mHealth

As wearable ECG technology advances, cardiac safety studies in clinical trials are evolving to capture richer, continuous heart data while reducing patient burden.

In this Q&A, Megan Bailey, EVP and president of central laboratories and international, Labcorp, discusses how central labs are evolving beyond testing to become strategic partners in clinical trial success.

Exploring the different stages in the development of a digital measure, and the activities and steps key to achieving meaningful impact for patients.

Clinical trial liaisons rather serve as experts in their therapeutic areas and as clinical trial specialists to provide a suite of strategic advantages to benefit a study.

Key considerations in deploying fit-for-purpose digital health technologies in drug development.

Evolving mindsets are opening the door for industry to utilize new mediums for understanding patients.

Research has suggested that cough may be associated with worse outcomes in pulmonary fibrosis. Boehringer Ingelheim will assess how monitoring cough and crackles with the RESP Biosensor can be used to monitor the status of patients with this disease.

Digitalization has been progressively facilitating increased access to trials by helping alleviate logistical burdens, but not much is known about how these tools can address the needs of patients with multiple chronic conditions.

Moving beyond the pill to extend the value being delivered to patients.

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.