Year : 2017 | Volume
: 8 | Issue : 1 | Page : 1-
Suneela Milind Thatte
President – Indian Society for Clinical Research, Mumbai, Maharashtra, India
Suneela Milind Thatte
B-204, Sadguru Co-operative Housing Society-II, Behind Wageshwari Temple, Gen. A. K. Vaidya Marg, Goregaon East, Mumbai - 400 063, Maharashtra
|How to cite this article:|
Thatte SM. President's Message.Perspect Clin Res 2017;8:1-1
|How to cite this URL:|
Thatte SM. President's Message. Perspect Clin Res [serial online] 2017 [cited 2017 Apr 25 ];8:1-1
Available from: http://www.picronline.org/text.asp?2017/8/1/1/198554
As we roll out this special issue of PICR, we as Clinical Research Professionals in India are standing at a very interesting juncture. We have witnessed, over the past 4 years, many significant developments on the regulatory front. While we have had our short-term challenges, today, we can proudly claim to be part of the process, whereby regulations were refined in favor of all stakeholders – Innovators, Investigators, Ethics Committees, and most importantly – Patients. We, at ISCR, have refined our focus areas to be part of this process and add value and this is reflected in our vision statement - “To promote a compelling scientific disposition and widespread awareness of clinical research for the advancement of health care.”
When I look back over the past 4 years, it is a proud moment for me to see how ISCR has supported various facets of clinical research. We have strived to ensure that the clinical research professionals, media, and investigators have all understood the new regulatory requirements and how they augment patient safety and data integrity. We have worked with many Ethics Committees and investigators to support them in creating processes that would help them comply with regulations as well as ethical codes governing clinical research. We have taken lead in creating patient awareness tools such as educational films, media write-ups, and patient FAQs – all in line with our “Patient First” principle.
This is certainly not the time, however, to rest on our achievements. As clinical research is entering the new growth phase in India, we are going to be watched by our global colleagues for quality and consistency. We will be expected to perform above the average and we need to do that so that India becomes a natural choice for global drug development and patients in India will be benefitted. Second, we all know about the escalating cost of drug development. Various estimates have put the cost of developing a new drug anywhere between USD 2.5 and USD 5 billion. According to the Tufts Centre for the study of Drug Development, the cost to develop and secure marketing approval for a new drug has increased by 145% between 2003 and 2013. This has necessitated faster, better informed decisions, thereby highlighting the need for innovation in drug development. This innovation is happening in the form of newer study designs, use of data and technology, predictive analysis as well as newer concepts such as risk-based monitoring. This offers enormous opportunity for technology-savvy countries such as India, and can prove to be a great skill-building opportunity if leveraged properly. Given that these innovations will make drug development faster, leaner, and cost effective, patients in India stand to benefit in a significant manner. We are the second most populous country in the world with the highest disease burden. We are labeled with unfortunate titles such as “Diabetes capital of the world.” We still have to worry about our basic health-care needs and we are genetically and socioeconomically distinct from rest of the world. Given these challenges, what we as a country need is a drug development agendum of its own – fueled by local innovation that meets our unique health-care needs. To us, this presents as a great opportunity and stimulus to take our deliverables and expertise to the next level.
I am confident that ISCR will continue to play a significant role and contribute to data-driven and efficient drug development.