News Roundup: December
With the proliferation of wearable technology, read time data is accessible like never before. Telehealth appointments, remote monitoring services, and a growing network of technology-savvy healthcare providers make decentralized clinical trials a popular choice for both researchers and participants.
The devices themselves are smaller, less expensive, and lack social stigmas that have plagued wearables in the past. Participants are more likely to engage with a trial and stay aligned on data collection, strengthening the findings of a study as a whole.
Check out the what we’ve been reading lately about wearables and DCT advancements below.
Wearables
New York Times, October 15th, 2023
Researchers at Oxford University have developed a new way to track the progression of Parkinson’s disease (PD) using wearable sensors. In this study, seventy-four participants with PD visited the lab seven times at 3-month intervals, and their walking and postural sway were recorded using six wearable sensors.
ML algorithms were used to estimate the MDS-UPDRS-III score, a clinical rating scale for PD motor symptoms. Clinical rating scales are used to assess PD motor symptoms, but they are subjective and can be influenced by inter-rater disagreement.
Results of the study indicate that the sensors can “track the motor symptom progression in people with PD better than the conventionally used clinical rating scales.” Because PD affects over 100 million people worldwide, researchers hope that this new method will help them to develop better treatments and new prognostic tools for patients with PD.
Pharmaphorum, October 30th, 2023
AI and ML advancements are expanding the use cases of wearables industry-wide, and pharma companies are demonstrating to the medical community how and why wearables work in this new field of real-time data collection. Medical grade biosensors, outfitted with either static or dynamic AI, now have the capacity to improve clinical trial efficiency, reduce costs, and save lives. Regulations and best practices have traditionally trailed behind the technology breakthroughs in wearables, so it’s important to
It’s now common for smart watches and other fitness trackers to be able to send real-time electrocardiogram data straight to medical professionals.
DCTs
Applied Clinical Trials, October 13th, 2023
Clinical trials are absolutely necessary, but cost the medical industry greatly in both time and money. Decentralized clinical trials (DCTs) and digital health technologies (DHTs) can help reduce costs and increase efficiency. VP of Clinical Affairs at MEDIcept, Inc, Adelina Paunescu examines how the industry can begin to prepare for the potential cost reductions now by planning effectively.
With new protocols coming out of the FDA, clinical trial strategy planning should be first on the list. DCT design should be adaptive and use a simplified protocol whenever possible. There’s no need to collect unimportant data. Paunescu urges trial designers to partner with site groups across wide geographical areas and diverse populations, working with inclusive communities already in existence. Patient-facing technologies should be utilized for pre-screening and recruitment, thereby reducing travel costs and time-consuming in-person visits. She believes that taking advantage of technological advancements like eConsent, wearables, home health monitoring, and quick, verifiable data exchange systems will enhance patient engagement and reduce the need for repeated trials.
Paunescu concedes that the cost of technologies employed in the trial and the need to ensure data security and privacy might be obstacles, but that with careful oversight, sponsors can partner with technology and digital health companies to address these challenges and achieve future cost savings.
Med City News, October 2nd, 2023
It’s no secret that people of color, LGBTQ+ patients, and those in medically underserved urban and rural communities are often prevented from accessing, trusting in, and receiving optimal clinical care. This is due in part to bias in clinical research, which can lead to drugs with better tolerability and efficacy for communities where patients are “better insured and generally healthier.” In fact, most trials are conducted among patients who are largely white, affluent, and male. AI can be used to dismantle bias in clinical research by making it easier for all patients to participate in trials, ensuring that more people have access to safer and more effective drugs.
AI programs like Stanford’s Trial Pathfinder can help with identifying investigators and patients in communities not typically represented in research, and helping to ensure the quality and equity of datasets, platform features, and processes used to drive computer-assisted decision making.
