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Changing Clinical Trials

The pandemic underlined the scale to which our current site-based clinical trial model is costly which in turn limits the populations being served and burdens trial participants. The present crisis demands a paradigm shift in the traditional ways of conducting clinical trials.

Thousands of clinical trials all across the world were disrupted, delayed or stopped while countries struggled to curb the pandemic and research resources were redeployed. The long-term impacts of the turmoil caused by the COVID crisis have yet to be completely understood, but it's already clear that the increased focus on participant needs' and on the logistical challenges of current models are not likely to go away soon. This disruption is opening ways for revisiting traditional approaches to clinical trial conduct.

Dr Satyanarayana Mysore, HOD & Consultant - Pulmonology and Lung Transplant Physician, Manipal Hospital Old Airport Road underlines, "COVID sprung on us got everyone unaware, with not much weapons in the therapeutic armamentarium, it was all but experimental medications. Number of clinical trials are quickly done and the legacy of the clinical trial is the good and efficacious vaccines that we are having including the India's own ingenious Covaxin. Clinical trials are difficult to recruit patients and they should be rigorous in justifying whether a treatment is required or not."

He further adds, "The clinical trials will in future be our new dynamic weapon against this problem of mankind." 

Opportunities and disruption

Clinical trial is the foundation of present-day pharmaceutical drug development. Nonetheless, the basic proposition in clinical research of testing the efficiency and safety of therapeutics under controlled conditions has been affected by the pandemic’s health concerns about congregate settings and ongoing social distancing needs. In the spring of 2020, public health measures all across the world (including institutional guidelines, compulsory lockdowns and individual behaviour patterns) mingled to bring clinical trials virtually to a pause. As of January 2021, there were more than 2000 clinical trials that had been put to an end mainly due to COVID restrictions. Even for trials that continued, confined access to medical facilities and missed clinical visits became a global reality as the travel restrictions were implemented and capability to access medical facilities ended.

Health authorities quickly acknowledged the disruption in clinical research and provided emergency guidance on trial participant safety and ensured quality in clinical trials. These were meant to assist trial sponsors during these unprecedented times and provide high level guidance on trial conduct. Nonetheless, the challenges that sponsors face - related to corresponding missing data in clinical trials and missing clinical site visits were not specifically addressed.

At the same time, organizations quickly shifted resources and efforts to testing and research of COVID-19 vaccines and therapeutics. In this moment of universal crisis, scientific and governmental and health communities worked together with continued focus & collaboration and sharing learnings across nations, companies and institutions as never before. Within few months of the outbreak, the global community figured out that a new respiratory issue was coming into existence due to a novel Coronavirus and had mapped its genetic sequence. By April 2020, more than 200 fresh COVID-19 clinical trials were launched resulting in both prevention solutions and treatment. These trials incorporated cooperation among companies, institutions and countries and have resulted in successful approaches for fighting COVID.

Advancing clinical trial conduct

The pandemic underlined the scale to which our current site-based clinical trial model is costly which in turn limits the populations being served and burdens trial participants. In one report focussing on large, global clinical trials, around 11 per cent of sites failed to enroll a patient, 40 per cent of clinical site failed to meet recruitment goals and 49 per cent of those enrolled dropped out prior to the completion of the study. Even prior to the pandemic, there was a great interest in decentralised clinical trials and digital health. The know-how to facilitate virtually conducted clinical trials has been available for years. Though the traditional reimbursement cost structures and administrative obstacles have made the implementation difficult. But in 2020, sponsors were forced to create processes and capabilities for conducting clinical trials without clinical site visits. Although telehealth capabilities have been in existence for years, the utilisation of telehealth extended exponentially during 2020 in clinical research and in healthcare more broadly.

Dr Anil Thakwani, Director-Oncology, Sharda Hospital Greater Noida says, "As trials are run on a budget so managing clinical trials efficiently is a necessary part of conducting clinical trials."

He suggests that "pharmaceutical and drug companies must develop and implement hybrid strategies, providing multiple routes of access to clinical trials. Socio-economic and other health disparities should continue to be addressed in the broader healthcare and population services ecosystems."

Summing up

In the last few years, there has been an increased use of technology to develop new ways of working, collaborating and connecting. A highlight in all of this is the opportunity to reimagine how we leverage technology to make our lives better - from the bench scientist, to the patient, to the researchers working vigorously to find improved treatment for human disease.

Clinical trials will be more patient-centric in the future. Clinical site visits will be gone and more clinical trial conduct will shift to participants’ homes. We have begun to see this transformation which has accelerated during the pandemic. The use of technology will provide access to clinical research on an uncertain scale through decentralised trials. As long as individuals have access to the internet, they can enroll in trials without the need to be physically co-located. If practised correctly, this paradigm shift can increase trial diversity, better aid underserved populations and advance treatment access globally.



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