 2016, concerns were again raised, not just by the FDA but by the WHO over data quality/manipulated data. A year later, those concerns were clarified and confidence was gradually restored as shown in this report. Therefore, it can be assumed that the FDA has a positive perception towards clinical trials in India and would like to keep working there. This is further emphasized by the fact that India has the highest number of drug manufacturing plants outside the United States.
These companies have the least concerns over the out-sourcing of clinical trials to BRIC countries prominent among which is India. Their worry stems more from additional costs that accrue when the quality of data is questioned or litigation arises due to not maintaining the highest ethical standards. The reasons for their favorable disposition is that India offers lower operational costs, timeliness in registering patients and quicker approvals — about six to seven months. Not all pharmaceutical companies are in favor of having trials in India however, some who are liberal minded prefer other options as shown in the next subhead.
Liberals and academics have a negative perception of clinical trials in India. They worry about fidelity of data used in the trials especially because of reports which catalog deaths arising from not following ethical standards while registering patients for trials or taking advantage of people's economic situations. One of the biggest reasons they give is the replacement of the Declaration of Helsinki with Good Clinical Practice (GCP) by the FDA as shown in the use of placebos. They also point out the level of experience of participating doctors, exploitation of vulnerable volunteers, and a lack of trained clinical monitors. They would prefer such trials in Russia and Eastern Europe. These countries also offer lower operational costs with more reliable data. Pharmaceutical companies that share this perception choose to keep their trials in the United States or select some other alternative.
The general perception of stakeholders over clinical trials in BRIC countries is positive. There have been concerns, especially from liberals and academics, questioning how trustworthy and reliable the overall outcomes of the trials are. But, the FDA and pharmaceutical companies have pushed for better regulations and policy frameworks from India and these have helped douse tensions.