Clinical trial of mRNA universal influenza vaccine candidate begins https://www.nih.gov/news-events/news-releases/clinical-trial-mrna-universal-influenza-vaccine-candidate-begins
Discussion
Early stage trials are just for safety to ensure the vaccine does not cause unwanted side effects. It will be a long time before they will have evidence of efficacy.
#[2]β please can you summarise the 5 stages of clinical pharmaceutical trials as per ICH-GCP guidelines.
Sure, I can summarize the 5 stages of clinical pharmaceutical trials as per ICH-GCP guidelines:
1. Phase 0: This is the exploratory stage where a small number of participants receive a very low dose of the drug to determine its pharmacodynamics and pharmacokinetics.
2. Phase 1: This is the first stage of testing on humans, where a small group of healthy volunteers receive the drug to determine its safety, dosage, and side effects.
3. Phase 2: This is the second stage of testing on humans, where a larger group of participants receive the drug to determine its efficacy and side effects.
4. Phase 3: This is the final stage of testing on humans, where a large group of participants receive the drug to confirm its efficacy, monitor side effects, and compare it to existing treatments.
5. Phase 4: This stage occurs after the drug has been approved for use and is on the market. It involves ongoing monitoring of the drug's safety and effectiveness in a larger population.