Bringing A Digital Revolution In Indian Clinical Trials - ACRI India

1. Bringing A Digital Revolution In Indian Clinical Trials India has the second largest population and the largest disease burden in the world. In fact, India makes for almost 1/5th of the global disease burden. Because of such a huge number, India is looking for a digital revolution in clinical trials to know more about the challenges in clinical trials in India. Clinical trials have evolved over a long time; and there have been randomized clinical trials since the 20th century. Over the years, a lot of new therapies for diseases have gone through rigorous clinical trials. The way in which we conduct clinical trials and plan them, has gone through a significant evolution. Just like everything else is moving towards digital platforms, technology has been brought into clinical trials too. Virtual trials have been brought in, in which patients are sending data sitting in their homes, which is being collected from digital devices. Moreover, earlier, it used to take 12-15 years to develop a single drug. But today, the development cycle has shortened to an average of around 8-10 years. Also, there is rigorous testing happening all over. In the late 70s and 80s, there were certain companies doing randomized clinical trials. Then, in the 90s, the number of trials increased, and clinical trials went to becoming almost globalized in India. India was a part of the Global Drug Development since the late 80s and early 90s. The rules for clinical trials in India began in 1988 with the Schedule Drugs and Cosmetics Act. Before 2005, there was a phase lag in India, which prevented us from participating in the Phase 3 study. But, slowly and steadily, things improved and access of drugs to the patient became

2. easier. The Indian Society for Clinical Research (ISCR) was formed in June 2005, which came together to further the cause of good ethical clinical research so that the suffering of patients could be alleviated. And, by the time 2010 arrived, we saw a good increase in the number of clinical trials being done in India. We had almost 500 clinical trials registered in our country in the year 2010. Today, we have 40 clinical research organizations with 600 members from the industry and physician fraternity performing in our country. In 2013, the ISCR played a very important role to make the rules and policies of clinical trials more balanced. The rules were becoming more balanced from 2015 onwards, which were protecting the rights, safety, and well-being of patients. In 2017, we had almost 100 global clinical trials being approved in India, which was the beginning of things becoming steady and returning to India. Today, things are improving at a rapid rate. Clinical trials have helped us search for newer therapies and newer treatments for our patients. And, further, we wish to promote global drug development and bring a digital revolution in clinical trials in the near future. To help with such improvement, you need to lend a helping hand to your country. And for this, you can take up a course of diploma in clinical research Bangalore from a reputed institution like Avigna Clinicla Research Institute.