by Saransh Chaudhary
In the rapidly evolving landscape of pharmaceutical research, India finds itself on the cusp of a transformation that promises to significantly elevate its contributions to global clinical trials. A key component of this evolution are Investigator-Initiated Studies (IIS), which offer a fresh perspective on drug discovery and development, beyond the conventional clinical trials conducted by pharmaceutical giants. Let’s examine how.India is in the middle of a remarkable shift in clinical research dynamics, poised to emerge as a global hub for clinical trials in years to come. This ascent is underpinned by a confluence of compelling factors: a diverse patient population, a wealth of experienced investigators, cost-efficient research infrastructure and forward-thinking regulatory reforms. With these foundational pillars in place, the country’s prominence in clinical research is plausible. No wonder, pharma majors like AstraZeneca, Novartis, Eli Lilly, Pfizer and Johnson & Johnson are the top sponsors of clinical trials in India.
While a recent study, “Clinical trial opportunities in India”, released by the USA India Chamber of Commerce and PwC in May has observed that India is emerging as a favourable clinical trial destination, the report further suggests that the country has the potential to increase its global clinical trials by five times in coming years. Furthermore, India has witnessed a twofold increase in the number of investigators between 2015 and 2020. Considering the large and diverse patient pool, streamlined regulatory processes and a highly skilled workforce, the country offers a conducive environment for efficient and cost-effective clinical trials.
But there is still a long way to go. As of now, India contributes only 3 per cent to global clinical trial participation, but accounts for more than 15 per cent of the global prevalence of high-incidence diseases like respiratory infections, cardiovascular disorders, diabetes and cervical cancer, the PwC report further points out. This glaring mismatch presents huge opportunities to researchers to fill this gap and harness India’s immense potential as the next clinical trial destination by enrolling more subjects for clinical trials. High disease prevalence in India ensures swift patient enrolment for trials across a spectrum of therapeutic domains.
This is precisely where the inventive concept of Investigator-Initiated Studies (IIS) comes into play. Transcending the traditional clinical trials conducted by pharmaceutical behemoths, IIS are led by independent researchers and academic sponsors associated with institutions, who are rewriting the rules of drug development, exploring novel applications for existing drugs, venturing into uncharted therapeutic territories and raising the bar for patient care standards. By tapping these possibilities, pharmaceutical researchers can advance their drug development timelines, make their research more productive and develop innovative solutions to fulfil unmet medical needs, particularly in critical care segments, to put India on the path of clinical trial leadership.
Instrumental in achieving medical breakthroughs for pressing health problems and generating valuable data on the safety and efficacy of drugs in real-world settings beyond what is typically tested in clinical trials, IIS form the core of these efforts towards new drug development. Having immense potential to improve patient care and ignite new ideas for further disease-related research, IIS assume more importance in the current scenario marked by a significant increase in burden of critical diseases, than ever before. Furthermore, these studies can help identify new uses for existing drugs and explore new indications for drugs that are currently under development.
However, the practical difficulties faced by investigators in securing funding for their research is a major stumbling block. Recognising this limitation, the Venus Medicine Research Centre (VMRC), the R&D wing of research-driven pharmaceutical firm Venus Remedies Ltd, has come forward to assist qualified investigators in conducting research by extending grants and material support through its Venus Investigator-Initiated Studies Hub. Other research-oriented pharmaceutical organisations should take a cue from such initiatives and follow suit to address the funding challenges in the way of drug research.
As India prepares itself to take its rightful place as a leader in global clinical trials, we eagerly anticipate that the collaborative efforts of all the stakeholders involved will help actualise the country’s potential. Together, we will witness the transformative impact of India’s rise in the field of clinical research, fostering a healthier future for the entire humanity.
(The writer is President, Global Critical Care, Venus Remedies Ltd and CEO, Venus Medicine Research Centre)
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