Monitoring Clinical Trial Data Using an Unblinded Industry Statistician
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Geraldine L. Baggs, PhD Anand S o l , PbD Jeffery S. Oliver,
MS
Wendy M. Jones, MS
193
Monitoring Clinical Trial Data Using an Unblinded Industry Statistician
Linna Liu, MAS, MS Susan M. loth, MPH Abbott Nutrition Research 6. Development, Abbott Laboratories. Columbus, Ohio Key Words Data monitoring committee; Unblinded industry statistician; FDA guidance Correspondence Address Geraldine E. Bags,Abbott Nutrition Research 6. Development, Abbott Laboratories. 625 ClevelandAvenue, Columbus, OH 43215 (email: geraldine.b a g s Qabbott. com). The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The Drug Infmation Assm'ation designates this educational activity for a maximum of I AMA PRA Category 1 Credit(s)TM.Physicians should onh claim credit commensurate with the extent oftheir participation in the activity. lfyou would like to receive a statement ofcredit, you must review the article, and complete the posttest and evaluation included on the DIA website. Participants must receive a passing score of 80%or better on the post-test in order to receive a statement of credit. To access the post-test and evaluation, please visit the DIA website at w.diahome.org. select Educational OjJm'ngs. then select Continuing Educationfiom the drop down menu, and the My Transcript link. 7his will take you to the My Transcript page whereyou will be prompted to sign-in using your DIA usmame and password. Once signed-in,you may select the Monitoring Clinical Trial Data Using An Unblinded Industry Statistician link. You will be prompted to complete the post-test and evaluation. Upon successful completion of the posttest, you will be able to downloadyour statement of credit. lfyou are not a DIA mtomo; please contact the DIA ofice at mytranscript @diahome.orgfor a registmtion form. There is no fee to receiveyour statement of credit. Release Date: March I , 2008 Expiration Date: February 28,2009 Estimated time to complete the activity I hour
The three-statisticianmodd of monitoringdata j b m an ongoing trid genemted strong reactions the statistical community At controversy is the mommendation that an independent statistician serves as unblinded liaison to the data monitoring committee (DMC). We share OUT a p ' e n c e with using an industry statistician us the unblinded liaison in a study on the eady treatment of patent ductus arteriosus in prematureinfants. The DMC membership induded an academic consulting statistician.A
DMC charterwas drawn up layingdown the expectations for committee members. The siu@ statisticians were not invdvd in dealings with the DMC. only the liaison statistician responSiMe for genemting reports and analyses was aware of thegrouped resultsA versus 8. A report generation process was established ensuring a f i r d for maintaining confidentiality of redts.In certain situations, emplyitg an industry statistician as the d i n d e d liaison to the DMC is a viable option for monitoringdata.
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