While Favipravir and Coronil Trial are being criticized for lack of Blinding and gaining approval via Press Release. Have major drug trials done better?
1. RECOVERY. Open label(No blinding). Evidence dexamethasone + . HCQ arm-(press release, pre-prints 2 week later)
1. RECOVERY. Open label(No blinding). Evidence dexamethasone + . HCQ arm-(press release, pre-prints 2 week later)
2. SOLIDARITY Trial(WH0). No Blinding(open label)
3. Lopinavir/Ritonavir for Severe COVID. No Blinding.(responsible for dropping Lopinavir/Ritonavir from Indian guidelines in march)
3. Lopinavir/Ritonavir for Severe COVID. No Blinding.(responsible for dropping Lopinavir/Ritonavir from Indian guidelines in march)
4. Univ of Minesotta Hydroxychloroquine trial. Double Blind ,but imperfect blinding (Patient could guess Drug/Placebo in 50% of cases)
5. Remedesivir (open label and Double Blind). Included in CDC,USA guidance on basis of press release.) Paper published a month later.
6. DISCOVERY trial (ongoing.open label)
6. DISCOVERY trial (ongoing.open label)
Generating Quality evidence is tough. In Time of Pandemic Everybody is trying to do their Best.
So since we don't have perfect "trials" .how should we look at Evidence
So since we don't have perfect "trials" .how should we look at Evidence
1. Look for hard end points (mortality, virological remission (2 PCR negative)
2. For soft end points (symptoms , radiology). V. Difficult.
3. Reputation of Trial group(NIH,NHS).Did they follow due process (adjusted interim analysis etc n announced regularly)
2. For soft end points (symptoms , radiology). V. Difficult.
3. Reputation of Trial group(NIH,NHS).Did they follow due process (adjusted interim analysis etc n announced regularly)
