Replies to post #160946 on Cytodyn Inc (CYDY)

[misiu143]

I did myself some trials , but obviously not enough in your opinion to know.
FDA must approve everything in a trial , and this is the biggest thing..

When they advise and approved our trial for 50 patients in HIV combo, doctors in 38 hospitals and clinics treating HIV patients couldn't enroll 50 patients for 2 years ,

--This may only happen when disease is very rare ,
--or protocol very bad.

And HIV is not a very rare disease.

2 years later FDA changed the protocol and patients were enrolled , but 2 years were lost .

All IMO.

[CTMedic]

hotmeat,

Just completely and utterly false.

'nuff said.

The FDA HAS NOTHING TO DO WITH CONDUCTING TRIALS

[masshysteria]

hotmeat - your statements regarding the roles of DMC /DSMB are inaccurate and incorrect.

For factual information about the role the committee and the FDA - please read the following: Guidance for Clinical Trial Sponsors

I'm sure there are plenty of people on this board with actual experience on the subject matter who can shed light on anything that may be difficult to understand or is ripe for a lively discussion or perspective.

As an overview...

No - the DSMB:
Does not decide anything. They monitor and recommend.

Yes - the FDA is highly involved in trial design and review of DSMB updates and recommendations

Yes - only the FDA or the sponsor can stop a trial based on findings or recommendations

One little tidbit from the document - but there are 38 pages well worth reading;

"7.3. DMC Recommendations for Protocol Changes
A DMC may, in some instances, recommend changes to the study protocol, particularly
in the context of their responsibilities for monitoring patient safety. Many protocol
changes have little impact on the usefulness of a trial to gain regulatory approval. Certain
types of changes to the protocol, however, such as changes in the primary endpoints,
could have substantial impact on the validity of the trial and/or its ability to support the
desired regulatory decision if they potentially could have been motivated by the interim
data. We recommend that sponsors discuss proposed changes of the latter type with FDA
before implementation."

Because the FDA's guidelines and documentation are as fluid and interpretive as they come, it allows the FDA to approve a trial based on an initial design, and change goal posts afterwards based on an infinite number of possible scenarios. This happens time and time again and is an iterative dance performed over history and shall forever repeat itself so long as drug development remains the difficult, always evolving and non-exact science that it is.

MH