I returned from the exciting JP Morgan 41st Annual Healthcare Conference last week in San Francisco and greatly enjoyed learning from the speakers and leaders in the pharmaceutical industry on the latest trends and thinking. I put together this short blog that highlights my key takeaways from the conference which I hope will be helpful to clinical trial leaders and investors who weren’t able to attend – at the end of this post, I also share how the work we’re doing at Strados aligns extremely well with these takeaways.
The popularity of DCTs continues to increase, driving significant value
Tufts CSDD recently presented a peer-reviewed paper demonstrating the cost-effectiveness of decentralized trials. This research, coupled with similar adoption by enterprises like GSK led to meaningful discussions around how much time and money can be saved through such initiatives – up to 13 times return on investment for late-stage clinical trial studies, or 5 times in early stages!
A continued focus on the patient experience and building trust
The trend towards making clinical trials more patient-centered continues. New models emerge for better engaging patients (e.g. CVS entering the retail market) and many pharmaceutical companies are considering participant needs at key moments such as during protocol design and in choosing which technologies to implement.
More guidance and regulations to support decentralized clinical trials (DCTs)
Pharmaceutical organizations can expect to see the regulatory landscape shift to reflect a more decentralized approach. This comes after the US Funding Bill for Clinical Trial Diversity and Modernization was passed along with an EMA Recommendation Whitepaper supporting DCT elements in Clinical Trials. The FDA has welcomed such changes as it promotes trial diversity and better patient-reported outcome data from Oncology studies.
A renewed push to get better patient data for clinical trials
There is an overall focus on better and more patient data collection for clinical trials. This can be seen in a shift towards clinical trials moving to retail (e.g. CVS and Walgreens entering the market) in an effort to use data pharmacy records to collect real-world evidence, as well as the FDA now requiring additional “confirmatory trials” for accelerated approvals.
After leaving the conference and taking in these learnings, I couldn’t help but notice how the Strados RESP™ biosensor fits seamlessly with what’s happening in the industry. Specifically:
— Our device offers respiratory researchers an FDA-cleared way to monitor patients at home, aligning with the growing trend towards DCTs. As alternative technologies for cough monitoring are not fully DCT compatible, we are excited about the possibilities for the RESP Biosensor.
— As researchers continue to understand the value of patient-centricity and trust in clinical trials, they will look to devices like ours that offer less burden and greater privacy (eg. lightweight, can be worn whether the participant is at home or going to work, encrypted step-to-step).
— What I’m especially excited about: clinical researchers’ need for enhanced patient data aligns with our device’s novel method for capturing patient respiratory symptoms. The RESP Biosensor’s ability to capture symptoms such as wheezing, rhonchi, and rales alongside cough, as well as continuous monitoring to understand change over time truly offers researchers a more complete picture of their patients’ respiratory health.
Thank you for reading and if you have any questions or thoughts please feel free to submit a comment below or send us a message here.