tag:blogger.com,1999:blog-3609683919099708226.post7557570769507912219..comments2023-06-16T09:39:07.504-04:00Comments on Harpocrates Speaks: Paying to VolunteerTodd W.http://www.blogger.com/profile/16192694127268195554noreply@blogger.comBlogger5125tag:blogger.com,1999:blog-3609683919099708226.post-43198653909696221252012-06-20T03:21:20.168-04:002012-06-20T03:21:20.168-04:00Phase 2 trials are normally divided into 2a for pr...Phase 2 trials are normally divided into 2a for proof of concept (does the drug work as predicted by non-clinical studies?), and 2b (what dose works best?). So they do test efficacy, but not necessarily in a population that reflects normal clinical practice. What baffles me is why the FDA has approved protocols that don't meet the design requirements of phase 2 - Burzynski's studies can't possibly test efficacy. See http://majikthyse.wordpress.com/2012/04/25/is-the-fda-protecting-burzynski/Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-3609683919099708226.post-29618874963380143662011-12-01T18:50:36.750-05:002011-12-01T18:50:36.750-05:00@Andwhynot
@K77 is correct. You don't need to...@Andwhynot<br /><br />@K77 is correct. You don't need to wait until all of the subjects you need are enrolled. Once the study is approved by an IRB, you can begin enrolling subjects. As K77 mentioned, one of the problems that may occur to stop a trial early are slower than expected enrollment. The protocol should have some plan to deal with poor enrollment, drop-outs and early terminations. In something like Burzynski's trials, I would expect something like an intent to treat (ITT) analysis, where all subjects enrolled are counted in the final analysis. But, from a couple of the earlier published studies I've seen, that doesn't seem to be the case, since early terminations were dropped from analysis completely. One wonders the reasons.<br /><br />Looking at ClinicalTrials.gov, Burzynski has 61 studies registered, only one of which was completed. There are a couple terminations due to slow enrollment, some withdrawn before enrollment began, and a whole lot of studies that have unknown status (no updates in the last two years). That's kinda fishy as well.Todd W.https://www.blogger.com/profile/16192694127268195554noreply@blogger.comtag:blogger.com,1999:blog-3609683919099708226.post-73612371949719252252011-12-01T18:31:38.467-05:002011-12-01T18:31:38.467-05:00@Andwhynot - that's not really how clinical tr...@Andwhynot - that's not really how clinical trials work, certainly based on what I know of cancer trials in the UK. Patients are recruited onto the trial as and when they turn up, treated according to the protocol and followed up. So early recruits will still be treated according to the protocol, exactly the same as later ones. Each person is a unique dataset.<br /><br />If a trial fails to recruit enough people over time, the funding body may close the trial early, and the researchers just have to make do with he data they have up until that point. The reasons trials fail to recruit can be many and varied - not enough suitable patients diagnosed with that type of cancer for example.<br /><br />Trials need to be big enough to be statistically powerful. For larger trials, quite a lot of time will go into calculating how many people are needed to get meaningful results for that particular disease.<br /><br />The main issuem, as I mention above, is that Burzynski claims to have treated 2,000 people over the past 10 years. Where the f*ck is this data? And is it enough to justify charging $$$$ for the current trialK77https://www.blogger.com/profile/14717594968037846003noreply@blogger.comtag:blogger.com,1999:blog-3609683919099708226.post-14596068913093830702011-12-01T14:18:17.013-05:002011-12-01T14:18:17.013-05:00This also raises the interesting question of the s...This also raises the interesting question of the size of Burzynski's trials, and the consequent total gross income therefrom. <br /><br />Clearly, a trial with one subject cannot be in any way randomised, or capable of any form of statistical analysis. So presumably any legitimate trial would have to assemble a cohort of appropriate subjects before commencing, rather than, as seems to be the case, recruiting as and when subjects appear and/or come up with the cash. And if there is a defined size for a particular trial, what happens to early recruits while waiting for the study group to come up to size, particularly if they have terminal conditions?<br /><br />Which raises the question of the income generated. With charges of up to £200,000 per subject, trials involving single figures of subject numbers may be raising 7-figure sums. Are there any actual figures for this?Andwhynothttps://www.blogger.com/profile/04445151795352493151noreply@blogger.comtag:blogger.com,1999:blog-3609683919099708226.post-30428303681544019192011-12-01T13:16:23.475-05:002011-12-01T13:16:23.475-05:00All the trials Dr B is running are phase 2 - these...All the trials Dr B is running are phase 2 - these are not necessarily randomised.<br /><a href="http://cancerhelp.cancerresearchuk.org/trials/types-of-trials/phase-1-2-3-and-4-trials#phase2" rel="nofollow">CancerHelp UK says</a>;<br />Not all treatments tested in a phase 1 trial make it to a phase 2 trial. Phase 2 is sometimes written as phase II. These trials may be for people who all have the same type of cancer, or who have several different types of cancer. Phase 2 trials aim to find out<br /><br /> * If the new treatment works well enough to test in a larger phase 3 trial<br /> * Which types of cancer the treatment works for<br /> * More about side effects and how to manage them<br /> * More about the best dose to use<br /><br />Although these treatments have been tested in phase 1 trials, you may still have side effects that the doctors don't know about. Drugs can affect people in different ways.<br /><br />Phase 2 trials are often larger than phase 1. There may be up to 100 or so people taking part. Sometimes in a phase 2 trial, a new treatment is compared with another treatment already in use, or with a dummy drug (placebo). If the results of phase 2 trials show that a new treatment may be as good as existing treatment, or better, it then moves into phase 3.<br /><br />>>>><br />So you're looking for dosage, toxicity and any inklings of efficacy. The trials aren't actually designed to show true efficacy - you need phase 3 for that. After 2,000 patients treated in the past 10 years (according to the clinic website) you have to ask why he doesn't have enough data to show that he is ready for phase 3. <br /><br />There is one phase 3 trial meant to be starting this year. But the paucity of convincing data after so many years of trials is rather suspicious. If there was significant evidence of efficacy (assuming his methodology is capable of showing it, which is highly doubtful based on previous criticisms of his trials <a href="http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5" rel="nofollow">http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5</a>) then he could licence it to a pharma company (or even set up his own) and make $$$$$$$$$. <br /><br />As he hasn't, one can only ask questions as to why. And at the prices that his clinic is charging to take part in the trials (although he doesn't charge for the actual drug, he charges for pretty much everything else around it), there is a fairly obvious answer. <br /><br />Incidentally, I wonder how many of his success stories are actually down to chemotherapy? <a href="http://www.burzynskiclinic.com/treatment-options.html" rel="nofollow">http://www.burzynskiclinic.com/treatment-options.html</a>K77https://www.blogger.com/profile/14717594968037846003noreply@blogger.com