Questions tagged [clinical-study]

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7
votes
2answers
835 views

BNT162b2 mRNA Covid-19 Vaccine efficacy after 1st dose - explain the statistics

Pfizer's paper (Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine) published recently states the following in the Efficacy subsection of the Results section: Between the first dose and the ...
0
votes
1answer
39 views

Relationship between FDA Agencies and the Advisory Committee

This article has the following descriptions; "Perhaps what is most surprising is that in mid-August, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 1 to recommend the drug for ...
0
votes
1answer
50 views

How to find FDA's and EMA's review reports and related minutes

Lately, I've been thinking about how we can't make various decisions without going back to what data and the logic behind the drug's approval. I'd like to ask a question about how to search such ...
7
votes
1answer
88 views

Is this study stating red algae reduces cold virus by 92% believable?

I was using this spray meant to hasten recovery from the common cold. This study, sponsored by the pharmaceutical company that produces the spray, stated it reduced virus by 92%, and so shortens the ...
1
vote
1answer
90 views

The process of drug approval; The flow from R&D, planning a clinical trial to drug approval, or other additional process

I'd like to know the process of drug approval; the flow from R&D, planning a clinical trial to drug approval, or other additional process. As far as I am aware, some documents provide too much detail ...
0
votes
1answer
45 views

Progress of the FDA's review of RMAT products

The U.S. FDA appears to have five shortcut regulatory approval ways, as follows; (1) Accelerated Approval (2) Priority Review (3) Fast Track (4) Breakthrough Therapy (5) RMAT:Regenerative Medicine ...
4
votes
1answer
111 views

Are there scientific studies that support the daily usage of xylitol to prevent oral problems?

Since more than 2 years I'm consuming birch sugar (xylitol) instead of sugar for basically everything and I try to avoid any product which contains sugar. Note that I wasn't consuming too many things ...
3
votes
1answer
57 views

Are these studies about red algae reducing cold virus by 92% believable? [duplicate]

I was using this spray meant to hasten recovery from the common cold. A study [1], sponsored by the pharmaceutical company that produces the spray, stated it reduced virus by 92% (this value only ...
0
votes
1answer
52 views

Would neurons regenerate even in adults? [closed]

I want to know whether or not the nerves regenerate in human adults. My Question Please give me evidences for this issue. What experiments and logic do they use to prove that the nerves are/are not ...