Regulation of Clinical Trials and Pandemic Research: Upholding Ethical Standards During a COVID-19 Crisis

Every element of society was disrupted by the rapid development of the COVID-19 pandemic, including the healthcare system, the supply chain, the economy, and interpersonal relationships. Safety and public health of the general public, patients, essential personnel, and healthcare professionals were among the numerous emerging considerations. Clinical trials focusing on the treatment and prevention of coronavirus infection were prioritized over studies focusing on other diseases in some regions, and clinical research was halted or terminated in deference to the pressing demands of patient care. Decisions had to be made quickly, and flexibility and rethinking were required due to the fact that knowledge of the disease and understanding of its treatment (and prevention) increased, as well as the fact that the intensity and severity of infection varied over time and by location. In an effort to improve future preparedness, this paper addresses the ethical difficulties in decision-making and competing ethical pressures during the epidemic. In a short period of time, the medical and science communities have made outstanding progress. We must apply what we have learned thus far to a "second wave," should one occur, or, in the absence of one, to the subsequent pandemic, in order to accelerate development. To do this, we need leadership, preparation, and strategy. Global collaboration is required to enable insights obtained in one location to be transferred to the next and to build upon knowledge rather than reinvent it as the wave of infectiousness spreads across nations. For this to happen, there must be agreed-upon common, objective endpoints and their definitions, collection of adverse safety events, electronic data capture and cloud computing, commitments to share protocols, consents, and common terminologies and ways of recording symptoms, co-morbidities, demographic and non-demographic characteristics of the individuals.