Medidata suggests mobile health data considerations for clinical research

Engaging Patients

Medidata suggests mobile health data considerations for clinical research

“Consumers have their choice of hundreds of thousands of mobile health (mHealth) apps”…that “are engaging patients in new ways and in real time, thus becoming an integral part of the healthcare infrastructure,” according to an article sponsored by Medidata, global provider of cloud-based technology and data analytics for clinical research, in an article in the June 5 issue of Fierce Biotech.

Medidata recently presented information about the use of its mobile health apps technology in clinical trials at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. Working with experts from The University of Texas MD Anderson Cancer Center, Weill Cornell Medical College and Roche, Medidata discussed data and regulatory aspects of mobile apps role in clinical development, the mobile app regulatory environment and tailoring apps to assure appropriate data collections.

According to Medidata, mobile apps are only as useful as their collectible data. Thus, clinical trial sponsors and researchers must understand what is needed in their apps in order to make them successful. Mobile apps can be a vital connection between researchers and patients. To use them in clinical development, researchers need to make sure that the data collected is relevant to continued research and drug approval applications. Thus, sponsors need to play a role in app development to assure the success of mobile health apps in clinical trials, explained Medidata, which works with global pharmaceutical companies, biotech, diagnostic and device firms, academic medical centers and contract research organizations. 

During the pre-trial phase, Medidata encourages companies working with a partner to develop a clinical trial app to understand what needs to be measured and to work closely with the app development partner early in the process to get the most out of varying data complexity and quality. To obtain the best data quality, the article suggests the use of “active tasks and built-in sensors on the patient’s smartphone” that can be captured with minimal additional technical effort. By using these measurements and using methodological rigor in the pre-trial phase, clinical researchers can “establish a baseline and quality control metrics for the app and allow monitors to identify sources of potential error,” the article said.

To maintain efficiency and trending throughout the trial, researchers need to monitor the data and user compliance consistently. They need to be able to look at trends over time and see how data end points correlate with them.

After the clinical trial, the raw data gathered from an active task app need to be transformed to data visualizations and actionable insights for clinical development programs.  The article recommends “keeping adequate documentation for regulatory authorities to describe algorithms, quality control methodology and raw data transformations.”

The key, according to Medidata is to “engage patients by using a robust selection of mobile health solutions…Use sensors and apps to capture a richer, more complete dataset directly from the patient.  Gain unprecedented visibility into the patient journey, and provide researchers a more objective, nuanced picture of a therapy’s safety and efficacy.”

“Consumers have their choice of hundreds of thousands of mobile health (mHealth) apps”…that “are engaging patients in new ways and in real time, thus becoming an integral part of the healthcare infrastructure,” according to an article sponsored by Medidata, global provider of cloud-based technology and data analytics for clinical research, in an article in the June 5 issue of Fierce Biotech.

Medidata recently presented information about the use of its mobile health apps technology in clinical trials at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. Working with experts from The University of Texas MD Anderson Cancer Center, Weill Cornell Medical College and Roche, Medidata discussed data and regulatory aspects of mobile apps role in clinical development, the mobile app regulatory environment and tailoring apps to assure appropriate data collections.

According to Medidata, mobile apps are only as useful as their collectible data. Thus, clinical trial sponsors and researchers must understand what is needed in their apps in order to make them successful. Mobile apps can be a vital connection between researchers and patients. To use them in clinical development, researchers need to make sure that the data collected is relevant to continued research and drug approval applications. Thus, sponsors need to play a role in app development to assure the success of mobile health apps in clinical trials, explained Medidata, which works with global pharmaceutical companies, biotech, diagnostic and device firms, academic medical centers and contract research organizations. 

During the pre-trial phase, Medidata encourages companies working with a partner to develop a clinical trial app to understand what needs to be measured and to work closely with the app development partner early in the process to get the most out of varying data complexity and quality. To obtain the best data quality, the article suggests the use of “active tasks and built-in sensors on the patient’s smartphone” that can be captured with minimal additional technical effort. By using these measurements and using methodological rigor in the pre-trial phase, clinical researchers can “establish a baseline and quality control metrics for the app and allow monitors to identify sources of potential error,” the article said.

To maintain efficiency and trending throughout the trial, researchers need to monitor the data and user compliance consistently. They need to be able to look at trends over time and see how data end points correlate with them.

After the clinical trial, the raw data gathered from an active task app need to be transformed to data visualizations and actionable insights for clinical development programs.  The article recommends “keeping adequate documentation for regulatory authorities to describe algorithms, quality control methodology and raw data transformations.”

The key, according to Medidata is to “engage patients by using a robust selection of mobile health solutions…Use sensors and apps to capture a richer, more complete dataset directly from the patient.  Gain unprecedented visibility into the patient journey, and provide researchers a more objective, nuanced picture of a therapy’s safety and efficacy.”