Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials
Bibliographic record
Abstract
Background: The proliferation and increasing maturity of biometric monitoring technologies allow clinical investigators to measure the health status of trial participants in a more holistic manner, especially outside of traditional clinical settings. This includes capturing meaningful aspects of health in daily living and a more granular and objective manner compared to traditional tools in clinical settings. Summary: Within multidisciplinary teams, statisticians and data scientists are increasingly involved in clinical trials that incorporate digital clinical measures. They are called upon to provide input into trial planning, generation of evidence on the clinical validity of novel clinical measures, and evaluation of the adequacy of existing evidence. Analysis objectives related to demonstrating clinical validity of novel clinical measures differ from typical objectives related to demonstrating safety and efficacy of therapeutic interventions using established measures which statisticians are most familiar with. Key Messages: This paper discusses key considerations for generating evidence for clinical validity through the lens of the type and intended use of a clinical measure. This paper also briefly discusses the regulatory pathways through which clinical validity evidence may be reviewed and highlights challenges that investigators may encounter while dealing with data from biometric monitoring technologies.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.664 | 0.797 |
| Meta-epidemiology (narrow) | 0.003 | 0.003 |
| Meta-epidemiology (broad) | 0.011 | 0.009 |
| Bibliometrics | 0.009 | 0.012 |
| Science and technology studies | 0.003 | 0.017 |
| Scholarly communication | 0.021 | 0.020 |
| Open science | 0.010 | 0.005 |
| Research integrity | 0.017 | 0.018 |
| Insufficient payload (model declined to judge) | 0.005 | 0.003 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".