Gappa Tappa corner thread 11 - general discussions - Page 70

Originally posted by: NerdyMukta

@bold- I hope you didn't literally mean what you just stated above.

Not literally but what I meant was that the authorities and the institute guys should be interacting virtually daily to see that the permissions for trials are not going through the typical Govt. "file movement" procedure.

Here is something very interesting from the operational head of Serum Insitute. He seems pretty confident of the efficacy and deployment by december.

https://www.youtube.com/watch?v=ku6VK48_P5c

Originally posted by: kamalsh56

Not literally but what I meant was that the authorities and the institute guys should be interacting virtually daily to see that the permissions for trials are not going through the typical Govt. "file movement" procedure.

I understand the desperation and the need of this hour. Having said that, one has to accept and follow the policies and procedures laid by Regulatory health authorities across the globe; whether its US FDA or EMEA.

Originally posted by: kamalsh56

Here is something very interesting from the operational head of Serum Insitute. He seems pretty confident of the efficacy and deployment by december.

https://www.youtube.com/watch?v=ku6VK48_P5c

Of course he is confident. So far I read about 6 centers in Arizona and one in Florida. 30K volunteers in US alone...10K in UK. Key point to note from Phase 1 study is that it was done in age group 18-55. Phase 2/3 is hybrid model where they are augmenting clinical trial setting with telemedicine and digital devices.

Originally posted by: NerdyMukta

Of course he is confident. So far I read about 6 centers in Arizona and one in Florida. 30K volunteers in US alone...10K in UK. Key point to note from Phase 1 study is that it was done in age group 18-55. Phase 2/3 is hybrid model where they are augmenting clinical trial setting with telemedicine and digital devices.

What's that? How can they run a clinical trial remotely?

Record 10k per day new cases in Maharashtra today.

Originally posted by: NerdyMukta

I understand the desperation and the need of this hour. Having said that, one has to accept and follow the policies and procedures laid by Regulatory health authorities across the globe; whether its US FDA or EMEA.

What I meant was that the Indian authorities should not ask Serum Institute to fill up the application form in triplicate and courier it to the department head between 9 am to 5 pm and then they say we will move the application through the various departments, the bureaucracy takes over and wastes precious time to permit the conduct of the trials in India. Every week is critical with 100's dying here every day.

Originally posted by: kamalsh56

What I meant was that the Indian authorities should not ask Serum Institute to fill up the application form in triplicate and courier it to the department head between 9 am to 5 pm and then they say we will move the application through the various departments, the bureaucracy takes over and wastes precious time to permit the conduct of the trials in India. Every week is critical with 100's dying here every day.

It is a pity that even with so much progress in Information Management and so many IT professionals in India, we are still in the 20th century. I hope and pray that bureaucrats tighten their reins and act sensibly.

** New Marathi webseries Idiotbox releasing on mxplayer on Friday. Spruha, mrunal k, p. tarde, Abhijit khandkekar, pushkar jog, & so many artists. Co-director is mrunal"s son Virajas Kulkarni (hero of MHN).

Originally posted by: kamalsh56

What's that? How can they run a clinical trial remotely?

Not all of the clinical trial. Some safety visits are done via teleheath platforms. And vitals collected via digital devices; data collection is done on a cloud based platform. EMR data is remotely monitored and analyzed real time.