President, Indian Society for Clinical Research
It has been roughly a year since the SARS-CoV-2 virus hit and much has been written about the disruptive effects it has had on our lives. It has upended many practices that were hitherto considered to be the norm; from spawning remote-working trends to accelerating digital transformation across sectors. As the focus shifted to research and development of new drugs and vaccines to treat and prevent Covid-19, clinical trials received heightened attention and scrutiny.
Covid-19 had a huge impact on the way clinical trials are managed and conducted in India and globally due to the urgent medical needs arising from a pandemic that was of mammoth proportion. What changed in clinical in 2020 and what does 2021 augur for clinical research.
Clinical Trials in a Covid-19 Environment
Clinical trials are the pharmaceutical equivalent of a marathon. It often takes 8-9 years for a certain drug to reach patients and the bulk of this time is spent in the development process. However, in 2020, the robust race for development of COVID-19 vaccine across countries led to processes being fast-tracked, while ensuring patient safety, quality and efficacy were not compromised. Clinical trial protocols were amended to accommodate the flexibility that was required to mitigate the pandemic induced risks. The Regulators and the Ethics Committees accorded priority review for such amendments. These measures, while in no way reducing the rigour and robustness of the clinical trial process, resulted in reduced approval timelines and some virtual processes which further reduced clinical trial timelines.
Necessary changes for availability of faster drugs/vaccines in India
In India, there is a huge disease burden and existence of a large unmet medical need for our patients. This creates an opportunity to find newer treatment options for our patients locally. Covid-19 has brought to the forefront the need to strengthen India’s entire clinical research ecosystem so that it can effectively scale-up to meet the needs of Indian patients. Though, we will need to build our infrastructure at the back end to keep pace with the requirements.
The impact of Covid-19 on faster drug/vaccine availability has been enormous. Initial advancements to bring faster drugs in the markets was recently noticed with Central Drugs Standard Control Organisation (CDSCO) approving close to 60 trials in September and October 2020, of which approximately 25% were Covid-19 studies.
The road ahead for clinical research & trials in 2021
Taking steady steps considering the pandemic, the Regulators and the Ethics Committees in India accorded priority review for the amended clinical trial protocols. It is crucial that these steps should be continued in 2021 and beyond for India to have an important role in the global clinical research community.
When it comes to the methods of delivery, India is positioned to take advantage of its economical and scalable IT infrastructure to facilitate ‘new-age’ clinical research. Hybrid clinical tests that incorporate traditional methods with technologies like artificial intelligence and machine learning to provide real-time data on patient outcomes. This could streamline the development process and increase the speed with which drugs can be brought to market.
Clinical trials in India in 2021 and beyond is likely to see widescale adoption of digital technologies for e.g., digital biomarkers, digital informed consent, e-health record directly feeding data to the e-CRF, etc. With the increasing penetration of mobile and internet services, India is poised to lead the way in implementing tech-driven clinical trials. Remote-based, decentralised trials with patients participating in clinical trials from the comfort of his/her home would also be a big advantage in a country like India and in 2020, we have seen the regulators and the Ethics Committees agreeing with this approach. We are hopeful that this will continue in the future too. Additionally, we will also see an enhancement in the patient centric approaches for designing and conducting clinical trials as the patients are at the heart of all that we do in clinical trials.
Finally, the pandemic has caused wide-scale awareness amongst the general public about the importance of clinical trials to prove the safety and efficacy of drugs and vaccines. This should continue since it will aid greatly in the development of innovative treatment options for the patients.
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