Advancements in digital technology critical to clinical trials: Experts

Across the pharmacovigilance, biostatistics, medical writing and clinical data management sessions, panelists spoke of the digital-enabled regulatory flexibility during the pandemic

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New Delhi: Focusing on the rapid advancements made in digital technology and the accelerated advances in digital health during the pandemic, in particular, speakers and panelists across all tracks at the virtual 14th Annual ISCR Conference endorsed the growing relevance and importance of tech-enabled clinical trials in 2021 and beyond.
“The overarching themes that were highlighted during the two-day event were regulatory flexibility, adoption of digital technology, and a high degree of stakeholder collaboration during the pandemic all of which points the way forward for our Conference theme Clinical Research – Transforming Lives: 2021 and Beyond. Patient-centricity and a focus on safe, ethical, and quality clinical research will continue to guide the clinical research community,” said Dr Chirag Trivedi, President, ISCR.   
“As we think about regulatory strategies and clinical research approaches that make drug development affordable,  digital health technologies have the potential to offer the solutions needed to transform clinical trials,” said Dr. Kiran Mazumdar Shaw, Executive Chairperson, Biocon Ltd, while delivering the keynote address on the second day. “We need to apply and leverage digital health, algorithms, data science and health information to drug development and enable bringing drugs to market faster. This will also result in much more innovation and investments in R&D and clinical trials will explode.  With the rise of computing power and the US FDA’s stand on digital tools, we are looking at a paradigm shift in clinical research that is focused more on digitization. India must take advantage of the opportunities digital health offers.  Let us resolve to shape and build a clinical research world that is predictive, precise and results in better patient outcomes,” she added.
The second day’s proceedings witnessed power-packed sessions around academic clinical research & pharmacovigilance, effective clinical data management, biostatistics, and statistical programming, and medical writing. Summarizing her views on the year 2020 for clinical trials during a panel discussion on ‘Clinical Research – Transforming lives: 2021 and Beyond,’ Dr. Rubina Bose, Deputy Drugs Controller, CDSCO, said, “Regulators were at the forefront right from the onset of the pandemic. By taking a Patient First approach, we enabled bringing imported COVID-19 kits for early detection into India at the initial stages. Collaboration across different institutions and government ministries played a crucial role in tackling the pandemic effectively. As everything moved to digital, it allowed us to reduce the timelines for approvals, which was vital for furthering research and trials in the country. As we move into 2021, we need to continue to ensure resource maximization, transformative use of digital platforms and build capabilities.”
While speaking on expectations from stakeholders, she added, “Clear understanding of the regulatory pathway is exceedingly crucial. As data credibility is of utmost importance, researchers must collect, understand, and always validate their data. We are working collaboratively with different scientific and academic institutions and have we have built an ecosystem which must be continued even after the pandemic ends.”
The conference also shed light on how various stakeholders were able to incorporate advances in technology to streamline and expedite processes during the pandemic. Commenting on the National Guidelines for Ethics Committees Reviewing Biomedical and Health Research During COVID-19 Pandemic, Dr. Roli Mathur, Head Bioethics Unit ICMR, WHO Collaborating Centre for Strengthening Ethics in Biomedical Health NCDIR, Bangalore, said, “The principles of ethics and scope of the guidelines were not only limited to the biomedical realm but were also from a socio-behavioral perspective. The National Guidelines stressed the need for expedited, unscheduled, and virtual meetings as per the requirements. Since digital technology was being enabled, communication on privacy and protection of the data was also a key component.”
Across the pharmacovigilance, biostatistics, medical writing and clinical data management sessions, panelists spoke of the digital-enabled regulatory flexibility during the pandemic which had helped bring drugs faster to market and stressed that this needed to continue.
Earlier in day, the National Awards for Excellence in Academic Clinical Research were give to Dr Kavita Singh, Research Scientist, Public Health Foundation of India and Dr Tuhina Banerjee, Prof, Institute of Medical Sciences, Banaras Hindu University under the early career research category, and Dr Bhavuk Garg, Additional Prof, All India Institute of Medical Sciences and Dr Prashant Kumar, Faculty Scientist, Institute of Bioinformatics under the mid-career research category.