Covid and its impact on clinical research industry

The World Health Organisation (WHO) declared coronavirus disease-19 (Covid-19) a global public health emergency in late January 2020. Covid-19 is a newly recognised coronavirus strain that initially infected people in Wuhan, China following the rest of the world. The novel coronavirus (Covid-19) pandemic has generated an exceptional global health emergency. Due to the sudden onset of the disease worldwide and its pervasive impact, all industry sectors are functioning to measure both the impact and the ideal path to move forward.

The Covid-19 had a mammoth impact on the technique manages and demeanours clinical trials in India and globally due to the urgent medical requirements aroused because of the pandemic. Usually, it takes 8-10 years for a drug to get the approval of marketing. Conversely, in 2020, the development of Covid-19 vaccine across countries accelerated this procedure, despite the fact that patient safety, quality and efficacy will not be negotiated. The Regulators and the Ethics Committees reviewed the protocols and amendments related to vaccine trials on priority. These rapid actions lead to reduced approval timelines and some virtual processes like site monitoring and visits further reduced time to complete the clinical trial process.

The FDA, EMA, ICMR and other regulatory agencies issued guidance on conducting clinical trials during COVID -19 pandemic, keeping in mind that the study participants should not get exposed to coronavirus and in addition emphasising on the significance of protecting study participants well-being, safety and preserving Clinical trial integrity, quality and efficacy. These guidelines prioritise research review based on urgency and take needful steps to facilitate the review of new research and conduct ongoing research with needful amendments as per need in the view of social distancing norms.

The FDA, EMA, ICMR and other regulatory agencies issued guidance on conducting clinical trials during Covid-19 pandemic, keeping in mind that the study participants should not get exposed to coronavirus and in addition emphasising on the significance of protecting study participants well-being, safety and preserving Clinical trial integrity, quality and efficacy.

In this pandemic, working from home has become a new normal for many industries and the clinical research industry is no exception. Sponsors, CROs and other related organizations have also adapted to working remotely. It is estimated that 80% of non-Covid-19 trials were stopped or interrupted because of the Covid-19 pandemic in many countries. In one example, Prevention Bio was forced to temporarily pause a phase 3 study evaluating its investigational therapy for type 1 diabetes similarly Eli Lilly, Bristol-Myers Squibb and Pfizer also have multiple development programmes that are paused or delayed.

Pharmaceutical and Biotechnological industries stopped or delayed the trials that are inpatient recruitment phase. Clinical trials that were in the development phase with a full enrolment of human subjects can be resumed eventually, however it may experience challenges like participant withdrawal, protocol violation and hopped hospital visits by the human subjects that could affect the efficacy and quality of trials and increase the probability of study termination. In contrast, many ongoing trials adopted new methodologies to overcome the challenges by transitioning to virtual approaches to interact with patients.

All Stakeholders should agree that there would not be a standardised solution for the many challenges; they are required to be more flexible, evaluate their risk and develop new strategies to withstand this predicament. In the years ahead, the clinical research industry should focus on technology-driven clinical trials for e.g., digital biomarkers, digital informed consent, e-health records directly feeding data to the e-CRF, etc. Decentralized trials, which require remote participation of the subjects, can also be adopted. Furthermore, in future, we will witness an enhancement in the patient-centric methods for designing and conducting clinical trials as the patient’s well-being, safety and rights are of utmost priority in clinical trials.

Not only the pandemic has caused challenges but also created awareness amongst the public about the importance of clinical trials, which was very important for the development of innovative treatment options for the patients