Dr. Sanjay Gupta MD, COO, Asiatic Clinical Research talked about The Emerging Markets of Asia for Global Clinical Trials and more specifically about India’s competitive advantage on April 18, 2012 in Millbrae, CA. He began the talk with emphasizing that site selection process is an extremely critical aspect to ensure patient enrollment and retention, in India. Patient dropouts reflect on protocol and safety issues and adds to the cost. USFDA does not control sites but does look at the data very critically. About 80% of data comes from India. USFDA has office in India since last 5 years and works with Indian regulator, the DCGI (Drug Control General of India).
The obvious question is why India and there are several clear advantages in considering India. India has relatively young population with outstanding skills in medicinal chemistry, pharmacology, and toxicology, an established medical and clinical community with state of the art medical centers which are often equipped with state of the art, modern medical equipment. Given the large population base, there is also a huge patient pool that ensures speedier recruitment of patients. However cautioned Dr. Gupta, one must also bear in mind that it is always challenging to get very speedy recruitment, most cheaply, with excellent quality of data. But India’s large patient pool ensures availability of treatment naïve as well as treatment refractory patients. An additional often-cited reason to consider India is that the country’s English speaking system of education, minimizes major cultural challenges. Albeit, cultural challenges do exist and companies must prepare to deal with them. For instance, an Indian patient often puts complete and blind faith in the physician and the physician recommendation often matters more to them than being fully informed through reading material and informed consent forms. Also, given the interconnectedness of Indian culture, the family is an integral part of decision-making. Whether or not a patient should get enrolled in the study is more likely a family decision, rather than an individual one. Ease of communication however is greatly enhanced because of the common language. In India, most paperwork and drug labels do not have to be translated from English, minimizing effort and time and possibility of misunderstanding. Only the patient information and consent forms have to be translated into the native languages.
Besides the obvious advantages in terms of cost savings of 30% or more of clinical studies done in India, compared to the US, regulatory process is faster in India, compared to China and Latin America. In India, Ethics Committee would review the material while it is also going through the process of regulatory review. In China, there is sequential process of approval which can take up to 15 months compared to about 18 weeks, to get approval of the dossier, in India. There was an animated discussion of India’s refusal to allow first in man studies by foreign multinationals. The reasons for this could be political as well as entrenched community distrust of foreign multinationals.
Dr. Gupta proceeded to share specifics about Asiatic Clinical Research organization which has great internal resources, excellent network across healthcare providers in India, and an ability to offer a range of quality services at economical cost. He can be reached at email@example.com . Also questions can be addressed to their local liaison in the US to firstname.lastname@example.org . For more research, all India clinical trials are listed at the Government website http://www.ctri.in and India’s DCGI website is http://www.cdsco.nic.in . For soft skills (global inclusion, effective inter-cultural, and diversity) training to ease cultural challenges in India and leverage the experience, please contact Darshana Nadkarni at wd_darshana at hotmail.com. See last panel in the article http://bit.ly/HouFfD that discusses Medtronic as a case study for providing global inclusion training to the resources in India.