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Session 1 Background and Legislative Requirements

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Title: Session 1 Background and Legislative Requirements


1
Session 1Background and Legislative Requirements
2
ClinicalTrials.gov Background
  • Dr. Deborah A. Zarin

3
ClinicalTrials.gov Team
Jerry Sheehan
Betsy Humphreys
  • Director
  • Deborah Zarin
  • Project Leads
  • Annice Bergeris
  • Nicholas Ide
  • Alison Robbins
  • Tony Tse
  • Rebecca Williams
  • Quality Assurance
  • John Frye
  • Cherryl Macalintal
  • Alex Valentine
  • Systems Development
  • Jane Fun
  • John Gillen
  • Alex Kostyukovsky
  • Russell Loane
  • Allison Yu
  • Domain Expert
  • William Harlan
  • Administration
  • Tamia Whitfield

4
Ethical and Scientific Rationale for Increased
Clinical Trial Transparency
  • Subjects put themselves at risk
  • Subjects right to be informed
  • All available options, including ongoing trials
  • Previous research, including completed trials
  • Avoid redundant trials
  • Support Evidenced-Based Medicine (EBM)
  • Detect reporting problems
  • Lack of publication
  • Unexplained changes to protocol

5
Recent Events Lack of Transparency in Clinical
Research
6
Source Figure 1A. Turner et al. (NEJM, 2008)
7
The investigation was launched following concerns
  • although the ENHANCE trial ended in April 2006,
    the data had not yet been released.
  • the sponsors did not register the clinical
    trial in a timely manner.
  • the sponsors attempted to change the study
    endpoints, and thus the study results, prior to
    the public release of the results.

8
Source Silverstein FE et al. JAMA. 2000 Sep
13284(10)1247-55.
9
Kaplan-Meier estimates for ulcer complications
according to traditional definition. Results are
truncated after 12 months, no ulcer complications
occurred after this period. Adapted from Lu 2001.
Source Jüni P, Rutjes AW, Dieppe PA. BMJ. 2002
Jun 1324(7349)1287-8.
10
ClinicalTrials.gov
  • Prospective registry
  • Interventional and observational trials
  • Approved by IRB (or equivalent)
  • Conform to regulations of national health
    authorities
  • All sponsor types
  • All intervention types
  • Summary of key protocol items
  • Consistent with ICMJE and WHO
  • Links to publications, other info
  • Does not include unpublished results

11
Policies and Users
Ottawa Statement
Sponsor Policy (e.g., NIH, VA)
PL 110-85
ICMJE
Maine
FDAMA 113 BPCA
WHO
ClinicalTrials.gov
Recruitment (e.g., patients, physicians)
Health Policy Makers
Systematic Reviewers
Journal Editors
Research Funders
12
International Registries and Number of Trials
(as of 2/4/08)
ClinicalTrials.gov 50,564
ISRCTN (UK) 6,514
Australian New Zealand Clinical Trial Registry (ANZCTR) 1,973
Netherlands Trial Registry 1,111
UMIN Clinical Trials Registry (Japan) 943
Chinese Clinical Trial Register (ChiCTR) 34
Clinical Trials Registry India (CTRI) 16
13
Characteristics of ClinicalTrials.gov
  • Web-based registration system (PRS)
  • Register through organizational accounts
  • Key part of validation
  • XML data upload (lt20 records)
  • Data are dynamicdata provider can modify data
    at any time
  • Changes are tracked

14
Homepage - ClinicalTrials.gov
15
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16
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17
http//ClinicalTrials.gov/archive
18
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19
ClinicalTrials.gov General Statistics
20
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21
ClinicalTrials.gov Statistics(as of 2/4/2008)
  • Number Percent
  • Total 50,564 100
  • Type of Trial
  • Observational 7,701 15
  • Interventional 42,836 85
  • Drug Biologic 32,835
  • Surgical Procedure 10,856
  • Behavioral, Gene
  • Transfer, Other 4,809
  • Device 2,628
  • International Sites
  • US only 25,485 50
  • Non-US only 15,982 32
  • US Non-US mixed 3,934 8
  • Missing 5,163 10

27 records missing Study Type information
21
22
ClinicalTrials.gov Statistics Cont.(as of
2/4/2008)
Number Percent
Trials by Data Provider US Federal (including
NIH) 16,430 33 University, other 19,803
39 Industry 14,331 28
User Statistics Page Views per month 20
Million Unique visitors per month 500,000
22
23
Organizational Accounts
  • Total            4,792  
  • Fed accounts   71
  • NIH accounts   26
  • Industry           1,783
  • Other               2,912
  •         

24
Validation of Data for Registry
  • Issues
  • Quality Assurance Are the entries as accurate
    and informative as possible?
  • Validation (w/o access to protocols) Is the
    fundamental information true?
  • QA Process at ClinicalTrials.gov
  • System of automated and manual checks
  • Staff works with data provider to correct/improve
    records
  • Links inserted

25
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26
ENHANCE
2
1
3
Source Kastelein JJ, Sager PT, de Groot E,
Veltri E. Am Heart J. 2005 Feb149(2)234-9.
27
  • Primary Outcome Measures
  • Change in ultrasound-determined average carotid
    artery intima-media thickness (IMT) on a per
    subject basis between baseline and endpoint.
     Time Frame 24 months 
  • Primary Outcome Measures
  • Change in ultrasound-determined average carotid
    artery intima-media thickness (IMT) on a per
    subject basis between baseline and endpoint.
     Time Frame 24 months 

28
Legislative RequirementsJerry Sheehan
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