About Author: Mr Naz Haji is the Senior Vice President and Managing Director of QuintilesIMS. Based out of Bangalore office, Naz is responsible for providing vision, strategic business and technology direction, and operational capabilities to support the company’s growth across Asia. Bringing 25 years of experience in international business systems, technology process re-engineering and consulting, Naz has been a key leader within multiple industries including pharmaceuticals, manufacturing, utilities and various other sectors.
Clinical research is highly regulated and complex and not easy to understand. It is governed by international and local guidelines with a strong focus on patient safety and confidentiality. We, as an industry, have not invested enough in creating greater awareness and education about clinical research amongst the public at large. In addition, in the recent past we have seen instances of media misreporting and sensationalism which have only served to misrepresent the industry further.
An example of this is in the reporting of deaths in a clinical trial. Many reports do not make a distinction between the death of a patient in a clinical trial and death of a patient due to a clinical trial, and mislead the public into believing that clinical trials are the cause for a large number of deaths. The death of a patient in a clinical trial could be due to various reasons, including the natural progression of a disease the patient suffers from, other underlying diseases the patient has or something totally unrelated like an accident. All deaths of a patient in a clinical trial, whether related or not, have to be reported to regulatory authorities and the distinction needs to be made when reporting deaths in a clinical trial.
“Patients who are an important beneficiary in the clinical research process were hesitant to come out and tell their stories. We are seeing that beginning to change now”
Similarly, the industry has done little to highlight the high quality of clinical research being done in India. The narrative of clinical trials in India seems to be driven by a few instances of transgression rather than the many instances of good quality work being done across the country.
Given the challenges in the regulatory environment we had in India in the recent past, patients who are an important beneficiary in the clinical research process were hesitant to come out and tell their stories. We are seeing that beginning to change now with a few patients coming forward to speak of their positive experience in clinical trials. This will go a long way in allaying fear and misconceptions about clinical research amongst the public at large.
Overall, advancements in technology are playing an increasingly important role in our understanding and management of healthcare and disease. These advancements are also impacting the way clinical trials are being conducted and managed with technology driving end-to-end customer value, incorporating design, execution, engagement and commercialization within the drug development process. The industry has seen a lot of innovation in the application of technology and will continue to do so. India is well positioned to take advantage of these trends given the rich technical expertise that resides in this country.
Outlook is bright!
I believe that the worst is now behind us. We have had a very challenging few years but in the last couple of years, several corrections have been made in regulations to ensure it is more balanced and science-oriented, while being patient-centric. Our biggest challenge now is to take that message globally and restore the confidence of global stakeholders in doing clinical research in India. We have definitely seen an improvement in regulatory approval timelines and a more collaborative and consultative approach by the Indian regulators which is good for all stakeholders. We are hopeful that this forward momentum will continue.
“I believe that the worst is now behind us. We have had a very challenging few years but in the last couple of years, several corrections have been made in regulations”
We have seen a lot of streamlining in the regulatory environment. We also see the regulators seek feedback periodically on the new guidelines and procedures which indicates that they are very open to incorporating stakeholder feedback and making their processes even more robust. What we now need is an investment in proper governance to ensure that the guidelines are implemented and governed well.
On approval timelines, while they have reduced significantly from a few years ago, if we want to be competitively positioned with other countries, we need to bring down approval timeline approvals further from the current six to seven months to three months. This would then be another compelling reason for sponsors to conduct clinical trials in India.
Hopefully, there will be greater understanding and appreciation of the role and value of clinical research. I am optimistic that Make in India for clinical research will be a reality with more innovation and R&D taking place in our country.