Results Reporting in ClinicalTrials.gov
Office for Clinical Research (OCR) team led by Nagzah Ali and Carmine Santoianni is responsible for reporting results in ClinicalTrials.gov. Learn about the background, history, requirements, and consequences of noncompliance in clinical trials registration.
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Office for Clinical Research (OCR) Results Reporting in ClinicalTrials.gov Nagzah Ali Carmine Santoianni
Team List and Acknowledgments Team: Nagzah Ali Carmine Santoianni Acknowledgments: Jennifer Prozonic Andrena Lawrence Executive Sponsor: Robin Ginn Office of Quality Support Liaison: Terry Anderson
Background What is ClinicalTrials.gov?
Continued Background 1997: Food and Drug Administration Modernization Act (FDAMA) established ClinicalTrials.gov 2000: ClinicalTrials.gov launched 2005: International Committee of Medical Journal Editors (ICMJE) requires registration of trials (including at ClinicalTrials.gov) 2007: Food and Drug Administration Amendments Act (FDAAA) expands ClinicalTrials.gov to require registration of more studies and results and adds penalties for noncompliance 2008: ClinicalTrials.gov adds basic results modules, including adverse events 2014: Medicare claims require NCT number (ClinicalTrials.gov identifier) Source: http://clinicaltrials.gov/ct2/about-site/history
Continued Background Why do I have to register a study in ClinicalTrials.gov?
Continued Background 1. It s the law - FDA Amendments Act of 2007 (FDAAA). 2. Publishing - International Committee of Medical Journal Editors (ICMJE) To learn more about FDAAA 801 Requirements and ICMJE requirements, visit: http://clinicaltrials.gov/ct2/manage-recs/fdaaa and http://www.icmje.org/journals.html
Continued Background Who is responsible for registering the trial? The Sponsor (known as the Responsible Party ) Types of Sponsors Industry sponsor (e.g., Pfizer) Sponsor-investigator (e.g., Emory-owned, investigator- initiated trials) PI at the academic institution or other organization that initiated the study
Continued Background Consequences of Noncompliance ICMJE PI cannot publish in journals following ICMJE policy, and other select journals FDAAA Public notices of noncompliance and violations Withholding of NIH funds FDA sanctions Civil monetary penalties (up to $10,000/day) To learn more about FDAAA 801 Penalties, visit: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf
ClinicalTrials.gov Problems A study record can have multiple problems. Auto-generated by the system based on previously entered information (e.g., completion date, study start date, etc.) ClinicalTrials.gov Quality Assurance review comments by NIH staff can also generate problems for discrepancies/inconsistencies in the study record that require clarification
Types of Problems 9% 20% Late Results - per FDAAA Missing FDAAA Information Never Released 3% Not Completed Not Recently Updated - Not Recruiting 34% Not Recently Updated Ready for Review and Approval 18% Update Not Released Pending PRS Review Comments 4% 11% 1%
Aim Statement Prevent 95 % of study records in ClinicalTrials.gov from FDAAA late results registration beginning October 1st, 2014 through August 1st, 2015.
Process Mapping for Results Reporting Old Process New Process
Study Record Status in ClinicalTrials.gov* *As of September 1, 2014
ClinicalTrials.gov Records with Anticipated Results Entry 35 30 Number of Studies with Late Results 25 Test of Change Records with "Late Results" Due 20 Projected Resolution of "Late Results" Problems 15 - - - - 95% Reliability Line 10 5 0
Test of Change #1 TEST OF CHANGE LESSON(S) LEARNED Email to PI asking for working manuscripts/publications for results reporting prior to study showing up as a late result problem PIs/study teams are busy/unresponsive Publication/manuscript contains information that is not compiled in the same manner required by ClinicalTrials.gov system for reporting
Test of Change #2 TEST OF CHANGE LESSON(S) LEARNED Email PI forms created based on their individual study protocol (in tabular form) PIs more engaged when emailed a form Make form(s) clearer
PI Response Times from Test of Change #1 and #2 Response Time (Days) 30 Pending statistical analysis 25 Pending statistical analysis 20 Days Test of Change #2 15 Test of Change #1 10 5 0 A B C D E F G PI
Ongoing Process Improvement Projects with ClinicalTrials.gov in OCR 700 600 OCR & 500 ClinicalTrials.gov Record Alignment Project End Initial OCR Clean-Up Project 400 # Problems Begin 2nd Phase of OCR Clean-Up Project 300 # of Studies with Problems Quality Academy project 200 # Studies in CT.gov (Total Records) 100 0
Barriers Possible Barriers Plan to overcome Study status can change (i.e., terminated) which can effect projected resolution Reach out to PIs quarterly to check status of study Study transferred to Emory from other institutions, which is unpredictable Communicate with new PI PI leaves institution and new PI assumes role of maintaining the study record Communicate with new PI
Barriers Barriers Encountered Overcame Study registered incorrectly (two different cohorts = two study records) Registered study for PI correctly and future goal to register all Emory- sponsored trials PI is unavailable Made sure to follow-up upon their return ClinicalTrials.gov website revamp Learned the new system prior to contacting the PIs Outcome measures were not available in the one year deadline as required by FDAAA (currently undergoing statistical analysis) Results template given to statistician to fill out as statistical analysis is occurring
Next Steps Continue tests of change into August 2015 Develop new processes and standard operating procedures (SOPs) for proactively addressing all problems Ensure accurate registration of clinical trials into ClinicalTrials.gov Continue to adapt to changing rules and policies for ClinicalTrials.gov and ongoing website changes
