The COVID-19 impact

The pandemic has brought a paradigm shift in the conduct of clinical trials

The COVID-19 impact

The COVID-19 pandemic has disrupted all aspects of medical care and created a healthcare crisis. This has had a negative impact on the conduct of clinical trials. On the one hand, 1,853 clinical trials have been launched to find an effective therapy since Jan 20 (Cancer Research Institute), while on the other, 1,118 clinical trials for non-COVID conditions have been stopped. This is in line with the adverse impact of the pandemic seen on various aspects of clinical care.

Clinical researchers have faced a variety of challenges in conducting trials in COVID-19 times. Fear on the part of the patients, unwillingness or inability to come to the site, managing staff time to conduct telemedicine visits and the limited availability of research staff and support services such as radiology have affected the conduct of trials. Infection with coronavirus in a clinical trial patient would make an assessment of response to treatment and safety difficult. This may result in discontinuation of the study. Sites have been concerned about time-consuming Interactions with sponsors about changes in processes and ethics committee discussions focussed on protocol deviations and the protection of rights, safety and wellbeing of participants and the shipping and administration of parenteral study drugs to patients. 

Overall, the pandemic has reduced enrolment of patients and affected protocol compliance. Clinical trials have been suspended or stopped in a) in vulnerable populations e.g. elderly, immunocompromised, pulmonary patients; b) those requiring personal follow-up visits or prolonged hospitalization and d) in hospitals or locations with high COVID-19 incidence. Sponsors face risks of missing or delayed data collection from ongoing trials. The high prevalence of asymptomatic patients and the probability of a second wave of coronavirus infection are potential hurdles to the resumption of normal clinical and research operations. 

The adverse impact of the pandemic has also offered opportunities to improve clinical trial conduct. Virtual meetings and the use of electronic documents have improved the efficiency of the ethics committee review process. Widespread adoption of telemedicine for remote interaction with patients is a major step forward in obtaining vital information on safety and efficacy endpoints. In addition, lab collection and delivery of study drugs have made the clinical trials patient-centric and patient-friendly. 

As the sponsor’s monitors cannot travel to study sites, they have conducted remote visits. Monitoring visits conducted on virtual web platforms are used to conduct initiation visits to train the site team, and to perform monitoring to ensure human subject protection and data integrity. The most important monitoring task — source verification of key data-informed consent documentation, selection criteria, adverse events and serious adverse events, investigational product accountability, compliance to study procedures, efficacy and safety endpoints – requires a comparison of scanned hospital/clinic records or electronic health records with data captured in electronic case record forms. However, ensuring confidentiality and privacy of patients is a must during such remote monitoring. 

The use of IT platforms enabling remote work is expected to improve employee productivity and satisfaction, increase staff retention, manage space issues at sites/offices and reduce time and expense. Let us hope these adaptations will lead to a paradigm shift and improve the efficiency of the clinical trial system! 

Writer is a consultant on clinical research & development from Mumbai. arun_dbhatt@hotmail.com

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