Snapshot of the Story

The Oxford University coronavirus vaccine being developed with AstraZeneca is being tested in Brazil and South Africa, as well as in the UK. Why? Because you need people with the disease to test it on. Having said that, according to a paper in Nature, of the 2,000 Covid-19 clinical trials registered around the world, more than 90 per cent are in ''wealthy'' countries, with China and India accounting for the bulk of the rest. Less affluent countries in Africa, Asia and Latin America barely get a look in. 

Why Is This Notable? 

1. There have always been ethical questions about running trials in poorer or less developed countries because of the possible lack of people's awareness of rights, lack of regulatory rigor, and other social/ economic inequalities. So, suggesting that we ramp up testing of drugs in these nations can seem a bit controversial. 
2. One of the things I have been concerned about during Covid-19 is that even if we do manage to develop a vaccine in record time, when will this actually reach masses in Africa and LATAM? There has been a history of medicines that are tested in rich countries taking years to reach poorer ones.
3. Contrary to popular belief, many Asian and African countries have excellent clinical trial infrastructure and have built up expertise over the years to combat many epidemics, such as SARS and Ebola.  

Industry Implications

1. What have we really tested, and will it work on the populations that need it most? 
2. Testing in the right places for the right indications should be the best practice: let us not for example test malaria medication in Iceland. 
3. On whom will the tested benefit first :Medication approval should always benefit the populations on whom they were trialled. Only seems fair, right? 

Snapshot of the story

Pear Therapeutics announced recruitment for a remote, 9-week insomnia treatment trial to collect real world data for a digital therapeutic (DREAM) back in February of this year. The study enrolled its first participant this week. This is an open-access, open-label, decentralized clinical trial to collect real-world evidence for PEAR-003A, a digital therapeutic delivering CBT-I. 

Why is this notable?

1. Recruitment is virtual. 
2. The hallowed Real World Data (RWD): Engagement, adherence, healthcare utilization, medication utilization, health economic impact, and clinical outcomes in sleep, depression and anxiety in people with chronic insomnia will be evaluated in a real-world environment.
3. Timely alternative to dependency-inducing insomnia meds: In April, the FDA issued a new warning for several insomnia medications. Having a rigorously validated DTx as an alternative is a welcome move at this time.  

Industry Implications

1. Quick trials for DTx: This study of 350 participants is due to finish by the end of January 2021. That's under 1 year from the kick off date. Pending meaningful results, this may imply that trials in digital health can be significantly faster when it comes to validating initial assumptions (or expectations?).
2. Trial continuity during COVID: This is a great example of how we can continue to run trials during COVID by utilizing telehealth and remote monitoring as an alternative to in-person clinic visits. I cannot guesstimate costs, but it's safe to say it'll be cheaper! 

Snapshot of the story 

CVS Pharmacy launched a new app, SpeakRx, which can read prescription labels out loud for the visually impaired. This essentially provides an audible label that reads important information including patient name, medication name, dosage and directions aloud in either English or Spanish. This new tool will help ensure that visually impaired patients are taking the correct prescriptions and as prescribed.  

Why It is Notable

Technology and Ophthalmology are striking up a friendship. Even though it is a late entrant to the digital health space, digital ophthalmology solutions are slowly but surely demonstrating potential to support patients with eye conditions  - whether it is novel POC diagnostics, or remote, mobile based visual acuity tests.  

Designing for marginalized groups: Whether it is social, economic or pathological, there seem to be certain groups that we fail to recognize to design our products and services for, and this is a step in the right direction to ensure people with visual impairment adhere to their meds.  

Industry Implications

Integration first: SpeakRx integrates with Siri or Google Assistant to read out prescription instructions.  

Slow adoption: The SpeakRx app is being rolled out in CVS outlets across the country, but it will be just the end of 2021 when the roll out phase is expected to be complete. Seems like a long time to make an app available across the country, isn't it, especially in the context of wide dissemination of mhealth during COVID?