Telehealth has been one of the big developments in health care brought on by the COVID-19 pandemic. It both promises to make care easier for patients to fit into their busy lives and holds the potential of allowing trials and new treatments to reach people far from the research hospitals in city centers. However, there are hurdles to overcome before much of this can be a reality. In addition to this topic, we explore the challenges to adopting virtual trials, a Food and Drug Administration examination of gene therapy safety, curing blindness with CRISPR (a genome editing tool), and new findings in data from a major study of Apple Watch wearers.
Each week we highlight five things you need to know in the life sciences industry. Here’s the latest.
1. Telehealth struggles to overcome rural disparities of care
It would be natural to assume that telehealth would be equally accessible to patients regardless of whether they live in urban or rural areas. Stat News points out that this is not necessarily the case and rural communities pose special challenges to telehealth providers. As clinical trials shift to more virtual models that include telehealth, this will be an important challenge to overcome to ensure that virtual and hybrid models provide access to a broader pool of patients.
2. Understanding virtual clinical trials and the transition from traditional models
The adoption of virtual clinical trials requires biopharma companies and clinical research organizations to adopt a range of new technologies. This isn’t a small feat and presents many decisions and a different set of risks compared to a traditional trial. Those challenges notwithstanding, the adoption of virtual trials seems to be maintaining momentum even as the pandemic is starting to recede.
3. Evaluating gene therapy safety is in focus at the FDA
The FDA is examining how it should evaluate the safety of new gene therapies as they move out of the lab and into human trials. These therapies present both great promise and new risks that are not commonly seen with traditional technologies. This presents challenges to biopharma companies as they develop their candidates and design pre-clinical and clinical trials; and for the FDA as they work to ensure safety, efficacy and consistent review standards.
4. CRISPR-based therapies are getting closer to seeing the light of day
A novel approach to using CRISPR to perform gene edits directly in a patient’s eyes has reported mixed results in an early trial of six patients. One third of the patients reported improvements in vision functions and one was able to see well enough to navigate a low light obstacle course. Although these are early results for this potential treatment, it points to the continued promise of developing new therapies based on CRISPR.
5. “Hey, Siri, what is my heart doing?”
Apple received clearance for a feature detecting atrial fibrillation in 2018 based on a study of more than 400,000 people. Within that study, there were also a number of participants who received a notice of an irregular heartbeat which turned out not to be afib. A new study shows Apple Watch detected that many of the study participants were suffering from other types of irregular heart beats.
