TRIALOMICS Archives | Future Medicine India

TRIALOMICS

COVID-19 vaccines in the Real World

Vaccines against the SARS-COV-2 virus received emergency use approval based on short-term efficacy against symptomatic COVID-19 in clinical trials.

Dr Arun Bhatt
Read More..

Societal interest vs individual rights

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.

Dr Arun Bhatt

Post-vaccination antibodies and efficacy

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.

Dr Arun Bhatt

Trials and tribulations of assessing safety

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.

Dr Arun Bhatt

Compliance to GCP for academic research

International Council on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines are considered the global standard for all types of clinical research.

Dr Arun Bhatt

Prophylactic therapy trials for COVID-19

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.

Dr Arun Bhatt

Platform clinical trials: An innovative approach

The search for an effective treatment for COVID-19 continues to be a major focus for the world’s clinical research community.

Dr Arun Bhatt