Vaccines against the SARS-COV-2 virus received emergency use approval based on short-term efficacy against symptomatic COVID-19 in clinical trials.
Post-trial access (PTA) of an investigational new product is an ethical right of the clinical trial participants. Usually, the option of PTA is available to the participants after the clinical trial is completed.
Clinical development of vaccines to counteract SARS-CoV-2 infection assumes that neutralizing antibodies (NAbs) directed at the spike protein will provide protection against the disease.
The assessment and monitoring of safety during clinical trials is a vital component of developing COVID-19 vaccines. Expected local and systemic adverse reactions (AR), which characterize the reactogenicity of vaccines, are common.
International Council on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines are considered the global standard for all types of clinical research.
The COVID-19 pandemic is a new and serious malady in search of effective therapies. Randomised clinical trials (RCTs) have been conducted to gauge the efficacy of dexamethasone and remdesivir.
The search for an effective treatment for COVID-19 continues to be a major focus for the world’s clinical research community.
Clinical research investigators conducting trials of investigational therapies face challenges of obtaining consent from COVID-19 patients who may seem incapable to do so or whose family members or legally acceptable representatives (LARs) are not available.
The catastrophic impact of COVID-19 pandemic on millions of lives and the world economy has compelled the pursuit of a protective panacea – a vaccine – mandatory.
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.
Leonardo Velazco-Cruz et al demonstrated a breakthrough study by converting human pluripotent stem cells (hPSCs) into stem cell-derived β cells (SC-β cells) as a promising alternative source for diabetes cell replacement therapy.
