tag:blogger.com,1999:blog-15654301.post1039169563497950905..comments2024-02-24T04:43:56.829-05:00Comments on On Biostatistics and Clinical Trials: Transparency - a change about drug approval information on FDA's websiteWeb blog from Dr. Denghttp://www.blogger.com/profile/11917138094035874938noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-15654301.post-25513281982960188912011-01-06T11:30:51.332-05:002011-01-06T11:30:51.332-05:00I would like to add here that Statistics section i...I would like to add here that Statistics section in NIH funded research protocol is now being summarized in the section called Research Strategy. The role of Statistics and statistician now is more apt to be labelled as that of Research Methodologist- comprising of not just the statistical tools, but also. Design, ethics, and every thing else involved with research coordination. Much of outright dislike for statistics in Biomedical research is a result of a lack of fundamental understanding of what statistics really is as a science as well as an art particularly as it applies to clinical research settings.please Check papers by Steven<br /> Goodman of John Hopkins. ThanksRakesh shuklacnoreply@blogger.comtag:blogger.com,1999:blog-15654301.post-13558017854088232192010-09-02T05:41:46.504-04:002010-09-02T05:41:46.504-04:00I don't think you can omit the statistics sect...I don't think you can omit the statistics section from the protocol. The protocol is also for regulatory agencies and EC/IRB. They need to assess whether or not the statistical analysis for study endpoints (especially the primary endpoint) is adequate. With the public demanding more transparency in conducting the clinical trials, this is more critical than ever. The statistics section in the protocol defines the pre-specified analyses to prevent the people from doing the analyses purely post-hoc or data driven.<br /><br />My understanding is the statistics section should be concise in the protocol and the SAP will provide the details.Web blog from Dr. Denghttps://www.blogger.com/profile/11917138094035874938noreply@blogger.comtag:blogger.com,1999:blog-15654301.post-45471043188684385362010-09-01T11:21:03.882-04:002010-09-01T11:21:03.882-04:00Dear Mr. Chunquin, thank you for such an interesti...Dear Mr. Chunquin, thank you for such an interesting and clear blog, it's pleasure to read it! I am a Spanish Translator specialized in translating Medical Protocols (I will be lecturing in NY on October 2nd) and I would like to know your opinion about the need of the statistics section in the protocols. Is it necessary? Does anyone involved (patient, physician, investigator) understand it? I think that information should remain in the SAP. Regards from Valladolid, Spainparatterminarhttps://www.blogger.com/profile/00668446590099033413noreply@blogger.com