India has successfully performed the first human clinical trial of gene therapy for ‘haemophilia A’ at the Christian Medical College – Vellore as was informed by Union Science and Technology Minister Jitendra Singh on Wednesday. Singh mentioned that the trials involved deployment of a novel technology by using a lentiviral vector to express a FVIII transgene in the patient’s own haematopoietic stem cell that will then express FVIII from specific differentiated blood cells. Many similar feats have been achieved by Indian organizations in clinical research and trials because of which the country has become a globally renowned hotspot for such initiatives.
"India boasts a robust infrastructure, a cadre of seasoned investigators, and cost-effectiveness, collectively rendering it an appealing choice for such endeavors”, mentioned Dr. Mrinalini Darswal, PhD scholar at Harvard University at the recent Bio-Pharma summit held in Boston.
India has seen significant developments in the clinical research and trials sector over the past decade and has experienced close to 18 percent growth in phase two and phase three trials. Experts have stated that the improving healthcare infrastructure and private hospital networks have considerably contributed to this growth. The developing start-up ecosystem around the healthcare and bio-pharma sector also needs a mention in this regard. With numerous developments taking place in this sector it is intriguing to know how they are making way for better clinical trials in the country.
Most of the top pharmaceutical MNCs in the world are currently looking to make India as the base of their clinical research and trials operations. Developments in healthcare infrastructure over the past decade have made the approach for clinical trials in India much easier and accessible compared to other countries. In order to facilitate the process of clinical trials, 10 modifications have also been brought to the Drugs and Cosmetics Act of 1940. Many other industry leaders in the global pharmaceutical sector have also pointed out that slowly and steadily, the scenario is changing in India and they are looking a number of opportunities in the clinical research and trials sector that are going to undergo development in the coming few years. India is currently having an overall clinical trial participation of three per cent but contributes to more than 15 per cent of the global burden of most high prevalent diseases (e.g., respiratory infections, cardiovascular, diabetes, and cervical cancer) that is presenting an untapped potential for therapeutic interventions.
"Hospital chains and hospital networks are actually also clearly modernizing. Seventy per cent of the patients are in private hospital networks. Private hospital networks are now diversifying into tier two, and tier three cities, into tertiary networks as well. That gives you broad-based access to patients. So this is all the things that are going on that makes India pretty attractive for clinical trials, “mentioned Badhri Srinivasan, Global Clinical Operations Head, Novartis at the recent Bio-pharma and Healthcare Summit organized by the USA Indian Chamber of Commerce.
It is the participation and engagement of patients in clinical trial processes that is crucial for the approvals and validations for all the therapeutic interventions. In this regard, it is important to mention that the traditional methods to engage patients in clinical trials are often not enough to bring in people from the remote locations of the country who belong to the underserved communities. Most of the clinical trial centers are concentrated in the cities and there are several challenges and barriers faced by patients in their way to engage in the process. These challenges include inability to travel long distances, high costs of transportation and unavailability of caregivers who can stay with patients. There are few other logistical constraints as well.
In this aspect, Startups in the bio-pharma sector are steadily emerging as leaders in patient-centricity, and creating decentralised solutions for clinical trial that are surpassing geographic barriers and empowering patients to engage themselves in the research. Remote monitoring by means of wearable technologies, direct-to-patient shipment and arrangement of virtual conversations between patients and caregivers and being performed many healthcare start-ups that are accelerating patient engagement and access to clinical research and trials.
“In the dynamic landscape of healthcare, where clinical trials represent the cornerstone of medical progress, startups have emerged as key drivers of change. The clinical trials market in is expected to expand at a compound annual growth rate (CAGR) of 8.2 per cent reaching $3.88 billion by 2030”, mentioned Dr Sanish Davis, President, Indian Society for Clinical Research to the media.
To give an example, an Indian start-up that focuses on patient centricity in clinical trials is Navia Life Care. The company offers digital health solutions aimed at improving patient engagement and adherence to treatment, including clinical trial participation.
Organizations are currently prioritizing patient-centricity, embracing and leveraging decentralized trial methodologies, breaking down hurdles to facilitate patient participation and democratising people’s access to clinical research in the country. One segment in which companies have shown tremendous prowess is in leveraging modern technologies like artificial intelligence (AI) and machine learning (ML) in order to streamline various aspects of clinical trials.
Right from optimization of patient recruitment by means of predictive analytics and all the way to automation of data collection and analysis, AI/ML solutions are offering unchartered opportunities for enhancing efficiency, reducing costs, and improving quality of data. By harnessing the power of these cutting-edge technologies, many startups and big corporations are at the forefront of transforming the clinical trial landscape, enabling faster and more accurate decision-making while minimizing the chance of human error and bias.
An Indian startup working on predictive analytics in clinical trials is THB (Trialogue Health Biotech Pvt Ltd). THB specializes in providing AI-powered predictive analytics solutions for clinical trial optimization. Their platform utilizes data analytics to streamline trial processes, improve patient recruitment, enhance trial site selection, and optimize various aspects of clinical trial management.
There are few other developments in terms of changing regulatory landscape, patient access to research and patient engagement that are further taking this sector ahead of the global competitors in this domain. Influenced by the above mentioned factors, the clinical trials and research sector of India is poised for multidimensional growth in the years to come.
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