Pharma Exec
The Pharma Exec dossier contains resources to support executive decision makers within pharma to champion the appropriate use of digital clinical measures Health outcomes or physiological characteristics of an individual’s health, wellness, and/or condition that are collected digitally with a sensor. in drug development.
Resources include models of the benefits that digital clinical measures can bring to drug development programs today and in the future, the business case for including patient perspective, a summary of recent regulatory positions, and the competitive landscape for digital clinical measures.
This heat map models four categories of benefits cascading from deploying digital clinical measures across the drug development cycle: program and system-level improvements; revenue opportunities; risk reduction; and cost reduction. Download here.
This Micro-Playbook provides details for each of the 20+ benefits listed in the heat map (above) and includes vignettes describing many of these benefits in practice. Download here.
The patient perspective is essential for successful inclusion of digital clinical measures in medical product development. The resource includes two patient centric use cases. Download here.
This document gathers recent and relevant discussion of digital clinical measures from the regulatory perspective. Current state is better than you think! Download here.
This quick reference guide to processes for interacting with the US Food and Drug Administration (FDA) regarding novel endpoint development is adapted from the original developed by CTTI. Download here.
Access DiMe’s library of digital endpoints currently being used in industry sponsored studies of new medical products. Visit library 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).
Have you ever been asked what tangible benefits digital biomarkers bring to clinical studies? Inspired by the book and film Moneyball, the authors developed a novel method to quantify the values of patient selection and endpoint technologies using Monte Carlo simulation. Their work illustrates the model and potential application using Parkinson’s Disease example. This presentation will discuss:
1. The project rationale and Moneyball metaphor
2. SV95C and its clinical study impact
3. Monte Carlo approach and the model
4. The results and the way forward
