1 / 20

CTEP, NCI Adverse Event Reporting Programmatic & Workflow Processes

CTEP, NCI Adverse Event Reporting Programmatic & Workflow Processes. Prepared by: Ann Setser May 24, 2010. Agenda. Conceptual overview of NCI AE reporting CTEP Adverse Event Reporting Systems Multiple mechanisms for AE data submission Routine via CTMS; CDUS; CDS Expedited via AdEERS

cathal
Télécharger la présentation

CTEP, NCI Adverse Event Reporting Programmatic & Workflow Processes

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. CTEP, NCI Adverse Event ReportingProgrammatic & Workflow Processes Prepared by: Ann Setser May 24, 2010

  2. Agenda • Conceptual overview of NCI AE reporting • CTEP Adverse Event Reporting Systems • Multiple mechanisms for AE data submission • Routine via CTMS; CDUS; CDS • Expedited via AdEERS • AE Reporting Workflow • Variable practices • Issues to consider for integration of PRO-CTCAE

  3. NCI AE Reporting Overview • Methodology varies widely among sites, modalities, specialties, practices • There are no guidelines or uniform methods for how to capture, present and interpret AE data  • Within NCI, requirements differ • Paper CRF • Multiple data systems (Groups, Centers, CTEP, contractors, others) • At the patient encounter, most clinician- documented AE / symptom data are not CTCAE terms and often include notes that do not promote straightforward translation to CTCAE Grade (severity indicator)

  4. NCI AE Reporting Overview… • From patient encounter to sponsor analysis and publication, many layers of ‘interpretation and translation’ of AE terms and severity indicators occur. • CTCAE data is a collection of secondary endpoints used to generate an overall picture or general safety profile of a given treatment, to identify gross trends and differences between studies, arms, groups, etc.

  5. CTEP Adverse Event Reporting Systems • Clinical Data Update SystemCDUS • Primary resource of clinical trial data for NCI DCTD and DCP • Types of Data Sets • Abbreviated CDUS (Phase 3 - no AE data) • Complete CDUS (Phase 1, 2 AE data) • Methods of Data Submission • ftp data transfer • web • Contents of data set • Cumulative data per protocol

  6. CTEP Adverse Event Reporting Systems… CDUS Data Submission • Early Phase 1 • via CTMS (Clinical Trials Monitoring System) • File Transfer Protocol (FTP) • Monthly • Other Phase trials: • via CDUS • Lead Group or Lead Institution submits data set • FTP or web • Quarterly

  7. Adverse Events Screen

  8. Steps

  9. CTEP Adverse Event Reporting Systems…AdEERS Adverse Event Expedited Reporting System • Expedited AE reporting tool for CTEP sponsored trials • Expedited reporting (AdEERS) is always in addition to Routine Reporting • All AEs (meeting the CDUS reporting requirements) must be submitted as part of routine reporting • AdEERS does not replace Routine Reporting

  10. CTEP Expedited AE ReportingAdEERS • CTEP-specific rules as a sponsor reporting to FDA • The foundation of AdEERS is CTCAE • Unlike industry (verbatim coded to MedDRA) • AdEERS ‘rules’ based on CTCAE depend on Phase of Trial

  11. Example: CTEP AdEERS ‘Rules’

  12. CTEP Expedited AE ReportingAdEERS • Because of timeline requirements, AdEERS data is usually closer to patient encounter • Requires extensive patient level data entry each time a report is generated • Data reviewed by CTEP almost real-time • 24 hours • 5 days • 10 days • Next slide: Screensnap of AdEERS with Sections of Report

  13. Screensnap of AdEERS with Sections of Report

  14. CDUS-reported and AdEERS-reported AEs • Design and expectations of two systems are very different • CDUS = summary cumulative AE data by quarter • AdEERS = detailed AE data in real-time 2. Initially there was no expectation for comparison of data from the two systems • Programmatic data element requirements differ • Different staff with different AE expertise submit to the different systems 3. AdEERS-CDUS Reconciliation implemented April 1, 2006 • Comparison of the data reported to the 2 systems • All Grade 5 discrepancies must be resolved • All other discrepancies result in a CDUS caution

  15. Workflow Processes for reporting Routine AEs - Paper At the patient encounter clinician documents AEs / symptoms On paper Patient chart / Progress Note Trial-specific ‘cheat sheet’ / AE CRF Electronic Electronic Health Record Remote Data Capture System Nurse, CRA, or Data Manager retrospectively reviews source data Translates symptoms into CTCAE terms and grades and transcribes onto trial-specific AE CRF

  16. Workflow Processes for reporting Routine AEs - Paper… • Site personnel submit paper CRF to Cooperative Group or Lead Organization • Cooperative Group or Lead Organization personnel enter AE data into data system • Technical staff prepare and submit electronic data to CTEP via CDUS ftp

  17. Workflow Processes for reporting Routine AEs - Electronic… • Site access to RDC, CDMS, etc. • Site technical staff program local data file transfer to Group data system • Group technical staff prepare CTEP- required subset of all Group data and reprograms for submission to CTEP CDUS

  18. Going Forward with PRO-CTCAE • Understand strengths and limitations of current AE data systems and processes—from patient encounter to sponsor to regulators to publication • With awareness of the varied processes (paper, electronic), how best might PROs be integrated and help achieve more real-time AE reporting? • How will PRO data be analyzed / utilized relative to clinician-reported AE data? • How can we achieve a common method to summarize and communicate overall AE burden?

  19. Acronyms

  20. Discussion

More Related