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 Clinical research organisations are now innovating and working on customized approaches. There has been a wide scale technology adoption for digital informed consent, e-diary, digital biomarkers, e-health record management, and easy access to the availability of information on health and services, said Akshay Daftary, Director, SIRO Clinpharm, in an email interaction with Nandita Vijay. Excerpts:
How would you describe the current scene for clinical research in India, globally?
Over the past decade, there has been an increase in inflow of clinical research into India. Clinical trials in the Covid-19 era have seen rapid growth, especially in the past few months, with several vaccines and drugs related to Covid-19 entering various clinical trial phases. While it usually takes 8-9 years for drugs to reach the final stakeholders after the development process, the race for the vaccine in 2020 fast-tracked a lot of regulatory processes while also ensuring that the quality, safety, and efficacy of the trial were not compromised. The urgency of the situation has led to countries around the world going ahead with emergency approval of the vaccines. In some cases, including India, vaccines have been made available for the people during the Third Phase of clinical trials to mitigate the impact of the pandemic.
While India has faced challenges pertaining to its medical infrastructure, the country also came out as a leading player in experimentation, manufacturing and development of the vaccine. India has also made use of proactive intervention and strong regulatory guidelines to control the pandemic and minimize the damage during the first wave. In addition, the current global situation has strengthened India’s clinical research ecosystem to scale up the infrastructure to match the country’s demand. In India, with the scalability of the IT industry and its economic advantage, it is easier to facilitate new age clinical research. Through the use of artificial intelligence, an integrated workflow can be maintained which has improved the management of research for the trials. The most relatable function of AI (artificial intelligence) is the integration of clinical workflow to improve the management of research records. It has also widened the scope for real-time diagnosis of patients with accuracy in surgical data and produces. AI also contributes towards the speed and efficiency of clinical decisions.
In addition to the new drugs, clinical research plays an important role in bringing generics to the market. In times of rising healthcare costs, one cannot ignore the role of generics. Clinical outcome in the above category of products is vital to ensure the quality of the generics, an assurance that the generics drugs will behave in the same manner as the reference drug. SIRO caters to the requirement of difficult generics and follows on biologics and to ensure that it can meet all client requirements, it has put in place a strategic alliance with the help of Azidus.
What are the visible trends?
Clinical trial organizations are now innovating and working on customized approaches. There has been a wide scale technology adoption for digital informed consent, e-diary, digital biomarkers, e-health record management, and easy access to the availability of information on health and services. The use of the internet and mobile has paved the way for tech-driven trials in this industry. Virtual monitoring and digitization have reduced the time taken for research. Additionally, AI has augmented human expertise like smart advisors for scientists, robots for skilled workers, and computational creativity for designers. This approach has been approved and applauded by the regulatory authorities as well. Patients have also started taking a keen interest in supporting and gaining more knowledge of trials.
The increased participation of people can also be attributed to the steps taken by regulators to ensure their safety and convenience. Technology has been leveraged to reduce the physical contact and effort by adopting techniques like virtual meetings, reviewing documents electronically, etc. Another robust intervention has been through making the drugs available to the participants via direct shipment to their residence and providing tele-medicine services. This ensured that patients who are unable to visit the hospital for health and security reasons can also participate in the trial without compromising on their safety.
India is emerging as the global development hub and will continue to evolve in this area for the next decade as well. However, implementation of some of these technologies arrives with huge investments which could be slightly challenging. People, in general, have become more aware of the importance, safety, and efficacy of clinical trials along with the need for drugs and vaccines. The pandemic has changed the outlook for many countries and innovation is the key to various ongoing and future developments.
What is the key issue impacting the growth of the sector here?
India provides a lucrative opportunity for the clinical trials because of the robust guidelines and systems that it has put in place. However, the challenge which the country is currently facing is primarily focusing on India-centric trials and not pushing for more global trials. This means that the country is not making use of its capabilities to the optimal level which is not allowing the growth of the industry. As a hub for clinical research, India has now come a long way and has made necessary regulatory and implementation changes to make the process In line with internationally accepted good practices in clinical research.
For the smooth functioning of the industry, cooperation among various stakeholders like sponsors for research, government, academia, clinical investigators, physicians, regulators, and the government is necessary. Each stakeholder is important as they offer different expertise required to support essential components of a trial. Cooperation, adoption of technology, patient recruitment, and managing costs also pose challenges. To alleviate this challenge of participating in global clinical trials, SIRO entered into the ACROSS global Alliance of Clinical Research Organizations. Among the many benefits, include the opportunity to assist ACROSS’s clients in India, whilst ACROSS and its Partners can assist SIRO clients with their overseas (i.e., outside India) clinical expertise.
In your opinion are the regulations adequate in clinical trials and what needs to be done?
The government has extended timely support for companies involved in the clinical research sector. The regulatory framework changes have led to easy approvals and adoption of digital technology for increased transparency and clarity. New rules introduced are clear and in favour of the current market trends for the development of clinical trials.
In June 2019, the Ministry of Health and Family Welfare published its final version of the New Drugs and Clinical Trial Rules. The regulations brought under this version have given an important push to the clinical trials providing more clarity on the regulatory pathway, compensation guidelines, clarity on audio-visual consenting , ensuring time-bound implementation of application review, and making the post-trial access better. There has also been more clarity shared on a clearly defined pathway for global clinical trials. All these mentioned changes have added much needed clarity and make India an attractive destination for clinical research.
There has also been a push to promote research in development of orphan drugs, which are drugs developed for any disease that affects not more than five lakh persons in India, as defined in the new policy. To promote this, the policy proposes measures like fast-track approval and complete fee waiver for CT filings.
Which of your partnerships has transformed and strengthened your services?
We believe that our strategy to associate with BA/BE CRO, Azidus Laboratories and gain entry into a global alliance of CROs which is ACROSS Global will continue to support our growth in clients, service offerings and geographies. We have a track history of implementing global clinical trial services for the last 2 decades so we are hoping that our alliances will facilitate global trials once again.
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