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December 31, 2012 at 11:13 pm #20891ksg1111Participant
Question re trials for former participants. How is information handled during a trial? I know they are regularly doing scans etc. to evaluate the success of the meds.
Are they sharing the results of scans and other tests with you immediately or are they not able to share because that might skew the trial results esults in some way?
How about partial success when results are ok, but not as good as you might expect from standard meds or a different trial? And, do the rules vary for various phases, or various centers?
Thank you in advance for any information you can provide.December 31, 2012 at 11:58 pm #58286Catherine PooleKeymaster
A legitimate trial coordinator will make sure your scan results and progress is reported to you directly. I will check with an expert, but there shouldn’t be any descrepancies in how information is handled. The only time there are any “secrets” are when the trial is blinded to all, no one know who has what therapy. But I will dig a little further.January 1, 2013 at 9:16 pm #58287PhillyRedParticipant Regarding information gathered during a trial: A patient’s own laboratory results and imaging results collected for safety monitoring during the course of a trial are generally shared with the study patient during their participation in the trial, eg, things like abnormal hematology (blood counts) and clinical chemistry tests (including things like electrolytes, blood sugar, liver enzymes). Imaging scans are usually performed at pre-treatment baseline, after every couple of courses of study treatment, and when the patient comes off-study. The patient will be told the results of the scan (if the patient has a complete or partial response to study treatment, or if their disease remains stable, or if the scans show progression of the cancer) at the time following the scan. If the scan shows a response or disease stabilization, the patient will be given the option of remaining on the study; if the scan shows disease progression, the patient will be removed from the study (with one exception; with some immunotherapies, the patient may initially experience disease progression, followed by a delayed immune response; in that case, the patient may not be taken off the study right away, until the immune system has a chance to work).
Results of additional laboratory studies designed to learn more about the efficacy of the study drug may not be immediately available to the study participants for a couple of reasons, these tests may not be run immediately; often they are collected, frozen, and run in batches once they collect enough samples; in addition, they study may be blinded and not immediately known what treatment the patient has received (so, the effects of the study drug are not yet known); also, a statistical evaluation of the results may not be able to be performed until enough samples are collected and run, so as to give a meaningful and significant sample size.
Large, later stage (ie, Phase 2 and Phase 3, and occasionally large Phase 1) trials will usually have built into the trial, an interim data analysis, following enrollment and treatment of half or more of the trial’s expected participants. The interim statistical analysis will determine if there is an indication that the drug is showing efficacy; if there is no indication of efficacy and there are unacceptable side effects, the trial may be stopped early; otherwise, it will continue as planned. The results of an interim analysis usually are not shared with the study participants. The outcome of a trial may only be disclosed to the participants after the trial has been completed and the final data analysis has been performed. And in large randomized, controlled blinded trials (eg, Phase 3 and some Phase 2 studies), the efficacy of the study drug will only be revealed once the study is completed, the database containing all study data is locked (meaning the all data is collected and cannot be altered or revised), and the study is then unblinded to reveal who got the study drug and who got a comparator drug (standard of care drug) and a final statistical analysis of the study treatments is performed.
A study drug does not always have to show superiority to an existing standard of care drug in order for it to receive FDA approval, but it does have to indicate that the benefits of taking the study drug outweigh the potential risks of taking it.
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