The data and safety monitoring board in sponsored pediatric clinical trials: practical applications
Bibliographic record
Abstract
The Data and Safety Monitoring Board (DSMB) monitors the progress of clinical trials for safety and implements stopping rules as needed. Although NIH and FDA guidelines recommend the use of a DSMB for phase I, II, and III pediatric clinical trials, the manner in which the DSMB is constituted has received little attention. In this study we reviewed the Institutional Review Board (IRB) applications submitted between 2008 and 2012 at our institution (Children’s Hospital Los Angeles) for phase I, II and III studies which were multi-site, sponsored and performed under a sponsor’s Investigation New Drug Application (IND) for the type of data and safety monitoring that was being used. Our results indicate that approximately two-third of the studies used an independent DSMB, 10% utilized a sponsor’s DSMB and the remaining studies (25%) did not utilize a DSMB and relied instead on safety monitoring by the Principal Investigator (PI) and the medical monitor/director. This pattern was observed across all study phases and for blinded as well as unblinded studies. Our result suggests that a Data and Safety Monitoring Plan (DSMP), although required by the IRB, is rarely submitted by the sponsor at the time of application. Instead the DSMP is submitted to the IRB by the PI on IRB supplied templates. IRB review of these completed templates were critical to ensuring DSMB related compliance. Additionally, a significant percent of sponsored clinical trials used the PI or an individual designated as medical director/monitor, rather than constituting a DSMB.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.011 | 0.015 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".