MONITORING THE VALUE OF TRIAL REGISTER INFORMATION

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MONITORING THE VALUE OF TRIAL REGISTER INFORMATION

• Thomson Pharmaceutical Services
• LAWRENCE LIBERTI MS, RPh, RAC
• JULY 16, 2008

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SCOPE OF TODAYS PRESENTATION

• PRACTICAL ROLE OF REGISTERS
• FORMATS OF REGISTER PRESENTATION
• METHODS TO ASSESS ONLINE REGISTER INFORMATION
• DETERMINING THE VALUE OF REGISTERS TO TARGET
  USERS
• CONCLUSIONS

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REGISTER vs REGISTRY?
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WHATS IN A NAME?

• Registry A repository of ongoing clinical trials
• www.clinicaltrials.gov
• Clinical Trial Registry Data Bank (FDAAA)
• Register A repository for the results of
  clinical trials
• www.clinicalstudyresults.org
• Results Data Bank (FDAAA)

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THE PRACTICAL ROLE OF REGISTRIES and REGISTERS
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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

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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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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)

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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)

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FORMATS OF PRESENTATIONSStudy ListingsResults
Postings
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STUDY LISTINGS (www.clinicaltrials.gov)

• ClinicalTrials.gov currently has 58,702 trials
  with locations in 157 countries

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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.

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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

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WYETH-SPONSORED STUDY
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GSK APPROACH TO SUMMARY FORMATS
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AVANDIA P-1 ONLINE REPORT (GSK)
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No Conclusions
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LILLY-SPONSORED STUDY
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METHODS TO ASSESS REGISTER INFORMATION
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METHODS TO ASSESS REGISTER INFORMATION
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METHODS TO ASSESS REGISTER INFORMATION
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DETERMINING THE VALUE OF REGISTERS TO TARGET USERS
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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?

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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 gt 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.

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THE UAB STUDY RESULTS

• How much time do you spend reading scientific
  literature each week?
• 1-2 hrs 30
• 3-4 hrs 35
• 5-6 hrs 15
• 6-8 hrs 10
• gt8 hrs 10
• 65 spent up to 4 hrs reading literature

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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

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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

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HOW CAN THOMSON REUTERS HELP?

• Custom information solutions
• Regulatory support
• Decision-making support
• Database development
• Content/editorial support

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COMPETITORS?

• TrialTrove (www.citeline.com)
• ADIS Clinical Trials Insight
• Espicom Pharma Med Device News
• FDA News Drug Pipeline Alert
• IMS RD Focus, New Drugs
• IDIS InPharma
• NewsRx
• PHIND
• PROMT
• Prous Daily Essentials
• Scrip

• Controlledtrials.com
• The Clinical Trial Registry Platform
  (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.