At times, one has to write just to record for the history. That, a country's regulator invites media for webinar on clinical trials and when a question is asked, the reply is this 👇
"My request was to limit the question regarding understanding the processes involved. About the specifics of the things you are questioning, there are forums…there are weekly press conferences by department / ministry. This question can be asked there." downtoearth.org.in/news/health/dr…
Other issues related to CTs which were asked but were not taken up due to 'paucity of time':
The composition of ethics committees of institutions where these trials are going on
The role Central Drugs Standard Control Organisation’s own subject expert committee
Study designs and protocols
Data provided to SEC for granting permission to proceed to progressive phases of trials
Criteria for pausing a trial in India
Whether the DCGI would put all the related data in the public domain
(So on and so forth)
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So a media report says #DCGI has refuted any causal link between the serious adverse event (SAE) and #SII COVID vaccine trial participant. When we posed ques to the health ministry secy on December 1, he asked us to look into New Drugs and Clinical Trial Rules, 2019 (1/n)
What these Rules say (in case the death hasn't occurred) 1. The sponsor and the investigator shall forward their reports on an SAE to the Central Licencing Authority (DCGI), ethics committee and the head of the institution where the trial was conducted within 14 days of SAE(2/n)
2. The ethics committee shall forward the report and compensation to be given by the sponsor within 30 days of knowing that the SAE had occurred. 3. The DCGI shall pass an order or constitute an expert committee. (3/n)
1.Out of all the tests done in India so far, can Dr Gangakhedkar clarify how many individual people been tested,and how many second, third, fourth tests etc have been done?- Some states have announced they will expand testing criteria from ICMR's criteria. Are they allowed?
2. Will those positive results be accepted by the Centre? 3. How many ILI and SARI patients come up in hospitals across the country over the last two weeks?Also, how many samples of such patient have sentinel surveillance been conducted on? 4. How many Docs are tested positive