tag:blogger.com,1999:blog-15654301.post7936264859681105520..comments2024-02-24T04:43:56.829-05:00Comments on On Biostatistics and Clinical Trials: Is it time to change the clinical monitoring practice in clinical trials?Web blog from Dr. Denghttp://www.blogger.com/profile/11917138094035874938noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-15654301.post-26833688818869467222011-09-14T13:00:19.192-04:002011-09-14T13:00:19.192-04:00During DIA conference, one officer from BIMO (BIor...During DIA conference, one officer from BIMO (BIoresearch MOnitoring program) in FDA stated that FDA will require the sponsor to provide an analysis data set containing the site-level summary results (for example the treatment difference for each site). This data set will facilitate the agency to identify any outliers or any issues for auditing. This request is in line with FDA's position "Prioritization of Clinical Trial Inspections" as indicated in their website. <br /><br />http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm226306.htm<br /><br />"Prioritization of Clinical Trial Inspections. FDA Centers are developing new approaches for improving the process for selecting clinical investigators and other entities for inspection, both at the pre-approval stage and earlier in the product development process. The Center for Drug Evaluation and Research (CDER) is piloting a tool that uses a sponsor-submitted clinical analysis dataset and assesses clinical sites associated with an application for inspection using a risk-based prioritization process model. This tool also has automated features to streamline the inspection request process, and is expected to provide a more efficient, analytical, and timely approach to clinical site inspection and site monitoring. Similarly, the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) have early intervention programs whereby ongoing studies are identified for inspection using risk-based criteria. "<br /><br />However, this request will add additional burden to the sponsor side and the request data set may not be very useful if the # of subjects at each site is small. <br /><br />CBER representative later clarified that this request for site-level summary data set was only for CDER division.Web blog from Dr. Denghttps://www.blogger.com/profile/11917138094035874938noreply@blogger.comtag:blogger.com,1999:blog-15654301.post-64491719394689507672011-09-14T11:29:55.693-04:002011-09-14T11:29:55.693-04:00I agree that more statisticians will be necessary ...I agree that more statisticians will be necessary in monitoring clinical trials. This is not only necessary for centralized monitoring, but also for what FDA has been calling, "compliance monitoring." This can mean looking at different trends to determine if data outliers indicate research misconduct or serious noncompliance. I am convinced that biostatisticians at FDA find as much fraud as the inspectors, if not more.Carl Anderosnhttp://carl1anderson.wordpress.com/2011/09/04/fda-releases-draft-guidance-for-monitoring-clinical-trials/noreply@blogger.com