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ISCR to focus on digital adoption in clinical trials

Yash Ved, Mumbai
Monday, April 19, 2021, 08:00 Hrs  [IST]

The Indian Society for Clinical Research (ISCR) will increase focus on digital adoption in clinical trials and foster greater collaboration among all stakeholders, the newly elected ISCR president Dr Sanish Davis said.

Dr Davis, stated, “The lessons from clinical trials during the pandemic will act as a catalyst to transform how we do clinical trials in the future and I am excited about the possibilities. We are extremely grateful to the regulatory agency for pushing the agenda for digital adoption by streamlining application process for clinical trials in Sugam, having virtual SEC meetings and for making the review and approval process completely digital. With the recent adoption of moving serious adverse event (SAE) reporting to the online platform Sugam, the agency has shown the way in transforming digital adoption in clinical trial conduct.”

The importance and value of digital adoption in clinical research could not have been demonstrated more than it has been during the pandemic. This was highlighted in several panel discussions at the recently concluded 14th Annual ISCR Conference as speakers shared that swift advancements and rapid adoption of digital health technologies have the potential to offer solutions needed to transform clinical trials in India.   

Dr Davis stated that drug research and development is a time-consuming process that starts with identifying a potential therapeutic target and then going through a series of tests and trials in the lab and in the real world to determine its safety and efficacy. It takes an average of 7-10 years and anywhere up to US$ 2 billion to bring a molecule to market.

Focusing on expedited trials that are required to meet the needs of Covid-19 treatment and prevention has opened pathways to innovation and technology.

ISCR added that this has resulted in faster and more streamlined processes without compromising on the rigour of clinical trials or the focus on patient safety. It is now important for all stakeholders to collaborate while embracing the learnings from the pandemic and incorporating advances in digital health for bring more effective drugs to market faster.  

The overarching themes that were highlighted during the two-day ISCR Conference 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 the ISCR 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, says ISCR.

“Ethics Committees in India have also shown a great digital adoption quotient by moving the review and approval of proposals at the site level to a virtual format. The general public is now far more aware of the relevance of clinical trials and we need to build on this to ensure greater appreciation of and recognition for clinical research in India,” added Dr Davis.

ISCR is an association of clinical research professionals that aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics. To that?extent,?ISCR is?fully?supportive of the initiatives undertaken by regulatory authorities to create a more robust and regulated environment in India for the conduct of clinical research and will continue to work very closely with different stakeholders in the development of regulations that will safeguard and protect patients in a clinical trial.

 

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