Oncology clinical trials in India

Abstract

Cancer is a challenging field of research in which the big Pharma and the global governments spend billions of dollars to conduct research programs, focussing on finding a cure for this deadly disease. Oncology research is no wonder one of the largest therapeutic area in terms of clinical trial activity. Reputed national and international journals have already declared India as the most preferred destination with about 49% of global trials moving to India. The union government’s amendment to Schedule Y of the Drugs and Cosmetics Act and formulation of progressive policies has helped the growth of clinical research in the country, especially in the field of oncology. During the last decade, oncology research has undergone progressive globalization. India has a proven record of delivering medical data that meets international regulatory standards.

Introduction

Cancer is a challenging field of research in which the big Pharma and the global governments spend billions of dollars to conduct research programs, focussing on finding a cure for this deadly disease. According to WHO report, cancer diagnosed patients have been steadily rising and will soon touch the 12 million mark and by 2030, new cancer cases could increase to 27 million with up to 17 million deaths annually.

Oncology research is no wonder one of the largest therapeutic area in terms of clinical trial activity. The availability of treatment naïve patient pool, trained and experienced oncologists and presence of state-of-the art facilities for oncology trials in India makes it as a destination for most of the global pharmaceutical and biotechnology companies. Reputed national and international journals have already declared India as the most preferred destination with about increasing number global clinical trials enrolling in India.

Clinical Trial Outsourcing

To bring a new molecule to market, on an average it costs anywhere between $ 100 and $ 800 million and it takes 7-10 years to complete. According to industry estimates, conducting Phase I and II trials in India are comparatively cheaper than in other countries.

The union government’s amendment to Schedule Y of the Drugs and Cosmetics Act and formulation of progressive policies has helped the growth of clinical research in the country, especially in the field of oncology.

During the last decade, oncology research has undergone progressive globalization. It was estimated that an average of one million new cases of cancer are reported every year from India. Big Pharma in recent years is focussing on the conduct of oncology research in India. The country offers 700000 speciality sites, 221 medical colleges with trained and experienced English speaking medical staff and personal and state-of-an-art facilities and infrastructure for the conduct of oncology clinical trials in the country. The increase in medical tourism to India from the West supports the fact that India has state-of-an-art medical facilities and experienced medical staff.

Reasons for Clinical Trial Outsourcing to India

The various reasons for outsourcing clinical trials to India from the West:

• High rate of subject recruitment (nearly 7 times than in US)
• Treatment naïve patient pool
• Occurrence of large number of cancer cases
• Huge unmet medical need
• Presence of high productive clinical trial sites
• Availability of skilful and trained investigators
• Increased standard of care
• Availability of cancer registries and databases
• Availability of stipulate regulations and regulatory bodies

India has implemented product patents since 2005. This has widened the Indian market to invite companies to import clinical trial technology to enhance the drug development process in India. According to the latest studies based on the Indian Council of Medical Research (ICMR) cancer atlas, cancer is the second commonest non-communicable disease in India after ischemic heart disease. Several companies have started drug discovery and development process for novel cancer therapeutics making India to stand at the crossroads of innovation on oncology research.

As India offers a large no. of clinical trial subjects for global clinical trials, sponsors and global pharma include India to their outsourcing destinations for oncology research. India has 16 % of global population but 20 % of the global disease burden of which the majority are cancer patients. There are approximately 3 million patients with cancer in India; with about 1 million new cases detected every year. India is a mixture of public and private health care providers. The insurance coverage is low compared to the West; hence a huge unmet medical need exists in India. The India’s large population, high disease burden and unmet medical need collectively results in providing large number of potential, willing participants in oncology clinical trials from India.

Indian regulations are stable, stringent, progressive and evolving to meet international standards. The regulations mandate the conduct of clinical trial only after obtaining the written consent from the participating subjects, which balances the industry need and to ensure the subjects protection. There are potential benefits to Indian patients in these cancer trials. Through phase II studies there is an opportunity for patients to get access to novel cancer medications free of cost. These medications are likely to have very little toxicity and a reasonable chance of efficacy.

Most of the Indian clinical institutions and investigative sites have their own, well developed ethics committees (EC) that comply with the ICH Good Clinical Practice and applicable local regulations. About 13 successful NDA submissions and 14 FDA inspections with no “Official Action Indicated” verdicts fall into India’s credit since 2005. Hence India has a proven record of delivering medical data meeting international regulatory standards.