1. Pink Sheet
  2. >>Conferences
  3. >>Duke-Margolis Center for Health Policy

Digital Health Technologies: Use In Clinical Studies Comes With Practical Challenges

 
• By Sue Sutter

Whether subjects can use their own personal devices, how to manage mid-study technology updates, and the extent to which data gathered will be shared with patients in real-time are all issues that sponsors, investigators and regulators need to consider.

Smartwatch
Patients generally prefer to wear their own smartwatch if one is needed for clinical trial participation. • Source: Shutterstock

Digital health technologies hold tremendous promise in drug development, including bringing clinical trials to patients and providing a more consistent, and less intrusive, assessment of function and disease impacts.

However, sponsors, investigators and regulators must weigh a host of practical considerations when deciding whether and how to build digital...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Duke-Margolis Center for Health Policy

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

Agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches

 
• By Sue Sutter

The current regulations were written when clinical trials involved far fewer entities, and a certain amount of ‘contortion’ is necessary when sponsors are trying to introduce decentralized, community-based and other modern elements, the FDA’s Kevin Bugin says in an interview with the Pink Sheet.

Preterm Birth Prevention Studies Need To Look Beyond Makena Endpoints, Experts Say

 
• By Sue Sutter

Gestational age and a binary, neonatal composite endpoint are insufficient to assess outcomes that are important to babies and families, clinicians and researchers say, suggesting development of continuous variables or scales with weighted components and a comparison of outcomes among newborns in gestational age ‘buckets.’

More from Pink Sheet

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.