Contemporary Trends, IT Systems and
Technologies in Clinical Trials
Dr. Sandeep Bagga, PhD
Scientific Advisor
Interactive Voice Response (IVR)
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Multiple native languages
Operate continuously
Global access
Cost effective
IVR System
• Streamlines and expands the patient enrollment
process
• Automates and implements even the most complex
randomization to ensure both participant and data
integrity
• Tracks and monitors drug inventory helping to
manage drug costs, production, and supply
• Collects recorded and electronic patient reported
outcomes.
Case Report Form
• Case Report Form (CRF) is the name given to the
collection of forms used to record data obtained
during a clinical study
- Completed by the investigator or study
staff
- Based on data from source documents
- Reviewed by the monitor
- Entered into the computer
- Must be completed as designed, so NO
CHANGES to the CRF may be made by the
study site
Case Report Forms for FDA office
Why Electronic Record Keeping
- Increases Speed of Information Exchange
- Reduces Errors
- Data Integration
- Improves Process Control
- Economical Data Management
- Easy Accessibility
Case Report Form (Web Browser Interface)
• Standard Pages
- Simplifies CRF completion
- Identical or similar formats for multiple
studies
- Demographics
- Inclusion/Exclusion Criteria
- Physical Exam
- Medical History
- Laboratory Analysis
- Adverse Events
- Concomitant Medications
Case Report Form (Web Browser Interface)
• Study Specific Pages
- Designed specifically for an individual
study
- May be a ‘standard’ type of page, but
designed specifically for a particular study
- Efficacy Evaluations
- Drug Accountability
Document Imaging
• A true paperless environment
• Transform documents into instantly
accessible files
• Save on physical storage space
• Reduce retrieval time and lost files
ICR/OCR/OMR technology
• ICR – Intelligent Character Recognition
Reads human hand printed text
• OCR – Optical Character Recognition
Reads computer generated text
• OMR – Optical Mark Recognition
Reads mark sense fields
such as check boxes
Regulatory Requirements for Clinical Trials Record
• IND regulations 21 CFR 312
- 312.62(b) Prepare and maintain adequate and
accurate case histories
- 312.68 Permit FDA to have access to, and
copy and verify any records or reports
required under 312.62(b)
- 21 CFR 11 applies if the above are electronic
Challenges in Defining Standards
- Uneven levels of technology
- Different regulatory practices/procedures
- Reaching internal (co.) consensus on configuration
- Development and transition costs
• Rewriting regulations, SOPs & retraining personnel
- Communicate to policy makers
- Crucial to maintain flexibility and openness to change
- Avoid jargon (easy to understand by all)
- Cutting edge technology is often not a motivation for change
Data Review
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CRFs are coded
Data entered into computer system
Diagnostics are developed
Data review conventions are developed
Internal data review
Computer-assisted review
Corrections made to data
Corrected data sent for analysis
SAS Reporting Tools
SAS is a registered trademark of SAS Inst., Inc., in
United States of America and other countries
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Reading external data
Processing SAS data sets
Storing SAS data sets
Sorting SAS data sets
Documentation and coding
SAS XPORT
• Processed by:
- XPORT engine in V6 & beyond
• Why XPORT?
- Ease of use in Pharmaceutical/Biotech industry
- Well tested by US FDA and industry
- Data transfer to/from common DB systems
- ASCII based
- It is computer platform independent
To/From XPORT Processing
• Extension Identifies File Type
Data Sets
Corresponding
Transport Files
SAS System Viewer
Efficacy and Safety Results (Examples)
Incidence of Adverse Events by Treatment Groups
Displayed by Body System
Assessment
A
(N=33)
B
(N=34)
C
(N=33)
Body as a whole
Headache
Chills
2 (6%)
0 (0%)
1 (3%)
2 (6%)
4 (12%)
0 (0%)
Digestive Sys
Vomiting
Nausea
Stomach Ulcer
4 (12%)
2 (6%)
2 (6%)
2 (6%)
3 (9%)
0 (0%)
2 (6%)
1 (3%)
0 (0%)
Conclusion
Computer Assisted NDA
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Electronic data capture
Data readily available on screen
Electronic linking of documents
SAS datasets with programs
Submission
Seeking Vacation !
Not Approvable Letter (314.120)
• The FDA believes the NDA is insufficient to justify approval
• The letter describes the deficiencies
• Within 10 days, the Sponsor must do one of the following:
- Amend, or notify the FDA of an intent to amend, the NDA
- Withdraw the application
- Ask for a hearing
- Ask for an extension so the sponsor can consider options
- If a Sponsor fails to respond within 10 days, the FDA
will automatically withdraw the application
US FDA Action Letters
Approvable Letter (314.110)
• The application substantially meets the requirements for
marketing approval
• The agency thinks it can approve the application if specific
additional information or material is submitted or specific
condition are agreed to by the applicant
• Most often the FDA requests changes in proposed labeling
and safety update reports
Approval Letter (314.105)
• Drug is approved as of the date of the letter
• The Sponsor is required to submit final printed
labeling
Finally, thank you for attending!
My email address is:
sbagga@visionpointsystems .com
URL:
www.visionpointsystems.com
Address:
10201 Lee Highway, Suite 224
Fairfax, VA 22030