Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials

The rise of technology in clinical research allows us to capture meaningful aspects of health in clinical study participants. In addition to questionnaires collected electronically, biometric monitoring technologies such as wearables, are now used by sponsors for drug approval—and require rigorous statistical analysis to generate acceptable clinical evidence.

We are now facing a question: What are the scientific, statistical, and regulatory frameworks for demonstrating the clinical validity of novel digital measures?

To explore this question, Adriano Fontanari, Product Marketing at Alira Health, joined Bohdana Ratitch PhD, and her team as a contributor for the article “Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials.”

The paper “Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials” is part of work by the Digital Medicine Society (DiMe) research team, “Standardized statistical approaches to analyze and interpret BioMeTs data,” led by Yasaman Damestani, PhD.

Publications
Published on:
September 16, 2022
Written by:
Adriano Fontanari
About Alira Health

As experienced consultants, we can help you navigate the complex demands of clinical research. We can provide your company with strategic advice and solutions designed to ensure success across the full product lifecycle.

Related news

Publications September 16, 2022
Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials
The rise of technology in clinical research allows us to capture meaningful aspects of health in clinical study participants.
Biometrics Clinical eCOA
Publications September 7, 2022
The Promise and Reality of Decentralized and Hybrid Clinical Trials in Europe Today
To understand the challenges related to hybrid and decentralized trials and ways to overcome them, we spoke with Dr. Hervé Solatges, Product Management, Evidence, and Innovation (DCT(...)
Clinical Decentralized Clinical Trials Hybrid Clinical Trials
Publications September 5, 2022
Taking In-Licensed Biologics to Market: Challenges, Complexities, and Ways to Overcome Them
Taking a biologic through drug development to market is highly complex and filled with challenges. To understand these challenges, their implications and how to overcome them, we spoke(...)
Biologics Clinical Drug Development
Events August 10, 2022
DPHARM
We are pleased to announce that we will be sponsoring and attending DPHARM, a unique event focused on the latest innovations that modernize clinical trials.
Clinical Decentralized Clinical Trials DPHARM Patient Centric
Publications August 2, 2022
GMP Manufacturing and IND-Enabling Studies of a Recombinant Hyperimmune Globulin Targeting SARS-CoV-2
The last two years have brought forward tremendous advances in the development of prophylactic and therapeutic approaches for the treatment of SARS-CoV-2 infections.
Clinical CMC Vaccines
Events May 27, 2022
PSI 2022 Conference
We are pleased to announce that this year we will be joining PSI 2022 Conference, the principal annual event for statisticians in the pharmaceutical industry, as sponsors, exhibitors, and delegates.
Biometrics
Multimedia May 19, 2022
Fireside Chat Replay: Latest Developments in Oncology Supportive Care
In this fireside chat, we sit down with two medical experts in oncology and discuss some of the fascinating developments that are happening in the oncology supportive care field.
Clinical
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.