Sunday, 24 September 2023

India can re-shape hybrid clinical trials

01 October 2020 | Opinion

There has been an overarching transition towards better economic value propositions, with the need for improved growth productivity and cost-efficiency within this industry

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The Asia-Pacific region is fast emerging as one of the significant regions for clinical trials, with a study by Global Data providing vital insights. The estimated number of clinical trial sites set up by biotechnology companies in the Asia-Pacific region has increased by an average of 40% every year, compared with 11% in the rest of the world. 

The global clinical trial management system market has been fueled by the demand for innovative drug products, increased occurrences of chronic diseases, and an increase in the aging population. However, within this industry, there has been an overarching transition towards better economic value propositions, with the need for improved growth productivity and cost-efficiency.


Clinical Research Market in Asia:

A Frost and Sullivan report suggests that Asia is growing in significance in the medicine market. In 2018, the Global biopharma industry's R&D expenditure was estimated at $167 billion, with only 27% of this spent on CROs. Forward-looking estimates suggest that by 2022, Asia alone could account for 20% of the Global CRO market.


Trends in Clinical Trial Management in Asia

Asia accounts for 54% of the world’s urban population. By 2050, India is expected to add 415 million urban dwellers, with China adding 215 million. With lower government support and per capita spend on healthcare, participation in clinical trials is seen as an opportunity to avail innovative therapies. 

Vast infrastructure, expertise, and facilities for conducting clinical trials are some other factors that promote clinical trials in this region. Moreover, disease conditions like diabetes, infectious diseases, lung conditions, and carcinoma have a higher prevalence in certain Asian countries, allowing for a more extensive study population. For example, over 120,000 patients and over 25,000 healthy volunteers were enrolled for various clinical trials. Infectious diseases have overtaken other therapeutics areas as companies are shifting their current focus to developing treatments to battle the COVID-19 pandemic.

Researchers from Asian countries contribute significantly to cited papers, highlighting their global expertise and extensive knowledge. India has a large pool of English speakers, focusing on higher education and research, giving it the impetus to produce smart research talent.

According to the International property rights index, there is also a significant shift towards safeguarding intellectual property and patent rights in the Asia Pacific region, with countries like New Zealand and Singapore featuring in the top 20% of countries. India and China also focus on diligent regulations, featuring in the 3rd quintile, ahead of some of the European countries.


Challenges in the Asian markets

There are inherent challenges in Asian markets like cultural and language differences, requiring translations of consent forms into local dialects. Understanding the regional languages and the needs of local populations will help in better managing clinical trials, signifying the importance of partnering with local clinical research organizations.


Future of Clinical Trials post Pandemic

COVID-19 has tempered the growth of the clinical research market across the globe, but projection offer hope, with a climb to nearly $64 billion in 2024, from $43.03 billion in 2019.

An interesting trend that has paved the way for risk mitigation in managing clinical trials during COVID-19 is increased dependency on digital and technology-driven solutions. It has been shown that 57% of interactions with patients and nearly 80% of interactions between clinical research organizations and sponsors were carried out remotely during the pandemic.

Some of the digital solutions include remote patient monitoring, telemedicine, and the use of artificial intelligence (AI) driven near real-time data monitoring, like OneClinical, to carry out faster data-driven interventions.  Wearables help patients monitor their health and connect with their doctor, while the devices also act as alarms alerting doctors about an impending health outcome.

Deloitte’s 2020 Global Life Sciences Sector Outlook indicates that AI market in drug discovery is expected to grow from US$159.8 million (2018) to US$2.9 billion in 2025. Technology-driven hybrid trials are critical factors expected to drive the contract research organization's future.  

Countries like India that are well-known for their expertise in IT and Bioinformatics will help in re-shaping hybrid clinical trials. Further, India accounts for 20% of the Global Generics industry and is the second most popular destination for clinical trials in the world. India is poised for another exciting phase ahead with a pulse on the need for virtual solutions in the new normal and clinical research expertise.


Dr Ayaaz Hussain Khan, Global Head Generics, Navitas Life Sciences, a TAKE Solutions Enterprise, India


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