mHealth

The role of the cloud in realizing the practical benefits of mHealth in clinical trials.

In this interview, Dr. David Lee Scher adds his perspective on how digital health is changing in both healthcare and clinical trial settings.

The Duke Margolis Center for Health Policy (DMCHP) recently collaborated with the FDA to release an mHealth action plan entitled "Mobilizing mHealth Innovation for Real-World Evidence Generation."

Austin Speier, VP of Emerging Technologies at Precision for Medicine, recently spoke about mHealth regulatory pathways at PanAgora’s Mobile Innovations Summit, and will elaborate further in this Q&A interview.

Jeff Lee had the opportunity to be a moderator at the Mobile in Clinical Trials event where he sat down with mobile experts within the pharmaceutical industry. The session allowed for new observations in regards to the value that these mobile technologies have within clinical trials.

As the clinical trials industry starts to incorporate mHealth initiatives into their trials, study teams now have to determine the extent of their ICF consent forms during study deployment, and how to cover mHealth activities within these forms.

This Q&A discusses how the movement in making studies more patient-centric continues, and Pfizer is now implementing its own mHealth study in Lupus.

The adoption of electronic health records by hospitals and providers has increased engagement in Health Information Technology (HealthIT) activities. Nora Belcher of the Texas eHealth Alliance speaks on how HealthIT will change the pharma landscape for drug development.

John Reites, formerly of Quintiles, and current Chief Product Officer at THREAD Research, discusses how mHealth is incorporated in clinical trial patient centricity.

While many would like to see mHealth and wearable technologies incorporated in clinical trials, regulatory guidance has yet to be established for these innovations. However, some guidances do exist on the regulation and validation of mHealth use in consumer settings.

Technology now provides many advances that can determine the future of clinical trials. How sponsors, vendors, regulators and new entrants to the sector manage this transition will determine how effectively the industry adopts these tools.

mHealth is making a strong case for its ability to optimize clinical trials and improve engagement with participants and patients.

Electronic data collection has grown rapidly over the course of the last ten years.

Cenduit has benefited greatly from the relationship we have with our parent companies, from Quintiles’ clinical development experience to Thermo Fisher Scientific’s clinical supply chain know-how.

Optimizing study protocols and improving data quality have been notable areas of focus in the biopharmaceutical industry; the total number of endpoints in a typical Phase III protocol increased from 7 to 13.

The introduction of easily worn biosensors, such as FitBit, Garmin’s Vivofit, and Apple’s iWatch, have created a large influx of interest in the area of mobile health (mHealth).

Nowhere has the advance of technology left its footprint more visibly than in the field of healthcare and clinical research.

 ResearchKit is Apple’s foray into clinical research based on the backbone of its HealthKit, released  in June 2014, which offered the ability for health and fitness apps to communicate with each other. mHealth News reported Apple CEO Tim Cook said, “As we worked on HealthKit, we came across an even broader impact that iPhone could make, and that is on medical research.”

The potential for mHealth to positively impact clinical trials is extraordinary, but as we’re in the early days, there are far more questions than answers.

Practical issues that accompany the decision to integrate PDAs and other handheld devices.

Practical guidance for effectively integrating PDAs and other handheld devices into CTs