Posted On: 12/03/2015 11:02:26 PM
Post# of 72443
Apparently so.
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Question about a regulation in Clinical Trials
(05/19/2004)
Question 1:
This question pertains generally to regulations in Clinical Trials. It pertains specifically to availability of blinded data after an individual has completed the trial but before unblinding of the trial's data.
Question: Does a company performing a doubly-blinded pivotal Phase Three Clinical Trial have access to BLINDED participant's data AFTER a participant has completed/exited the trial, but BEFORE the trial is unblinded?
Example: Let us assume that a biotech company is performing a clinical trial. The trial is a normal double-blinded Phase Three pivotal trial. In the trial in question, patients are enrolled for a surgical procedure and given a putative drug or placebo at the time of the surgery, and then evaluated at six-months following the surgery. Once the six-month evaluation has been completed, the patient has completed all trial requirements and exits the trial. Let us assume that patients/participants are enrolled at approximately one per day for several years. As would be expected, upon completion of the final patient's six-month evaluation, the complete data set is vetted for correctness, and then unblinded to determine the trial's results.
However, does the biotech company have access to the completion record of each individual patient after they have completed the trial, but before the trial is unblinded? This is with the understanding that the unblinding key remains unknown to all until the trial is ready to become unblinded. That is, does the biotech company have access to a patient's BLINDED data after that individual patient has exited the trial?
Answer 1:
Companies commonly do have such access, but it is recognized that even these blinded data may provide information that sponsors might inappropriately use to make changes in the trial.
FDA's regulations don't prohibit this, but before sponsors access such data they should consider whether such information might be considered to potentially bias their further conduct of the trial."
http://firstclinical.com/fda-gcp/?show=RE+sta...amp;page=1
"
Question about a regulation in Clinical Trials
(05/19/2004)
Question 1:
This question pertains generally to regulations in Clinical Trials. It pertains specifically to availability of blinded data after an individual has completed the trial but before unblinding of the trial's data.
Question: Does a company performing a doubly-blinded pivotal Phase Three Clinical Trial have access to BLINDED participant's data AFTER a participant has completed/exited the trial, but BEFORE the trial is unblinded?
Example: Let us assume that a biotech company is performing a clinical trial. The trial is a normal double-blinded Phase Three pivotal trial. In the trial in question, patients are enrolled for a surgical procedure and given a putative drug or placebo at the time of the surgery, and then evaluated at six-months following the surgery. Once the six-month evaluation has been completed, the patient has completed all trial requirements and exits the trial. Let us assume that patients/participants are enrolled at approximately one per day for several years. As would be expected, upon completion of the final patient's six-month evaluation, the complete data set is vetted for correctness, and then unblinded to determine the trial's results.
However, does the biotech company have access to the completion record of each individual patient after they have completed the trial, but before the trial is unblinded? This is with the understanding that the unblinding key remains unknown to all until the trial is ready to become unblinded. That is, does the biotech company have access to a patient's BLINDED data after that individual patient has exited the trial?
Answer 1:
Companies commonly do have such access, but it is recognized that even these blinded data may provide information that sponsors might inappropriately use to make changes in the trial.
FDA's regulations don't prohibit this, but before sponsors access such data they should consider whether such information might be considered to potentially bias their further conduct of the trial."
http://firstclinical.com/fda-gcp/?show=RE+sta...amp;page=1
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