Q&A: Clinical Event Committee, Data Monitoring Committee, Data Safety Monitoring Board, Endpoint Adjudication Committee, Safety Assessment Committee, Steering Committee
Met de verwijzingen op deze pagina wordt getracht te verhelderen wat een Clinical Event Committee, Data Monitoring Committee, Data Safety Monitoring Board, Endpoint Adjudication Committee, Safety Assessment Committee, Steering Committee is, alsmede wat het verschil is tussen deze commissies. Tips of ontbreekt er iets, geef het gerust aan mij door via het contactformulier.
Abbreviations
| CEC | Clinical Event Committee |
| DMC | Data Monitoring Committee |
| DSMB | Data Safety Monitoring Board |
| DSMC | Data and Safety Monitoring Committees |
| DSMP | Data and Safety Monitoring Plan |
| EAC | Endpoint Adjudication Committee |
| iDMC | Independent Data Monitoring Committee |
| SAC | Safety Assessment Committee |
| SC | Steering Committee |
Wat is het verschil?
- Safety Assessment Committee (SAC), Data Monitoring Committee (DMC), Steering Committee (SC), Clinical Event Committee (CEC) (31-03-2022). On Biostatistics and Clinical Trials.
- DMC vs EAC: What’s the Difference? (09-03-2022). Advarra.
- DMC (Data Monitoring Committee) vs. DSMB (Data Safety Monitoring Board) (05-02-2009). On Biostatistics and Clinical Trials.
Guidance, Guidelines
Nederland
Europa
Verenigde Staten
- FDA Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
- National Institute on Drug Abuse (NIDA) – Guidelines for Establishing and Operating a Data and Safety Monitoring Board
- NCI Data and Safety Monitoring Guidelines – Essential Elements of a Data and Safety Monitoring Plan for Clinical Trials Funded by the National Cancer Institute
- NIH/NIDCR – Data and Safety Monitoring Board (DSMB) Guidelines
- NIH Policy for Data and Safety Monitoring (June 10, 1998)
- NIH – Data and Safety Monitoring Boards in NIH Clinical Trials: Meeting Guidance, But Facing Some Issues
- NIH – Further NIH Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials (June 5, 2000)
Advarra
Global
Data Monitoring Committee, Data Safety Monitoring Board, Data and Safety Monitoring Committees
- Schöffski P. Importance and role of independent data monitoring committees (IDMCs) in oncology clinical trials. BMJ Open. 2021 Oct 25;11(10):e047294. doi: 10.1136/bmjopen-2020-047294.
- Drazen, J. M., & Wood, A. J. J. (2010). Don’t Mess with the DSMB. New England Journal of Medicine, 363(5), 477–478.
- When is a DSMB needed? University of North Carolina.
DAMOCLES DSMB Charter
- DAMOCLES studygroup. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. The Lancet , Volume 365 , Issue 9460 , 711 – 722. DOI: http://dx.doi.org/10.1016/S0140-6736(05)17965-3
- Download: DAMOCLES template DSMB-charter
Endpoint Adjudication
- Meah, Mohammed N et al. (2020). Clinical endpoint adjudication. The Lancet, Volume 395, Issue 10240, 1878 – 1882. https://doi.org/10.1016/S0140-6736(20)30635-8
- Held. C. (2018). When do we need clinical endpoint adjudication in clinical trials?. Upsala Journal of Medical Sciences, 124(1), 42–45. https://doi.org/10.1080/03009734.2018.1516706
- Seltzer, J.H., Heise, T., Carson, P., Canos, D., Hiatt, J.C., Vranckx, P., Christen, T., Cutlip, D.E. (2017). Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium. American Heart Journal, 190, 76-85. https://doi.org/10.1016/j.ahj.2017.05.009
- Clinical Endpoint Adjudication Committees: Not Just for “Endpoints” (13-04-2022). Advarra.
- A Look at the Processes Behind Clinical Endpoint and Event Adjudication (06-04-2022). Advarra.
Ethical GmbH
Clinical outcomes, endpoints, primary, secondary, direct or surrogate
Clinical Endpoint Adjudication Charter
Handbook & resources