The sudden outbreak by COVID-19 has affected almost every aspect of life. According to the recent report as of September 212020, by World Health Organization (WHO), more than 31,186,000 cases have been confirmed worldwide including 962,343 deaths. Many of the on-going or/upcoming clinical trials related to non-covid-19 studies have been stopped or paused and the total focus shifted to the COVID-19 related studies. Therefore, in this study, we aimed to provide a systematic review on the rise and the fall of clinical research in the era of this pandemic.
COVID-19: An Unpleasant Surprise in 2020
The life we lived, the joy we felt, the song we sang, and the research we performed, all came to a halt, when the-so called coronavirus came into existence. Having had its root in China and spreading its branches all over the world, this virus paused the life we had. The world was hit hard when health care hubs became overwhelmed with severely ill-patients.
The ‘Novel Coronavirus’ or the ‘SARS-CoV-2’ infection spread via extremely contagious respiratory droplets. Even though COVID-19 is commonly a mild upper respiratory illness, many patients developed severe bilateral pneumonia leading to hospitalization for supplementary oxygen and supportive care, or respiratory failure demanding mechanical ventilation.
With the rise of the infection rate, it was determined that SARS-CoV-2 has the potential to spread from the lungs to other organs. The world adopted various preventive measures to stop the spread of infection which included:
- Travel restrictions
- Maintaining social distance and quarantine measures
- Avoiding mass gathering
- Closing of schools, colleges and encouraging work-from-home where possible
- Adherence to personal hygiene, and use of face masks
- Implementation of infection control measures in healthcare settings
Clinical Research at a Glance
Clinical research is a branch of medical science that aims to improve the quality of life. It is a highly regulated and safely monitored process that is carried out to achieve the safety and efficacy of medications, medical devices, and biologics etc. This area of research includes the study on mechanisms of human disease, the natural history of the disease, translational research, behavioral research, community-based research, health services research, detection, diagnosis, prevention, and health promotion. This study is carried out in ‘human subjects’ either having a specific disease (patient) or without any disease (healthy human).
Significance of Clinical Research
Clinical research helps prove a number of aspects in healthcare and medicine:
- Research in human physiology and pathophysiology reveals the mechanism of disease and medical therapeutics.
- Clinical trials, a part of clinical research helps establish the safety and efficacy of new therapies.
- The population at a higher risk can be potentially benefited from prevention and therapeutic intervention with early detection of disease.
- The outcomes of clinical research assess the health impact and cost-effectiveness of effective interventions.
COVID-19 Disrupting Clinical Research
COVID-19 has disrupted the progress of clinical research. Due to the implementation of safety measures like quarantine, isolation, and social distancing, there was not only difficulty in recruiting new subject, but there were lower follow-ups from recruited subjects. Many clinical research organizations stepped back for conducting new trials. Hence tons of trials were suspended depriving the function of the health care sector, vaccine industry, pharmaceutical and medical device companies.
In response to the challenges faced by the pandemic, the NIHR (National Institute for Health Research) prioritized COVID-19 studies. As a result, non-COVID drug development programmes and trials took a back seat and the front seat was occupied by COVID-related drug development and therapies.
The manufacturers of the largest pharmaceutical company like ‘Eli Lilly’, ‘Merck’, ‘Pfizer’, and ‘Bristol-Myers Squibb’ detained enrolment for on-going studies and also the initiation of future studies. According to data recorded by ‘BioPharma DIVE’ on May 15, 2020 nearly 100 companies and 240 trials experienced disruptions in their function. From the survey laid down by Global Data, the oncology trials were the highest disruptive trials followed by trials on the central nervous system. The infectious disease were the least effected trials as all most all the trials of this area are for the development of COVID-19 vaccines and therapies.
Vaccine Requirement: Enhancing Clinical Research
With these pandemic ebbs, new digital capabilities and new learnings continued to emerge, and the balance sheets of strong industry kept moving on.This sudden break out might have hit the sector’s productivity, but also raised the demand for vaccines and therapies spurring innovation at great height.
The development of vaccines usually takes years but as a response to the global health threat, the drug makers whittled down the process in just a matter of months. Many vaccines have been approved by the various regulatory authorities considering COVID-19 as an emergency case. Several trials have been conducted worldwide to treat COVID-19 in which India and the US rank first. Currently, the clinical pipeline is crowded with nearly 1,000 vaccines and drugs to discover the effective treatment and therapeutics involving 397 in the discovery phase and 573 in the preclinical phase.
Clinical Research Stronger Than Ever
According to experts and executives with certain smart moves, sooner or later the world will bounce stronger than ever as many industries, pharmaceutical companies and health care sectors have adopted a leaner and faster way of conducting clinical trials and drug development process to alleviate the suffering, extending life and well-being.
The surprise thrown by 2020 has revealed the significance of clinical research and the great importance of life sciences sector as a whole. The COVID-19 pandemic has bought tremendous strain on clinical research and its study outcomes, but as a favor, it has led many ways for the discovery of different treatment and therapeutics boosting clinical research and its related domains.