Things & Thinks XV
In this issue of my fortnightly newsletter, I have brought together an update from US FDA and some reflections by Bill Gates, with the usual curated news from the digital health world, a Chart of the Fortnight and a Tweet of the Fortnight.
Diversity in Clinical Trials
US FDA released a detailed guidance on enhancing diversity of clinical trial population. The guidelines talk about the following aspects-
- Broadening eligibility criteria to increase diversity in enrolment
- Study design and conduct considerations to improve enrolment
- Considerations for rare disease trials.
As a proponent of digital health technology, I especially like this particular recommendation about study design/conduct-
Make Trial Participation Less Burdensome for Participants
….consider whether flexibility in visit windows is possible and whether electronic communication (e.g., telephone/mobile telephone, secured electronic mail, social media platforms) or digital health technology tools can be used to replace site visits and provide investigators with adequate real-time data….
Connected devices and sensors will greatly change the way we conduct clinical trials and this will not only bring many advantages to the trial sponsors and regulators but also make the trials more patient-centric.
Digital Healthcare news-Giants, Incumbents and implementers
As I have noted in the past, one of the most viable paths to market for digital health technology is via incumbent pharma/device firms. Case in point-Medtronic launched the InPen device alongside integration with its Guardian Connect connected glucose monitoring (CGM) system. Medtronic acquired the InPen innovator-Companion Medical- in Aug 2020; the device happens to be the only smart insulin pen cleared by the FDA via 510 (k) in 2016 for use by people requiring multiple daily injections.
Carrying on the digital partnership trend, Bayer launched G4A Digital Health Partnership program, through which it will work with a bunch of early & late stage start-ups providing them funds, coaching and possible access to commercial deals.
Google released two new tools that should further the goals for AI in healthcare: the first one-Healthcare Natural Language API-will help in identifying medical insights from unstructured medical notes; the second tool-AutoML Entity Extraction for Healthcare-will provide a low-code interface for broadening access of AI adoption for users with varied technical backgrounds.
Opinions poured in from various experts when Amazon announced its entry into medicine distribution in the US. Jury is still out whether this is truly disruptive or carries through moves by other retail/digital pharmacy incumbents
Omada Health published partial results of one of the largest trials in diabetes prevention using their digital technology-digital Diabetes Prevention Program, d-DPP. However the two arms were not exactly comparable (The d-DPP included weekly video call sessions with a health coach, lifestyle coaching, virtual peer support via interactive group message forums and behaviour tracking tools such as internet-connected scales, activity trackers, blood pressure monitors and blood glucose meters. The patients in the control group, meanwhile, attended a single 90-minute diabetes prevention class.) They also did not report results of one of their secondary endpoints (CV risk).
What happens in 2045?
Bill Gates wrote reminisced about 25 years of The Road Ahead, the book he wrote in 1995. It speaks about vision, uncertainty and of course humility to revisit your visionary thoughts every now and then! The world in 1995 sounds already so different, what will it look like in 2045?
When The Road Ahead came out, people were still navigating with paper maps. They listened to music on CDs. Photos were developed in labs. If you needed a gift idea, you asked a friend (in person or over the phone). Today you can do every one of these things much more easily — and in most cases at a much lower cost too — using digital tools.
Tidbits
- Healthcare Chart of the Fortnight: This chart showing top 12 countries contributing to research output towards UN SDG (Sustainable Development Goals, great to see India’s progress since the launch of SDGs. Hopefully this research output also translates into real-world effects.
- Healthcare Tweet of the Fortnight: Past few days have been busy with results of three COVID-19 vaccines being released in succession, with a lot of analysis of the data that was released (and what was left out). This tweet about the ‘pedigree’ of the Oxford-AZ version was one of the many comments that got passed around…
