1. MONITORING THE VALUE OF TRIAL REGISTER INFORMATION Thomson Pharmaceutical Services LAWRENCE LIBERTI MS, RPh, RAC JULY 16, 2008

2. 2 SCOPE OF TODAY’S PRESENTATION PRACTICAL ROLE OF REGISTERS FORMATS OF REGISTER PRESENTATION METHODS TO ASSESS ONLINE REGISTER INFORMATION DETERMINING THE VALUE OF REGISTERS TO TARGET USERS CONCLUSIONS

3. REGISTER vs REGISTRY?

4. 4 WHAT’S IN A NAME? Registry: A repository of ongoing clinical trials –www.clinicaltrials.govwww.clinicaltrials.gov –“Clinical Trial Registry Data Bank” (FDAAA) Register: A repository for the results of clinical trials –www.clinicalstudyresults.orgwww.clinicalstudyresults.org –“Results Data Bank” (FDAAA)

5. THE PRACTICAL ROLE OF REGISTRIES and REGISTERS

6. 6 REGULATORY INITIATIVES State Bills (to amend the PHS Act to expand the clinical trials drug data bank) *******FDAAA September 2008 Title VIII- Clinical Trial Databases********

7. 7 The Maine Precedent Maine law requires manufacturers or labelers of prescription drugs to list information on clinical trials on prescription drugs that have been FDA- approved for marketing and are (or have been) dispensed, administered, delivered or promoted in Maine. Certain registration and results information must be posted on clinical trials conducted or sponsored by the manufacturer on or after October 15, 2002. The date by which the information must be posted varies depending on when the trial occurred and when the drug first enters Maine. An Act Regarding Advertising by Drug Manufacturers and Disclosure of Clinical Trials

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9. 9 THE PRACTICAL ROLE OF REGISTRIES For federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. (Sponsored by US National Institutes of Health)

10. 10 THE PRACTICAL ROLE OF REGISTERS The ClinicalStudyResults.org site is a central, widely accessible, web-based repository for clinical study results in a reader-friendly, standardized format. This database will serve the valuable function of making clinical trial results for many marketed pharmaceuticals more transparent. More importantly, it is designed as a key tool to provide information to practicing physicians and their patients. (Sponsored by PhRMA)

11. FORMATS OF PRESENTATIONS Study Listings Results Postings

12. 12 STUDY LISTINGS (www.clinicaltrials.gov)www.clinicaltrials.gov ClinicalTrials.gov currently has 58,702 trials with locations in 157 countries

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15. 15 RESULTS POSTINGS Welcome to ClinicalStudyResults.org! The ClinicalStudyResults.org site is a central, widely accessible, web-based repository for clinical study results in a reader-friendly, standardized format. This database will serve the valuable function of making clinical trial results for many marketed pharmaceuticals more transparent. More importantly, it is designed as a key tool to provide information to practicing physicians and their patients.

16. 16 SUMMARY OF THE ROLE OF RESULTS POSTINGS To provide a repository of information To provide a balanced overview of clinical study- derived information To comply with regulatory requirements NOT intended to promote off-label uses NOT intended to provide conclusions

17. 17 WYETH-SPONSORED STUDY

18. 18 GSK APPROACH TO SUMMARY FORMATS

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21. 21 AVANDIA P-1 ONLINE REPORT (GSK)

22. 22 No Conclusions

23. 23 LILLY-SPONSORED STUDY

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27. METHODS TO ASSESS REGISTER INFORMATION

28. 28 METHODS TO ASSESS REGISTER INFORMATION

29. 29 METHODS TO ASSESS REGISTER INFORMATION

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31. DETERMINING THE VALUE OF REGISTERS TO TARGET USERS

32. 32 DETERMINING THE VALUE OF REGISTERS TO TARGET USERS RAISES MANY QUESTIONS How will health professionals use register information? –As a primary source of data? –As a back-up to published data How will consumers use the information? What will drive users to registers? What will users remember from registers? Will register data impact knowledge and drug use?

33. 33 UAB STUDY RESULTS Designed to assess how physicians use medical literature to learn about drug therapies CME-accredited program through University of Alabama School of Medicine N = 299 physicians –IM, FP, GP specialties –Urban, suburban, rural practices –1 to > 20 years since medical school Liberti L, Casebeer L, et al: Critical appraisal of medical literature by physicians and its relevance to practice. Presented at the 64th Annual Conference of the American Medical Writers Association, St. Louis, MO, October 2004.

34. 34 THE UAB STUDY RESULTS How much time do you spend reading scientific literature each week? 1-2 hrs30% 3-4 hrs35% 5-6 hrs15% 6-8 hrs10% >8 hrs10% 65% spent up to 4 hrs reading literature

35. 35 CONCLUSIONS Clinicians read in limited time, so information must be positioned: –To a target audience –To have an impact on a thought process –With good information concentrated in specific areas of the article –With clear messages supported by data

36. 36 INFERENCES FOR TRIAL REGISTERS Clinicians have limited time to access and interpret the information Clinicians can distinguish between “solid” and “weak” clinical reports Simplify the data presentation structure, length Provide valid information How can conclusions be drawn without regulatory conflicts? Need to validate new tools to assess the practical value and impact of register information

37. 37 HOW CAN THOMSON REUTERS HELP? –Custom information solutions –Regulatory support –Decision-making support –Database development –Content/editorial support

38. 38 COMPETITORS? TrialTrove (www.citeline.com)www.citeline.com ADIS Clinical Trials Insight Espicom Pharma & Med Device News FDA News: Drug Pipeline Alert IMS R&D Focus, New Drugs IDIS InPharma NewsRx PHIND PROMT Prous Daily Essentials Scrip Controlledtrials.com The Clinical Trial Registry Platform (www.who.int/ictrp/en)www.who.int/ictrp/en Centerwatch (centerwatch.com) Snow B: Previewing clinical trial results online. November 2005 Liberti L et al: In Search of “Clinical Trial register Version 2.0” in Clinical Trial Registries: A practical Guide for Sponsors and Researchers of Medicinal Products.