Measurement

This map illustrates the different ways that digital clinical measures can be used as digital drug development tools. The checklists that follow will help you ensure you document the recommended level of evidence that is necessary and sufficient to support the use of a digital clinical measure in your context of use. Download here.

If you want to use a digital clinical measure for pre-screening, use this checklist to see if you have enough evidence about your measure. A pre-screening tool will provide some non-binding information to better indicate the eligibility and the assessment of participant-study fit. Download here.

If you want to use a digital clinical measure as a screening tool or to enrich your study population, use this checklist to see if you have enough evidence about your measure.

Generally, this applies to a tool to identify participants who may / may not meet the study inclusion / exclusion criteria or a tool to identify specific participant characteristics where the drug effect is more likely than it would be in an unselected population. Download here.

If you want to use a digital clinical measure as an exploratory endpoint in a non-pivotal trial, use this checklist to see if you have enough evidence about your measure.

Exploratory endpoints may include clinically important events that are expected to occur too infrequently to show a treatment effect or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses. Download here.

If you want to use a digital clinical measure as a secondary endpoint in a non-pivotal trial, use this checklist to see if you have enough evidence about your measure.

Defined here as an endpoint that is pre-specified, included in the statistical analysis plan, and required to be listed on clinicaltrials.gov, but not used to inform power calculation or affect multiplicity adjustment. Download here.

If you want to use a digital clinical measure as an early efficacy endpoint in a non-pivotal trial, use this checklist to see if you have enough evidence about your measure.

Here we mean endpoints that measure efficacy of a drug that may be considered by regulatory authorities. Download here.

If you want to use a digital clinical measure to inform your internal decision making in a non-pivotal trial, use this checklist to see if you have enough evidence about your measure.

This pertains to digital clinical measures that will inform internal go/no-go decisions regarding whether to advance a investigational new drug forward for further testing in a pivotal trial. Download here.

If you want to use a digital clinical measure as an exploratory endpoint in a pivotal trial, use this checklist to see if you have enough evidence about your measure.

Exploratory endpoints may include clinically important events that are expected to occur too infrequently to show a treatment effect or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses. Download here.

If you want to use a digital clinical measure as a non-gated secondary endpoint in a pivotal trial, use this checklist to see if you have enough evidence about your measure.

Defined here as an endpoint that is pre-specified, included in the statistical analysis plan, and required to be listed on clinicaltrials.gov, but not used to inform power calculation or affect multiplicity adjustment. Download here.

If you want to use a digital clinical measure as a key or gated secondary endpoint in a pivotal trial, use this checklist to see if you have enough evidence about your measure.

A secondary endpoint in this case is one you would include in your multiplicity adjustment and submit to regulators to demonstrate additional effects on the disease or condition. Download here.

If you want to use a digital clinical measure as a safety endpoint in a pivotal trial, use this checklist to see if you have enough evidence about your measure.

Safety endpoints are assessments that reflect safety of a new drug, biologic, or device. Download here.

If you want to use a digital clinical measure as a primary endpoint in a pivotal trial, use this checklist to see if you have enough evidence about your measure.

Primary endpoints most accurately measure the benefit of the therapy/drug/intervention being studied (efficacy); this is the most clinically important endpoint. Download here.

If you want to use a digital clinical measure for safety surveillance in the post-market, use this checklist to see if you have enough evidence about your measure.

Here it includes digital clinical measures that track the occurrence of adverse events in the post-market to monitor the safety of medical products. Download here.

If you want to use a digital clinical measure as a digital companion product in the post-market, use this considerations document to help you decide whether you have enough evidence about your measure.

Here they are digital clinical measures integrated with either a drug or biologic to support dosing and other feedback loops.

Note: 1) integration of the digital tool with an existing drug or biologic requires a label change for the drug or biologic and 2) regulatory requirements may recognize digital tools coupled with a drug or biologic as a combination product. Download here.

If you want to use a digital clinical measure for screening in post-market studies, use this checklist to see if you have enough evidence about your measure.

Here it is a tool to identify participants who may / may not meet the study inclusion / exclusion criteria in a post-market setting. Download here.

ICYMI Listen to the panel of experts from this Tour of Duty who collaborated to create the resources in this Dossier as they share their perspectives on the challenges and the opportunities to advance the use of digital clinical measures (excerpted from our launch event on April 30, 2021).