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Covid-19 has marked a new era for us in the accelerated development of vaccines to address urgent public health needs of an unprecedented scale, according to Dr Chirag Trivedi, president, Indian Society for Clinical Research (ISCR).
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.
Early on during the Covid-19 pandemic, the Indian regulators laid down guidelines and processes for the accelerated development and approval of drugs and vaccines during the pandemic and we have seen many sponsors move forward with clinical trials, including in the vaccine space. This has encouraged innovation and also catalysed the rapid implementation of technology and digital processes to speed up development efforts which has been good for all of us, he further added.
The New Drugs and Clinical Trial (NDCT) Rules, 2019 has created a more robust and scientific framework for the conduct of clinical trials in India. Besides this, it has brought greater clarity and speed in the regulatory approval process for clinical trials, while ensuring that patient safety is not compromised, according to regulatory experts.
“We now need more clinical trials to be conducted in India to find newer treatment options for the unmet medical needs of our Indian patients and those across the world. We saw efforts begin with Ebola and H1N1, but the needs of Covid-19 were far more urgent and much larger. It required far more collaboration between academic and industry, between industry and government, between governments and finally, between regulators and all these stakeholders. However, we cannot compromise safety, quality and ethics in the pursuit of speed and that is most important as clinical researchers – that we do what we have to do with our focus on patients and their safety,” Dr Trivedi explained.
Talking about the rights and safety of clinical trial subjects, Dr Trivedi said, “Patient protection and safety is at the core of any clinical trial. The NDCT Rules, 2019, Indian Good Clinical Practices (GCP) guidelines and the ICH-GCP Guidelines have a lot of processes in place for the protection of clinical trial participants. However, it is equally important that the trial participants are aware of their rights and responsibilities during a clinical trial and in fact, ISCR a few years ago developed an FAQ Guide for clinical trial participants that addresses many questions they may have about their participation in a clinical trial. All stakeholders, including the media, must ensure that they respect and recognise patient confidentiality and the rights of every clinical trial participant to have their identities protected.”
For a country that has the world’s second largest population and the world’s highest disease burden, India’s share of global clinical trials has continued to drop over the years and is currently 1.16% as per www.clinicaltrials.gov.
According to experts, more needs to be done and this is a collaborative effort required by all stakeholders so that research and innovation is given more priority and more awareness is created about India’s competence as a clinical research centre.
“We need to build trust and confidence about clinical trials in the minds of public. The government can play an important role in facilitating this through formulating and revising policies that will facilitate the conduct of ethical and good quality clinical trials in India,” Dr Trivedi concluded.
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