Virtual clinical trials would have a tremendous advantage in expanding the reach of clinical trials

How did CROs like IQVIA cope with lockdown restrictions, to ensure minimum disruption of clinical trials as well as patient and staff safety?

Given that the lockdown was announced suddenly and unexpectedly, there were initial challenges with ongoing studies due to the restrictions in place. It was the perseverance and commitment of our clinical team that ensured patient safety, delivery of supplies, protocol compliance and overall study continuity. Despite all the challenges, the team worked relentlessly in collaboration with other stakeholders and were able to ensure studies were not impacted and, most importantly, that the health, safety and well-being of patients were safeguarded.

Right from the early stages of the pandemic, we had guidance in place to protect our employees and ensure that their own safety was in no way compromised. The guidance was more stringent for our site-facing staff. As in-country restrictions were tightened, and subsequently eased, the guidance was revised, ensuring continued focus on employee safety.

At a global enterprise-level, IQVIA’s Research & Development Solutions COVID-19 task force quickly mobilised to develop a standardised approach to risk assessment for both in-flight and new clinical trials.

What are the changes in clinical research/trial execution that were good learnings that will stay in place post lockdowns? (like increased remote patient monitoring, adaptive trials, etc)

The overall shift to digital and technology-based platforms has been a positive development of the pandemic. The virtual environment has forced the adoption of new ways of working even for regulators, like online reviews by Subject Expert Committees, without compromising on the rights, safety and wellbeing of patients, the scientific validity of the study, data integrity and quality, and ethics. The value of technology-enabled innovation has become very evident and if we are to meet existing unmet medical needs and those accelerated by the pandemic, we need to fundamentally change our approach to drug development by leveraging technology.

Virtual clinical trials (VCTs), also called remote or decentralised trials, is one such approach to conducting clinical trials that is likely to evolve further in India. It represents a relatively new method of conducting clinical research taking full advantage of technologies such as apps, electronic monitoring devices, telemedicine and online social engagement platforms. In a country like India, virtual clinical trials would have a tremendous advantage in expanding the reach of clinical trials and providing access to diverse patient populations, but it would also help address one of the toughest challenges in a clinical study which is that of patient recruitment. However, virtual clinical trials also require us to review and evaluate every step of the existing clinical trial process and put in place measures to address some of the likely challenges including but not limited to informed consent process (electronic consent), cold chains to ensure Investigational Product (IP) delivery to patients and samples to labs, facilitating home health nursing particularly in smaller towns and remote locations. Multi-stakeholder consultative meetings will be required by the regulators to deliberate on these issues and put together an approach path for India.

Could you give some examples of how your team successfully conducted a clinical trial during the lockdown, with all compliances in place as well as safety for all concerned?

Doing a COVID-19 study in the midst of a lockdown challenged us like never before. We had to find innovative solutions that did not, in any way, compromise the safety of patients or our own employees. Given that we have teams across the country, we were able to mobilise resources and capabilities across our businesses, set up virtual war rooms and leverage technology to deliver in a virtual world. All this, while ensuring compliance with the study protocol and that the stringent guidelines for the conduct of clinical trials in India were followed as well as very short timelines and turnaround times were achieved.

Has it been tougher to recruit patients during COVID times? How are these issues being handled?

During the initial stages of the lockdown, submission of new applications was delayed, and our focus was therefore on ensuring continuity of supplies and protecting patients in ongoing studies. Post the lifting of lockdown restrictions and with new studies, this has not been so much of an issue. On the other hand, with COVID-19 studies in particular, we see a lot more people keen to volunteer and support a larger humanitarian cause.

Has the CRO sector revived to pre-COVID levels?

Due to the pandemic and lockdown in India, some of the ongoing global clinical trials were temporarily impacted, and submission of new applications were also delayed during the initial stages of the lockdown. But from April 2020, after the Drugs Controller General of India (DCGI) enabled virtual Subject Expert Committee (SEC) meetings to review various proposals, global trials applications have been regularly submitted, reviewed and approved. Studies that were on hold have also restarted. There have been a large number of COVID-19 studies which has kept the CRO industry busy and we are likely to see the trend continue in 2021 in addition to non-COVID-19 studies which organisations put on hold likely to be initiated.

As we cope with new pathogens like SARS-CoV2, pharma R&D followed by clinical research and trials has become all the more important. But how can the sector ensure that patient safety is not compromised as these medicines are rushed through the trial process, in the face of public and political pressure?

It is important that we in the healthcare industry remain focused on the science and ethics of what we do and not get distracted by pressures, political or otherwise. Quality, ethics and patient safety cannot be compromised at any cost. A fast-tracked study does not imply a compromise on important processes. In fact, on the other hand, such studies require double the scrutiny and focus because of the never-before-speeds at which they are being done. It is equally incumbent on the industry to ensure transparent and open communication. We need to continue building public trust and education, awareness and transparent communication built on a scientific platform are critical to ensuring this.