Next Steps in Digital Evolution
Exploring how the clinical trial enterprise can benefit from new advances and emerging opportunities in digital health technology.
While we continue to speed through the first half of 2024, it was not long ago that the very end of 2023 saw the FDA release a final guidance on the use of digital health technologies (DHTs) in clinical trials. Titled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations”, the document outlines how DHTs can be leveraged to streamline operations and most importantly, improve the patient experience. This final guidance followed great efforts by the FDA in establishing a stakeholder program to bring even more awareness to the use of DHTs. Having only been released for about four months, the new guidance has prompted fresh approaches in utilizing DHTs in drug development. This April issue of Applied Clinical Trials focuses on just that—and ways the industry can advance and better harness these new digital opportunities.
This month’s quartet of feature articles begins with a comprehensive overview of the DHT space, exploring considerations such as choosing the right vendors, ensuring fit-for-purpose training, and key steps related to informed consent. Our next piece focuses on one of the most widely used forms of DHT, wearables. Outside of the technical and operational aspects of these devices, there are several other important factors to weigh with wearables, such as regulatory compliance and ensuring patient privacy, as the piece delves into. The next feature for April examines DHTs in the context of data collection. With so much volume of patient data—in varied formats—available and accessible these days, including clinical outcome assessments (COAs), the ability to align each as part of the "precision measurement ecosystem" is key to transforming the patient experience. This piece also presents a use case in neurology. Rounding out our features is a look at personal health records in putting "the power back into the hands of patients” and helping to usher in the digital-era shift in research—and, thus, patient care and therapeutic innovation.
In addition to our regular columns in this issue, we are pleased to introduce a new “In-Focus” article element within the news section, tied to each issue's main topic. Christine Bahls, a freelance writer for medical, clinical trials, and pharma information, will offer unique angles or drilled-down analysis and overviews of notable activity related to theme, including key insights from industry leaders. For this month, she explores how Big Pharma is stepping up its efforts to keep pace with emerging digital technologies, with some companies incorporating them from "discovery to therapy."
As always, thank you for reading.
Mike Hennessy Jr is president and CEO of MJH Life Sciences®
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
