DHTs
Evidence generation evolved
The pharmaceutical industry faces a daunting challenge: it takes an average of 12 years and $3 billion to bring a new drug to patients, with the FDA approving an average of 50 new therapies yearly.
This pace is inadequate to address humanity's needs and our own future goal of helping the industry produce ten times the number of treatments it does today.
A significant bottleneck is the lengthy clinical trial process, where Phase 3 studies alone can span three years or more. However, a critical factor compounding these timelines is the difficulty in recruiting sufficient patients for these crucial studies, often adding up to 2 years to the already protracted journey.
Key Insights from the FDA's DHT Guidance
On December 23, 2023, the FDA released guidance for the industry on how digital health technologies (DHTs) should be used in clinical trials.
DHTs, which the FDA defined in their “Framework for the Use of DHTs in Clinical Trials,” are “technologies such as wearable, implantable, ingestible, and environmental sensors and software applications on mobile phones, among others.”
DHTs can be used to collect data from clinical trial participants more efficiently and objectively than traditional methods. For example, DHTs can collect data on participants' activity levels, sleep patterns, and medication adherence. This data can be collected electronically, which can reduce the burden on participants and improve the accuracy of the data
Trends, insights, and news from SCOPE 2024
With over 3,300 attendees across 850 companies, the 16th annual Summit for Clinical Operations Executives (SCOPE) was a huge success. As previous years have shown, what’s big at SCOPE tends to be big for our industry. Thus, we’re summarizing some key takeaways from this year’s conference to understand where the industry may be headed next.