Data and Safety Monitoring
Section 7
Additional Resources
Tools
| Resource | Description |
| Data Monitoring in Pragmatic Clinical Trials: Points to Consider | Resource from the NIH Pragmatic Trials Collaboratory. |
| DMC Charter for Pragmatic Clinical Trials | Template charter outlining procedures and guidance for DMCs of PCTs. |
| Early Stopping in Pragmatic Clinical Trials: Workshop Summary | Synthesizes key themes from an interdisciplinary discussion around decision-making for early stopping of PCTs, including for efficacy, safety, and futility. |
| CTTI’s DMC recommendations | While not specific to pragmatic clinical trials, the recommendations address the role of the DMC, DMC composition, communication among DMC members and other stakeholders, the DMC charter, and issues related to DMC training. |
| Data and Safety Monitoring of NCCIH-Funded Clinical Research | Describes the guidelines for the appropriate oversight and monitoring of clinical research supported by the National Center for Complementary and Integrative Health. |
| NHLBI Policy for Data and Safety Monitoring of Extramural Clinical Studies | Describes the guidelines for the appropriate oversight and monitoring of clinical research supported by the National Heart, Lung, and Blood Institute. |
Presentations
| Resource | Description |
| Data and Safety Monitoring in Pragmatic Clinical Trials (Greg Simon, MD, MPH, and Susan Ellenberg, PhD) | December 8, 2017, NIH Pragmatic Trials Collaboratory Grand Rounds presentation, available as a webinar, slide set, and podcast. |
| Data Monitoring for PCTs (Steven Joffe, MD, MPH; Stephanie Morain, PhD, MPH | April 6, 2022, Slides from a presentation at the IMPACT Collaboratory Annual Meeting. |
| The DSMB Role in Pragmatic Trials: NIMH Progress and Challenges (Galia Siegel, PhD, et al) | July 28, 2017, NIH Pragmatic Trials Collaboratory Grand Rounds presentation (webinar recording and slides). |
| Data and Safety Monitoring Boards for Trials of COVID-19 Vaccines: The Challenges (Susan Ellenberg, PhD) | March 5, 2021, NIH Pragmatic Trials Collaboratory Grand Rounds presentation (webinar recording and slides). |
| Data Monitoring Committees for Pragmatic Clinical Trials (Susan Ellenberg, PhD) | October 16, 2015, NIH Pragmatic Trials Collaboratory Grand Rounds presentation (webinar recording). |
Articles
| Resource | Description |
| Simon GE, Shortreed SM, Rossom RC, Penfold RB, Sperl-Hillen JAM, O'Connor P. Principles and procedures for data and safety monitoring in pragmatic clinical trials. Trials. 2019 | Provides recommendations for key considerations and procedures for appropriate monitoring in pragmatic trials. |
| Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in Clinical Trials: A Practical Perspective. (Second edition). Wiley; 2019 | Provides a practical overview of data monitoring in clinical trials, including the purpose, responsibilities, and operation of data monitoring committees (DMCs). Useful for those managing and conducting clinical trials and those serving on DMCs or regulatory and ethical committees. |
| Irving E, van den Bor R, Welsing P, et al. Series: Pragmatic trials and real world evidence: Paper 7. Safety, quality and monitoring. J Clin Epidemiol. 2017 | Describes practical challenges of collecting and reporting safety data and of monitoring trial conduct while maintaining routine clinical care practice. |
| Ellenberg SS, Culbertson R, Gillen DL, Goodman S, Schrandt S, Zirkle M. Data monitoring committees for pragmatic clinical trials. Clin Trials. 2015. | Describes which PCTs may need an independent DMC and characteristics of PCTs that may have implications for data monitoring. |
| DeMets DL, Furberg CD, Friedman LM. Data Monitoring in Clinical Trials: A Case Studies Approach. Springer; 2006. | A collection of cases are used to explore issues in data monitoring of clinical trials. |
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