Home > BOR > Clinical Trials Working Group > Meeting 1
Activities To-Date, Mockups, and Proposed Data Entry Process
Session 3: Basic Results Database
Deborah A. Zarin, M.D.
Background
Specific Results Data Elements
Data Entry and Display Mockups
Activities to Date
Results Reporting
Results Reporting: Preliminary Activities
- Trans-NIH Working Group on Clinical Trial Results Reporting in 2004
- "Scientific Challenges in the Registration of Clinical Trials" Expert Meeting in November 2006
- Commissioned review of existing results databases
Conclusions from Preliminary Activities
- Two basic models: structured narrative vs. tabular
- Data input should be formatted in a way that facilitates provision of comprehensive and valid data
- Tabular data (vs. narrative) would be easier to curate
Activities since Sept. 2007
- FDAAA mandated "tabular form" for "basic results"
- Specific content of tables identified in law
- Challenge is to determine method for data entry that would facilitate provision of structured data for
- Heterogeneous trial types
- Heterogeneous variable types
Basic Results Tables
- Demographic and baseline characteristics
- Overall and by arm
- Participant flow
- Values for primary and secondary outcomes
- By arm
- Scientifically appropriate tests of statistical significance
Current NLM Thinking
- Developing a model that would allow the registrant to enter information about the trial and the variables, and then enter data into tables
- Professional Services Contracts at NEMC and OHSU
- Evaluate templates using 40 clinical trials, starting with parallel design intervention studies
- Process of iterative revisions
- Process for public comment and review
Results Database Mockups
Proposed Approach
Data in Mock-ups Based on Published Results
Results Record
Background
Published Baseline Data
Results Record
Baseline Demographics
Esomeprazole | Omeprazole | |
---|---|---|
N-1,216 | N=1,209 | |
Age | ||
Mean Age (SD): | 46.5 (12.5) | 46.8 (12.3) |
Number >= 65 Years: | 108 | 121 |
Number < 65 Years: | 1,108 | 1,088 |
Gender | ||
Male: | 494 | 449 |
Female: | 722 | 760 |
Ethnicity | ||
White: | 1,134 | 1,133 |
Other: | 82 | 76 |
Results Record
Baseline Demographics
Results Record
Baseline Clinical Characteristics
Esomeprazole | Omeprazole | |
---|---|---|
N-1,216 | N=1,209 | |
Positive Biopsy for H. pylori | ||
Number with Characteristic | 90 | 96 |
Number without Characteristic | 1,126 | 1,113 |
Los Angeles Classification | ||
Grade A: | 427 | 386 |
Grade B: | 470 | 502 |
Grade C: | 257 | 240 |
Grade D: | 60 | 80 |
Missing | 2 | 1 |
History of GERD |
Results Record
Baseline Clinical Characteristics
Published Participant Flow
Results Record Participant Flow
Published Primary Outcome
Results Record
Primary Outcome
Proposed Data Entry Process
Data Entry Mechanisms
- Electronic Data Interchange – upload data in XML format
- Manual Data Entry – enter data using a Web-based Results Registration System (RRS)
- analogous to the Protocol Registration System (PRS) for the registry
Two-Step Data Entry Process
- Specify "parameters" of results tables
- Baseline Demographic Categories
- Baseline Clinical Characteristics
- Detailed Outcome Measures
- Enter data
Measurement Types
Measurement Types (continued)
Basic Results Data Entry System
- Prepopulates certain data elements from registry, if provided (e.g., Arm Description)
- Lists some prespecified baseline demographics (e.g., gender, ethnicity)
- Allows users to enter and edit tables
- Column labels: e.g., Arms
- Row labels: e.g., demographics, outcome measures
- Cells: e.g., measurement values
Specifying Parameters
Arms & Baseline Demographics
Entering Data
Baseline Demographics
Specifying Parameters
Baseline Clinical Characteristics
Specifying Parameters
Baseline Clinical Characteristics
Specifying Parameters
Baseline Clinical Characteristics
Specifying Parameters
Outcome Measures
Entering Data
Outcome Measures
Data Display Mechanisms
- Summary result records displayed in a Results Database at ClinicalTrials.gov
- Results records linked to registry records via NCT number
- Similar search engine and "look and feel"
- Details to be determined
Results Record Sections
- Background: e.g.,Title, NCT, Sponsor
- Baseline Data (Table 1)
- Baseline Demographics by Arms
- Baseline Clinical Characteristics by Arms
- Participant Flow, including dropout and exclusion
- Outcomes (Table 2), including statistical tests
- Primary Outcomes by Arms
- Secondary Outcomes by Arms
- Administrative: e.g., Point of Contact, Certain Agreements
Results Record
Background
Results Record
Baseline Demographics
Results Record
Baseline Clinical Characteristics
Results Record
Participant Flow
Total | Esomeprazole | Omeprazole | |
---|---|---|---|
Target Enrollment: | 2,080 | 1,040 | 1,040 |
Actual Enrollment: | 2,425 | 1,216 | 1,209 |
Completed: | 2,316 | 1,161 | 1,155 |
Discontinued | 109 | ||
Dropped Out: | 88 | 45 | 43 |
Excluded: | 21 | 10 | 11 |
Results Record
Primary Outcome
How to Facilitate Rational Use of Data
- Provide context
- Study design
- Background information
- Consider linking to systematic reviews
- Link to other resources
Some Other Issues to Ponder
- What constitutes a “minimally acceptable” results record?
- How to handle disputes over validity of information?
- Should post-hoc analyses be allowed on database?
- What external sources should we link to?
Copyright, Privacy, Accessibility, Site Map, Viewers and Players
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services
Freedom of Information Act, NLM Customer Support
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services
Freedom of Information Act, NLM Customer Support
Last reviewed: 30 December 2016
Last updated: 23 January 2015
First published: 24 March 2008
Last updated: 23 January 2015
First published: 24 March 2008