Morawski, Caroline M
(2024)
Reviewing the State of Data and Safety Monitoring Boards (DSMBs) for Randomized Clinical Trials (RCTs) Before, During, and After the COVID-19 Pandemic.
Master Essay, University of Pittsburgh.
Abstract
Data and Safety Monitoring Boards (DSMBs) in randomized clinical trials (RCTs) in the context of the COVID-19 pandemic are imperative to evaluate as they highlight the benefits to data pooling and DSMB collaboration. Four studies reveal the adaptations DSMBs made during COVID-19. Prior to the COVID-19 pandemic, DSMBs in the United States maintained the standard approach protocol. This protocol encourages RCTs to monitor the data, participant safety, and provide recommendations for the study. These recommendations can include potential termination for the RCT. Findings developed through these reports stress the importance of trial integrity, participant safety, and data monitoring through consistent communication of stakeholders and mutual agreements. These agreements include timeline details and confidentially. Response to the pandemic includes increasing the frequency of analyses and meetings, harmonizing DSMB work, and developing shared data monitoring agreements between RCTs.
Challenges include ensuring data security and confidentiality as well as maintaining urgent progression of the data collection. These reports demonstrate the importance of preparation, transparency, and consistent reporting in overcoming the challenges of urgent public health situations. The recommendations for this evaluation included ongoing collaboration among RCTs and DSMBs during public health emergencies to ensure timely responses to the threat. The public health significance is providing efficient trial monitoring to enhance pandemic preparedness.
Share
| Citation/Export: |
|
| Social Networking: |
|
Details
| Item Type: |
Other Thesis, Dissertation, or Long Paper
(Master Essay)
|
| Status: |
Unpublished |
| Creators/Authors: |
|
| Contributors: |
| Contribution | Contributors Name | Email | Pitt Username | ORCID  |
|---|
| Committee Chair | Wisniewski, Steve | stevewis@pitt.edu | stevewis | UNSPECIFIED | | Committee Member | Mori Brooks, Maria | mbrooks@pitt.edu | mbrooks | UNSPECIFIED | | Committee Member | Neal, Matthew D | nealm2@upmc.edu | UNSPECIFIED | UNSPECIFIED |
|
| Date: |
21 May 2024 |
| Date Type: |
Completion |
| Submission Date: |
24 April 2024 |
| Access Restriction: |
2 year -- Restrict access to University of Pittsburgh for a period of 2 years. |
| Number of Pages: |
22 |
| Institution: |
University of Pittsburgh |
| Schools and Programs: |
School of Public Health > Epidemiology |
| Degree: |
MPH - Master of Public Health |
| Thesis Type: |
Master Essay |
| Refereed: |
Yes |
| Uncontrolled Keywords: |
DSMB Randomized Clinical Trial RCT COVID-19 Data and safety Monitoring Pandemic |
| Date Deposited: |
21 May 2024 13:45 |
| Last Modified: |
21 May 2024 13:45 |
| URI: |
http://d-scholarship.pitt.edu/id/eprint/46271 |
Metrics
Monthly Views for the past 3 years
Plum Analytics
Actions (login required)
 |
View Item |
![[img]](http://d-scholarship.pitt.edu/style/images/fileicons/application_pdf.png)
![[feed]](/images/feed-icon-32x32.png){kind=icon}