Replies to post #192262 on Avid Bioservices Inc (CDMO)

[biopharm]

With all due respect, isn't it necessary to take blood/biopsies from the beginning of the clinical trial in order to use them as surrogate endpoints? SK has sad repeatedly they would not be part of the phIII.

Surrogate endpoints become "important" and that is deemed statistically significant I would say, if the FDA or some other group decides that a blood test that measures for "xyz" means you are doing well and may live a long healthy life.

Well... guess what? At that time, those blood tests may begin on "SunRise" for NEW patients entering, as the CURRENT patients already in the trial for 2..3..4..5..6..7..8..9.. months are then given the same blood test for "xyz" and IF the difference is seen, the DMC can halt the trial at that time.

Please don't come back and say the trial can't be modified, because I've already posted a couple times that yes, an FDA trial can be modified by the movement/request of the DMC. Yes, an FDA trial CAN BE MODIFIED by the DMC.

I can dig it up for you if you want... aww, what the hell, here it is making me late for work again today : )

These statements are the opening of Pandoras Box for Big Pharma and Big Pharma has no idea how far Peregrine will go to secure the completion of a trial that should have been FDA approved after phase IIb NSCLC

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Guidance for Clinical Trial Sponsors
Establishment and Operation of Clinical Trial Data Monitoring Committees
Contains Nonbinding Recommendations

4.4.1.4. Consideration of External Data

A DMC may be asked to consider the impact of external information on the study being monitored. Release of results of a related study may have implications for the design of the ongoing study, or even its continuation. In some cases, particularly when unexpected safety issues arise in related studies, the sponsor may bring external data to the attention of the DMC; in other cases, the data may be publicly reported. Such data may lead to recommendations ranging from termination of the study, termination of one or more study arms, changes in target population, dose and/or duration of the intervention, or use of concomitant treatments. The DMC may also recommend changes to the consent form or investigator’s brochure, and/or letters from the sponsor to study participants describing the new results.

The role of the DMC in considering interim changes to a study protocol or other aspects of study conduct in response to external information raises additional issues that merit consideration.
4.4.3. Other Responsibilities

4.4.3.1. Making Recommendations

A fundamental responsibility of a DMC is to make recommendations to the sponsor (and/or, as noted in the Introduction, a steering committee or other group delegated by the sponsor to make decisions about the trial) concerning the continuation of the study. Most frequently, a DMC’s recommendation after an interim review is for the study to continue as designed. Other recommendations that might be made include study termination, study continuation with major or minor modifications, or temporary suspension of enrollment and/or study intervention until some uncertainty is resolved.

Because a DMC’s actions potentially impact the safety of trial participants, it is important that a DMC express its recommendations very clearly to the sponsor. Both a written recommendation and oral communication, with opportunity for questions and discussion, can be valuable. Recommendations for modifications are best accompanied by the minimum amount of data required for the sponsor to make a reasoned decision about the recommendation, and the rationale for such recommendations should be as clear and precise as possible. Sponsors may wish to develop internal procedures to limit the interim data released by a DMC after a recommendation until a decision is made regarding acceptance or rejection of the recommendation, to facilitate maintaining confidentiality of the interim results should the trial continue. We recommend that a DMC document its recommendations, and the rationale for such recommendations, in a form that can be reviewed by the sponsor and then circulated, if and as appropriate, to IRBs, FDA, and/or other interested parties. Sections 5 and 7.2.1 address implications for reporting to FDA of DMC recommendations for major study changes such as early study termination.

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