A COMPARISON OF BREAST CANCER CLINICAL TRIALS IN THE UNITED STATES VS INDIA: ANALYSIS OF REGULATORY REQUIREMENTS

Abstract

Breast cancer is the most common malignancy among females worldwide. Breast cancer rates are particularly rising in developing countries such as India. The changes in the prevalence of cancer risk factors are resulting in more and more patients are diagnosed with breast cancer in India. Although the incidence of breast cancer is lower in India in comparison to the United States (U.S.), mortality rates associated with breast cancer are higher in India. Breast cancer in India is often diagnosed at an advanced stage and a younger age in comparison to the U.S. Breast cancer clinical research involving human subjects aims to produce innovative treatments and procedures to combat the burden of breast cancer. Clinical research in breast cancer is growing in India due the rising incidence of and mortality rate from the disease. Globalization of clinical trials has become a trend for pharmaceutical companies as well as federal agencies. India was deemed one of the most attractive global destination sites for clinical trials until the incidence of unethical practice gained media attention nationally and internationally. Several incidents of unethical practice claiming altruistic motives were not the main focus, but rather profit was the concentration. The unethical practices involving Indian subjects tarnished the country’s attractiveness as a site for clinical trials, resulting in a decline of clinical research in 2010-2012. India has since amended Schedule Y, the requirement and guidelines for conducting clinical trials established under Drugs and Cosmetic Act 1945. The amendments were in effort to resolve issues regarding clinical research, with hopes to regain trust in clinical research processes. To better understand if the claims of unethical practice are a present-day issue, evaluating the process of clinical trials in India is necessary. Clinical research in breast cancer worldwide provides multiple efforts to advance treatment of breast cancer. Comparing breast cancer trials in India versus the U.S., a country known for having the most regulatory rules and processes, could open up the discussion of similarities and possible shortcomings through a literary review of regulatory framework, roles and responsibilities of sponsor and investigators, recruitment and enrollment trends, informed consent processes, and post market access of approved marketed breast cancer treatments.