LEADER 04408nam 2200637Ia 450 001 9910956689703321 005 20251017110056.0 010 $a0-309-18054-6 010 $a1-280-50667-9 010 $a9786610506675 010 $a0-309-65577-3 035 $a(CKB)1000000000465560 035 $a(EBL)3378103 035 $a(SSID)ssj0000137676 035 $a(PQKBManifestationID)11158795 035 $a(PQKBTitleCode)TC0000137676 035 $a(PQKBWorkID)10088602 035 $a(PQKB)10195975 035 $a(MiAaPQ)EBC3378103 035 $a(Au-PeEL)EBL3378103 035 $a(CaPaEBR)ebr10132071 035 $a(CaONFJC)MIL50667 035 $a(OCoLC)923275635 035 $a(DNLM)1284382 035 $a(BIP)53855458 035 $a(BIP)13425437 035 $a(EXLCZ)991000000000465560 100 $a20060809d2006 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aDeveloping a national registry of pharmacologic and biologic clinical trials $eworkshop report /$fCommittee on Clinical Trial Registries, Board on Health Sciences Policy, Institute of Medicine of the National Academies 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$dc2006 215 $a1 online resource (124 p.) 300 $aDescription based upon print version of record. 311 08$a0-309-10078-X 320 $aIncludes bibliographical references (p. 47-48). 327 $a""Front Matter""; ""Independent Report Reviewers ""; ""Foreword ""; ""Preface ""; ""Contents ""; ""List of Tables ""; ""1 Summary ""; ""2 The Need for Clinical Trial Registries ""; ""3 Current Registry Activities ""; ""4 Content of a Clinical Trial Registry ""; ""5 Implementation Issues ""; ""6 Conclusion and Next Steps ""; ""References ""; ""APPENDIXES""; ""A Participants and Invited Experts Between December 1, 2004, and June 27, 2005 ""; ""B Workshop Agenda, Speakers, Panelists, and Participants: June 27, 2005 "" 327 $a""C Section 113 of the Food and Drug Administration Modernization Act of 1997 and Guidance for Industry: Information Programs on Clinical Trials for Serious or Life- Threatening Diseases and Conditions. U.S. Department of Health and Human Services.""""D Published Journal Editorials ""; ""E Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases""; ""F Illustrative Data Fields for the Results Summary (based on ICH E3 template) ""; ""G Biographical Sketches of Committee Members "" 330 $aTo improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent registry of relevant information on clinical trials for drugs and biologics. The public and various entities within the medical community (health care providers, researchers, medical journal editors, pharmaceutical companies, health insurers, and regulators) have different expectations and perceived needs regarding a public clinical trial registry. The IOM Committee on Clinical Trial Registries hosted a workshop on June 27, 2005, to obtain much-needed input from members of the public, public advocate groups, and the broader community of journal editors, pharmaceutical and biotech leaders, NIH, and the FDA. Participants discussed the data elements that have been at the core of debate and commented on issues of compliance and implementation of a national clinical trial registry. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report inlcudes discussions at the workshop centered on the following five concepts, and are described within this report: 1) Purpose, 2) Which Trials to Include, 3) Delayed Disclosure Mechanism, 4) Reporting Results of Completed Trials, and 5) Compliance. 606 $aClinical trials$zUnited States 606 $aClinical medicine$xResearch 615 0$aClinical trials 615 0$aClinical medicine$xResearch. 676 $a615.5072 712 02$aInstitute of Medicine (U.S.).$bCommittee on Clinical Trial Registries. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910956689703321 996 $aDeveloping a national registry of pharmacologic and biologic clinical trials$94446601 997 $aUNINA