How Do iComply? A Look at Regulatory Topics Surrounding the Use of mHealth Technology in Clinical Trials
The U.S. National Institutes of Health (NIH) Consensus Group has defined mHealth as “the use of mobile and wireless devices to improve health outcomes, health care services and health research.” The mHealth landscape is expanding with over 97,000 apps (mobile applications) as of 2013. Yet the vast majority of these apps have not been through the FDA medical device review process. Full stop? Not necessarily. A quick search on Clinicaltrials.gov reveals 131 interventional trials are in someway relying on mHealth technology (over 1,000 trials when searching on “mobile health”). Add in the splash of the Apple ResearchKit announcements and mHealth beckons further consideration by the research community. (more…)
Life science companies are continuously looking for ways to advance clinical research while simultaneously improving the understanding of drugs they are developing. One of the biggest issues for researchers is the high failure rate of new drugs during clinical development. The stakes are high in a global pharma market that is expected to exceed $1.2 trillion by 2018.
We recently caught up with James Moon, a biostatistician at the Fred Hutchinson Cancer Research Center. Moon works on the Lung-MAP clinical trial, or the Lung Cancer Master Protocol, which uses an innovative trial design meant to improve drug development.
Lung-MAP seeks to match the biomarkers of individual patients’ lung cancer tumors with specific medicines in hopes that a more tailored approach will create more benefit. The trial is an example of the emerging field of “precision medicine” that takes the individual patient’s unique genetic makeup into account.
The Lung-MAP “master protocol” refers to the single protocol (trial) to test four drugs at once rather than the traditional method of testing four drugs in four trials. There is growing interest in such trial designs, also known as “platform trials,” as a way of accelerating drug development.
The Lung-MAP clinical trial uses Medidata’s Rave for electronic data capture (EDC).
What do you think the next step will be in the ongoing evolution of clinical trial design?
Have you ever wondered what others in the life sciences think the future holds for mHealth enabled clinical trials? Medidata asked just this question at a panel moderated by our own Kara Dennis, Managing Director of mHealth, at the NY Bio 25th Anniversary Conference this spring. In the video clip above you’ll get an overview of the panel from a couple of the speakers who joined us at the event.
In the clip you’ll see Kara Dennis, Tomasz Sablinski, CEO of Transparency Life Sciences, and Valeska Schroeder, vice president of product management at Vital Connect, discussing their companies and products as well as their thoughts on the future of mHealth in clinical trials. One of our speakers even believes that designing clinical trials around mHealth technology could reduce research costs by 90% or more!
Aside from the panel, one of the other event highlights was keynote speaker Siddhartha Mukherjee, the Pulitzer Prize winner for “The Emperor of All Maladies.” The cancer physician and researcher will also be our keynote speaker at the Medidata Symposium in Washington, DC, this October.
Interested in learning more about introducing mHealth into clinical trials? Be sure to check out our website for more information on how our products can speed up innovation in drug development and enhance patient engagement.
As we highlighted earlier this week, Ken Skodacek, policy analyst for the clinical trial program in the Office of Device Evaluation, CDRH, says the FDA “wants to stay out of the way of rapidly evolving technologies that ultimately promote public health.”
FDA has a message for sponsors that want to incorporate mHealth technology into their clinical trials: as long as the technology can be clinically meaningful, don’t let us get in your way. (more…)
We had a chance to catch up with Julian Jenkins, the head of GlaxoSmithKline’s digital platform performance unit, to talk about the opportunities and risks for mHealth tools in clinical trials, and it was great to hear more about GSK’s interest in this space.
We chatted with Julian on the sidelines of the DIA Annual Meeting, and he shared his thoughts on how mHealth tools can generate value for companies and how to overcome perceived barriers to adoption.
Our own Phil Coran, Medidata’s senior director of quality and regulatory affairs, chaired a DIA panel with Julian, Pfizer’s Craig Lipset, and Philip Kronstein from the Office of Scientific Investigations at FDA’s Center for Drug Evaluation and Research. FDA’s message was clear: The agency wants to be partners in innovation with pharma and is very open to conversations about incorporating mHealth into clinical trials. We look forward to moving the conversation forward.
Craig Lipset leads Pfizer’s clinical innovation department for worldwide R&D, and in his role he helps shape new practices for clinical development at Pfizer, which includes exploring the use of wearable devices and sensors in clinical trials. Wearable devices receive plenty of attention in the consumer setting, and they are now receiving increased consideration in the clinical setting as well. (more…)
Dave Gemzik, Medidata’s Principal for Strategic Consulting Services, will speak at the DIA Annual Meeting in Washington, DC about creating high quality clinical trial protocols through a data-driven approach. He is speaking at a session focused on improving the effectiveness of medical writing, and Dave’s presentation will help illustrate the value of arming medical writers with a structured protocol design and data and how doing so can optimize study designs to impact clinical development. We provide here a snapshot of some of the points he will address at DIA.
The term “personalized medicine” is frequently added to the discussions of how to improve health care, and a new breed of medical devices called companion diagnostics are much of the backbone for this new approach to personalized care. (more…)
The fact that a digital strategy is reaching into the depths of the largest pharma companies is extremely encouraging for the continued evolution of clinical development, says Donald Jones, the chief digital officer at Scripps Translational Science Institute, which serves as the world’s first clinical trials center focused exclusively on digital medicine.
- The Value Proposition for mHealth in Clinical Trials
- Five Considerations For Wearable Devices In Clinical Trials
- What Does FDA’s Mobile Medical App Pyramid Mean For Companies?
- FDA Wants Your mHealth Clinical Trials
- Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
This article originally appeare ...How Wearables and Mobile Health Tec ...
This article originally appear ...The Future of Clinical Trial Design ...
https://www.youtube.com/watch?v=9M2 ...What’s Ahead for mHealth Enabled ...
Have you ever wondered what oth ...What Does FDA’s Mobile Medical Ap ...
[caption id="attachment_1 ...
Taking ePRO to New Places – Replacing Paper
“Painful Memories” – How Memory Biases Affect Patient-reported Outcome Measures
In a way the patients memories are accurate if you think of them remembering "average pain" rather than "peak pain"...
Taking ePRO to New Places – Replacing Paper
Clear and concise description of Patient Cloud cost benefits vs. Paper. Used it today!
What Advocates Said to Congress During Rare Disease Week on the Hill
Great post Steve. I am mother to Hunter, a RARE terminal ill three year old with SMA Type 1. I'm...
Are Your Data Cleaning Cycle Times Out of Control?
Steve, I'm confused about this graph. You say that time from visit to query close is in the 30 day...
Clinical Data Analytics
Clinical Study Design
Clinical Trial Budgeting
Clinical Trial Management
Clinical Trial Phases
Cloud Computing, SaaS and PaaS
ePRO and mHealth
FDA and Regulatory Affairs
Innovation and Entrepreneurship
Interoperability and eClinical
Randomization and Clinical Trial Supply
Security and Confidentiality
Site Engagement and Monitoring
Technology and Agile Development