For clinical trials
Interim Trial Decision Support
Sensitive digital measures to assess treatment signals, reassess power, and guide sample-size re-estimation.
BioSensics works with sponsors and their clinical and statistical teams to analyze repeated digital measurements during ongoing trials. We assess emerging treatment signals, revisit assumptions for the planned endpoint and analysis, and evaluate power and sample-size scenarios. Findings support decisions to continue as planned, implement a prespecified adaptation, or stop for futility.
Assess the signal. Reassess the trial.
Use planned interim reviews to assess emerging treatment signals and revisit the assumptions behind trial power. Sensitive digital measures provide information on change and variability to support decisions about trial continuation, sample size, and follow-up.
Interim decisions start with sensitive measures
Bring measures of gait and balance, activity, upper limb function, cognition, speech and voice, and video-based biomarkers into a planned interim review. Evaluate change and variability in the intended population to inform treatment-signal assessment and trial planning.
The approach can support trials with a planned interim review, including Phase 2 and rare-disease studies.
What your team receives
Analyses and recommendations that connect sensitive digital measures with the decisions facing your trial team.
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Measure selection and data readiness
A rationale for the selected digital measures and review timing, supported by an assessment of sensitivity to change, reliability, data quality, assessment completion, and monitoring coverage.
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Interim treatment-signal analysis
Analysis of change from baseline and, where authorized, differences between treatment groups. Interpret the size, consistency, and uncertainty of observed changes alongside other clinical outcomes and safety findings.
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Power and sample-size reassessment
Power reassessment and sample-size re-estimation using agreed treatment-effect assumptions and interim estimates of variability. Compare enrollment and follow-up scenarios for the specified endpoint and planned analysis.
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Decision scenarios and recommendations
A comparison of continuing as planned, adapting the trial, or stopping for futility against prespecified criteria. Document the evidence, assumptions, uncertainty, and practical implications of each option.
Configured around your trial
Align the digital measures, endpoint, review timing, and adaptation options with your trial's objectives and statistical analysis plan.
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Endpoint and measure alignment
Define how each digital measure will contribute to the trial, whether as an endpoint or supporting information. Base power calculations on the endpoint being evaluated; justify any use of other measures to inform its assumptions.
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Review timing and statistical assumptions
Plan collection and interim review around expected response timing and participant burden. Specify the effect sizes, variability, longitudinal correlations, missing-data assumptions, and follow-up scenarios to evaluate.
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Prespecified adaptation rules
Define review criteria, sample-size limits, and adaptation methods in advance. Use statistical methods that account for planned interim reviews and changes while preserving the reliability of the final analysis.
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Blinding and authorized review
Specify independent analysis and review roles, including a data monitoring committee or independent statistical group where required by the design. Limit comparative interim findings to authorized reviewers and define the information available to sponsor personnel managing trial conduct.
From digital measures to trial decisions
Plan the interim review, collect informative measurements, and evaluate the evidence for continuing or adapting the trial.
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Agree on the decision plan
Select measures supported by sensitivity evidence. Define the endpoint, analysis, review milestones, adaptation rules, and data-access responsibilities with the sponsor's team.
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Collect and review the data
Review repeated measurements, assessment completion, monitoring coverage, and follow-up. Check data quality and missing-data patterns before interpreting changes.
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Reassess signal, power, and sample size
Evaluate emerging changes and authorized treatment-group comparisons. Update relevant assumptions and compare power and sample-size scenarios using the agreed statistical framework.
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Inform the next trial decision
Bring the analyses together with clinical outcomes and safety. Document the evidence for continuing as planned, implementing a planned adaptation, or stopping for futility.
Planning your interim decision-support approach
Key questions about sensitive measures, power, sample size, timing, and review responsibilities.
Which digital measures can be included?
Select measures of gait and balance, activity, upper limb function, cognition, speech and voice, or video-based biomarkers. Fall monitoring, physiological measures, and participant reports can provide additional context. Evaluate reliability, clinical relevance, and sensitivity to change in the intended population and review period. Natural-history evidence can inform selection and variability assumptions; treatment responsiveness requires its own supporting evidence.
How are power and sample size reassessed?
Update relevant assumptions using interim data and prespecified statistical methods. Depending on the design, this may use blinded variability estimates or authorized treatment-group comparisons. Power reassessment and sample-size re-estimation remain tied to the specified endpoint and analysis. If a digital measure differs from the primary endpoint, its role in informing primary-endpoint assumptions must be justified.
When should the interim review take place?
Set milestones around the expected treatment response, accumulated follow-up, and amount of usable data. Define permitted changes to enrollment or follow-up, adaptation limits, and decision criteria in advance. The review evaluates whether continuing or adapting the trial supports target power to detect a clinically meaningful treatment effect, if present.
Who receives comparative interim findings?
Comparative interim findings, including unblinded results, are restricted to the independent statistical group and authorized reviewers specified in the analysis and data-access plan. These may include a data monitoring committee or adaptation committee, depending on the design. Sponsor personnel managing trial conduct receive only permitted summaries and recommendations that preserve blinding and trial integrity.
How does this connect with other BioSensics services?
Endpoint Development and Validation builds the measurement strategy and supporting evidence. Clinical Trial Operations supports assessment deployment and data delivery. Data Analysis and Scientific Reporting provides documented analyses and interpretation, while Regulatory Support organizes evidence for discussions about the intended use of digital measures. These services can be coordinated around the trial's interim review plan.
Connect your research with the right support
Coordinate measurement development, operations, analysis, and regulatory evidence around your trial's objectives.
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Digital Endpoint Strategy
Select and specify sensitive digital measures before the trial, including the assessment schedule and data needed for a planned interim review.
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Endpoint Development and Validation
Develop candidate measures and supporting evidence for the intended clinical trial use.
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Clinical Trial Operations
Configure and deploy digital assessments, support sites and participants, and deliver study data according to the operating plan.
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Data Analysis and Scientific Reporting
Turn trial data into documented analyses, interpretable findings, and scientific reports.
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Regulatory Support
Organize the scientific and technical evidence supporting discussions about digital measures and their intended use.
Plan your next interim review
Share your indication, endpoint, trial design, and planned review milestones. We can help select the digital measures and define the interim analyses, power reassessment, and sample-size scenarios that will inform your decisions.