December 8, 2023
December is here; the end of 2023 fast approaches. For those operating in the life sciences sector, it’s all too clear that the time has come for 2024 industry predictions.
In a first instalment, we hear from Curavit Clinical Research. Last year, co-founder and chief medical officer Dr Pam Diamond predicted that 2023 would herald the FDA becoming more directive and collaborative on guidelines for decentralised clinical trials (DCTs), that more clinical trials services would become remote (beyond just patient monitoring), that AI innovation would expand its application to enhance patient experience, and that digital therapeutics (DTx) companies would focus on the difficult last mile to commercialisation…
This year, Joel Morse, Curavit’s CEO and founder, and Rachel Rangel, clinical trial specialist, share their predictions for the future focus of digital therapeutics and Health Economics Outcomes Research (HEOR), as well as tunnelling down into the ins and outs of effective DE&I in clinical trials.
DTx: The case for going straight to consumers
Joel Morse thinks that digital therapeutics companies will continue to pivot away from prescription models.
In 2023, Pear Therapeutics filed for bankruptcy and Akili abandoned the prescription business model. Both DTx companies raised hundreds of millions of dollars by going public in SPAC transactions. While each company successfully gained FDA approvals, says Morse, the current market acceptance for prescription digital therapeutics is low and improvements will take years.
Given this, he believes many DTx companies will pivot away from the prescription model and go straight to consumers next year, while continuing to run clinical trials to confirm their claims and value proposition, but not seeking FDA approvals.
Leveraging data for pre-screening and health economic analysis
As pertains to HEOR, Morse thinks it will become more common in DCTs.
This year saw the maturation of Claims and Health Information Exchanges, which enable a cost-effective and straightforward process for researchers to gain access to identified patients’ data. Given the improvements in costs, Morse says, trial sponsors can now take advantage of these exchanges at scale and leverage the data for both pre-screening and health economic analysis.
As DCTs and virtual site acceptance accelerates, a knock-on effect will be that more of these trials will include HEOR analysis, Morse predicts.
Diversity, equity, and representation in clinical trials
Rachel Rangel, meanwhile, notes that last year the industry re-committed to improving diversity, equity, and representation in clinical trials. Thanks to new regulatory legislation issued by the FDA that requires sponsors of certain clinical trials to submit diversity action plans, report demographic data for participants, and actively recruit from underrepresented populations, top pharmaceutical companies are now prioritising DE&I across their trial portfolios.
For instance, in March 2023, Bristol Myers Squibb announced a multimillion dollar investment in its global inclusion and diversity goals, including a focus on increasing clinical trial diversity. The company claims that nearly 60% of its clinical trial sites are now located in racially and ethnically diverse areas of the country.
While the industry is moving in the right direction, though, racial and ethnic minorities still only account for 2% to 16% of clinical trial participants, while they comprise 39% of the US population.
One of the biggest obstacles is patient recruitment and retention from historically underrepresented populations, says Rangel. That’s why sponsors like MedRhythms are starting to collaborate with partners that specialise in diverse patient recruitment to carefully plan and execute new strategies that reduce some of the traditional barriers to study participation and are more conducive to reaching a broader demographic.
Actionable solutions that will flourish in 2024, predicts Rangel, include:
- modern research models, such as decentralised clinical trials that use virtual sites to meet participants where they are;
- partnerships with community organisations, leaders and medical providers;
- diverse research teams who can better understand participants from these communities;
- real-time monitoring to expeditiously rectify any gaps in representation early; &
- a focus on cultural linguistic barriers, by translating study materials into different languages, using culturally appropriate messaging, and providing interpretation services as needed.
Looking forwards
Be sure to keep an eye out for further 2024 predictions instalments. In the meantime, if you missed the pharmaphorum Frontiers Health 2023 wrap-up podcast, be sure to tune in below for insights on: how digital health and digital therapeutics are shifting the paradigm of care sites; some lessons and discussions from the DTx Global Policy Summit; the current investment landscape; and a broad discussion on AI
You can listen to episode 106 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it – and subscribe to the rest of the series – in iTunes, Spotify, acast, Stitcher, and Podbean.
About the contributors
Joel Morse is founder and CEO of Curavit. He is an experienced operational CEO who has founded, built, and sold large global businesses in healthcare and life sciences. Previously, he founded C3i, a Business Process Outsourcing (BPO) healthcare provider. Morse has a BSc in Mechanical Engineering from Tufts, and an MBA from Columbia.
An audiologist by trade, Rachel Rangel has over 10 years of experience as a medical provider. She has served patients across the US — from rural towns to major cities, in small private practices, children’s rehabilitation hospitals, and large medical systems. As the head of Curavit’s Diversity, Equity, & Inclusion initiative, Rangel is working to make clinical trials a more welcoming and inclusive space to those from traditionally underserved and marginalised communities.
