Digital medicine initiative to focus on sensor data integration
The new initiative, says the organization, will develop resources to improve the effective and efficient use of digital health products in clinical research and patient care, enabling researchers and clinicians to use increasingly ubiquitous sensor data to make better decisions, faster.
“In order to expand the use of digital sensor products and fulfill the promise of digital health measurement to redefine healthcare,” says Ieuan Clay, Chief Scientific Officer at DiMe, “stakeholders including clinicians, researchers, patients, regulators, and payers must be able to leverage sensor data that is trustworthy, relevant, and accessible. We have identified this as the biggest limitation to scaling digital health measurement and have gathered a best-in-class project team with regulators, cloud and analytics platforms, healthcare systems, pharmaceutical, and standards organizations to help us design the solutions.”
Accelerated by the COVID-19 crisis, the use of digital health measurement has been growing rapidly across clinical research and patient care. Recent initiatives by DiMe, such as The Playbook which serves as the foundation for digital measurement and remote monitoring, have supported the safe, effective, and equitable implementation of digital health into practice.
However, says the organization, despite its Library of Digital Endpoints observing a 665% spike in the number of unique digital endpoints being used in industry sponsored trials of new medical products over the past two years, there has not been a new medical product approved using sensor data. Additionally, while there have been reports of a ‘monumental shift towards remote patient monitoring’ in the press, only 11% of telehealth visits during the pandemic used remote patient monitoring, according to physician surveys.
Digital clinical measures and remote patient monitoring, says the organization, cannot become an integral part of clinical research and clinical care if the technical and business processes that combine sensor data with other relevant information cannot render at scale a unified, single view of the data that is sufficiently trustworthy, relevant, and accessible for high quality decision making.
“If we want to keep our current momentum,” says Jennifer Goldsack, Chief Executive Officer at DiMe, “our industry will require a set of guidelines that address the considerations involved with integrating these data into platforms that manage study data or help clinicians guide patient care. DiMe is thrilled to lead this new initiative to develop a deep understanding of these gaps and begin to address them.”
Participating organizations include:
- Amazon Web Services (AWS)
- Center for Drug Evaluation and Research, US Food and Drug Administration
- Center for Devices and Radiological Health, US Food and Drug Administration
- Evidation
- HumanFirst
- IEEE Standards Association
- Medable
- Moffitt Cancer Center
- Oracle
- Open mHealth
- Savvy Coop
- Takeda
- Veterans Health Administration
For more, see the DiMe’s Playbook guide for developing and deploying digital clinical measures across clinical research, clinical care, and public health.
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