NETHERLANDS – Royal Philips has unveiled a new at-home ECG system for use in decentralized clinical trials.
This new technology is being marketed by the company as a way for clinical trial participants to record ECG data without having to travel to a clinical site or hire an in-home clinician.
Participants in the trial wear a PCA 500 ECG body patch with a 12-lead ECG that can securely transmit data in “near real time” via Philips’ cloud-based data collection and analysis service.
The system is now available in select markets in North America, Europe, and Asia, according to the European medical device company.
According to Philips, the shift toward more home-based monitoring tools could reduce clinical trial attrition rates.
Historically, attrition rates in clinical trials have been a source of concern. A study published in Cancer, for example, discovered that the median attrition rate for supportive and palliative oncology clinical trials was 28% for the primary endpoint and 44% for the end of study.
“Our customers are seeking solutions that will help them to address key challenges that can stand in the way of extracting meaningful insights from their clinical trials,” Andy Broadway, general manager of ambulatory monitoring and diagnostics at Philips, said in a statement.
Decentralized clinical trials are becoming more popular in the life sciences and research communities.
Indeed, 50 life science and healthcare organizations, including AstraZeneca, the FDA, and Pfizer, have joined forces to form the Decentralized Trials and Research Alliance (DTRA), which is dedicated to the adoption of patient-focused decentralized clinical trials and research.
A number of digital health startups are developing tools to allow for decentralized trials. Swift Medical, a digital wound-care company, launched a new digital imaging platform in September to support decentralized clinical trials.
The technology was created to aid in large-scale image collection and management, allowing researchers to track the impact of medical interventions at different locations or at home.
Hundreds of millions of dollars are being poured into the space by investors. In October, for example, digital clinical trial platform Medable received US$304 million in Series D funding.
Trial Spark’s US$156 million Series C round, Florence’s US$80 million Series C round, and Lightship’s US$40 million funding round are among the other large funding rounds in the space.
Science 37, a veteran decentralized clinical trial company, went public in May 2021 after a more than US$1 billion SPAC merger with LifeSci Acquisition II Corp.
Blank-check firms, or SPACs, are publicly traded shell companies that raise funds to merge with a private company, bringing it public and allowing it to avoid the scrutiny of a traditional IPO.
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