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Global Clinical Trial : Challenges and Solutiions
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Clinical research has proven to be a boon for mankind with the consistent introduction of better and innovative drugs, diagnostic procedures and medical devices. A number of options are available today for many disorders which were considered to be incurable in the past. Unmet medical needs, downstream health cost, cost to individual country, sustenance of the pharmaceutical industry and patent expiry are some of the important factors driving the commercial organization for new drug development. However the process is not easy and fraught with risk and dangers. Time taken to develop a drug and the cost involved in it are the two most important factors encouraging the pharmaceutical and medical device companies to carry out clinical trials in the developing countries where there is scope of faster recruitment of trial subjects and cost attractiveness. This lead to the introduction of the term emerging market for clinical trials consisting of the countries like India, China, Brazil etc. which are found to be hugely successful markets. Thus the trend off shoring and outsourcing of clinical trials surfaced in 2002 and has been on a rise since then with evolution of large number of contract research organizations in such countries.
Even though this trend has been beneficial for the sponsors of the new innovations as well as the emerging hubs of clinical trials but there are a number of challenging aspects which has come into the light. We are provided with the opportunity in this knowledge paper to elaborate some of the most evident of the challenges of global clinical trials from each of the stake holder’s point of view and as relevant for India. We have also suggested solutions and recommendations with respect to the challenges which can help India to become the most optimal clinical trial zone among its adversaries.
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