Home > BOR > Clinical Trials Working Group > Meeting 1
ClinicalTrials.Gov Background
Session 1: Background and Legislative Requirements
ClinicalTrials.gov Background
Dr. Deborah A. Zarin
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
Ethical and Scientific Rationale for Increased Clinical Trial Transparency
- Subjects put themselves at risk
- Subject’s 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
Recent Events: Lack of Transparency in Clinical Research
Source: Figure 1A. Turner et al. (NEJM, 2008)
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.
Source: Silverstein FE et al. JAMA. 2000 Sep 13;284(10):1247-55.
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 1;324(7349):1287-8.
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- Does not include unpublished results
Policies and Users
International Registries and Number of Trials (as of 2/4/08)
Registry | No. of Trials |
---|---|
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 |
Characteristics of ClinicalTrials.gov
- Web-based registration system (PRS)
- Register through organizational accounts
- Key part of validation
- XML data upload (<20% records)
- Data are dynamic—”data provider” can modify data at any time
- Changes are tracked
Homepage - ClinicalTrials.gov
http://ClinicalTrials.gov/archive
ClinicalTrials.gov General Statistics
ClinicalTrials.gov Statistics (as of February 4, 2008)
Number | Precent | |
---|---|---|
Total Registered Trials | 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
ClinicalTrials.gov Statistics Continued (as of February 4, 2008)
Trials by Data Provider | ||
---|---|---|
Number | Percent | |
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 |
Organizational Accounts
Total | 4,792 |
---|---|
Fed accounts | 71 |
NIH accounts | 26 |
Industry | 1,783 |
Other | 2,912 |
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
Table 4. Attributes of Entries in "Primary Outcome Measure" Field. | ||
---|---|---|
Attribute | Frequency (N=657)* % | Examples from ClinicalTrials.gov |
Vague | 17 | Clinical response |
Tolerability | ||
Domain without specific measure | 19 | Glucose regulation |
Severity of symptoms of schizophrenia | ||
Specific measure without time frame | 23 | Intravenous glucose-tolerance test |
Structured clinical interview -- positive and negative syndrome scale | ||
No. of hospitalizations | ||
Time frame without specific measure | 10 | Tumor response at 3 mo |
Freedom from progression at 2 yr | ||
Improvement in glucose-control over 16-wk period | ||
Specific measure and time frame | 31 | Change in glycosylated hemoglobin from baseline to 6 mo |
Mortality from any cause at 30 days |
*Frequencies are based on a review of 657 records from the top 10 drug companies, ranked according to data from IMS Health on the volume of U.S. sales.23 Phase 2, 3, and 4 Trials were included.
ENHANCE
Source: Kastelein JJ, Sager PT, de Groot E, Veltri E. Am Heart J. 2005 Feb;149(2):234-9.
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Last updated: 23 January 2015
First published: 21 March 2008