Transcript THOMSON REUTERS PRESENTATION TEMPLATE

MONITORING THE VALUE OF TRIAL
REGISTER INFORMATION
Thomson Pharmaceutical Services
LAWRENCE LIBERTI MS, RPh, RAC
JULY 16, 2008
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
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REGISTER vs REGISTRY?
WHAT’S 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
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 FDAapproved 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
PRESENTATIONS
Study Listings
Results Postings
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 studyderived 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
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
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 > 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%
>8 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)
• Controlledtrials.com
• ADIS Clinical Trials Insight
• The Clinical Trial Registry
Platform (www.who.int/ictrp/en)
• Espicom Pharma & Med
Device News
• FDA News: Drug Pipeline Alert
• Centerwatch
(centerwatch.com)
• IMS R&D Focus, New Drugs
• IDIS InPharma
• NewsRx
• PHIND
• PROMT
• Prous Daily Essentials
• Scrip
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.
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