25 Jun 2015

Five Considerations For Wearable Devices In Clinical Trials

by Geeks Talk Clinical

mHealth Wearables and the Internet of ThingsCraig 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…)

10 Jun 2015

The Data-driven Protocol Design

by Geeks Talk Clinical

Dia 2015 #MOVEfwd

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.


04 Jun 2015

Finding The Right Drug For The Right Person At The Right Time With Companion Diagnostics

by Barbara Elashoff

iStock_000003715444LargeThe 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…)

28 May 2015

The Promise Of The Digital Health Revolution For Clinical Trials

by Geeks Talk Clinical


WatchThe global head of research at Sanofi put a policy in place to attach a digital health strategy concept to each molecule that goes through the pharmaceutical company’s pipeline.

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.


22 May 2015

Eli Lilly And Company Has A Plan To Speed Clinical Development In Emerging Markets

by Geeks Talk Clinical

Eli Lilly

Chito Zulueta was appointed president of emerging markets at Eli Lilly & Co. in 2014. He has held various roles at Lilly, most recently as president of Eli Lilly Japan. He spoke with us about the company’s clinical development strategy for emerging markets like China and South Korea.


06 May 2015

Eisai Chief Medical Officer Stewart Geary On Clinical Trial Complexity

by Geeks Talk Clinical

Stewart Geary smile

Clinical trial costs are increasing, and there’s no clear sign that these increased costs are improving the clinical trials process.


08 Apr 2015

The Internet of Things (IoT) and Clinical Trials — A Natural Pairing Without the Need to Pair

by Ross Rothmeier

What? Sending data to the cloud without needing a tablet, laptop, smartphone?

It’s Bluetooth, but in a way that you may not recognize; 4.2 changes everything!
Low power, and not “paired” with your smart device.

It’s not glamorous.

There is no UI.
You won’t even know it’s there, but it enables a data collection instrument to push data directly into the cloud.

This opens up amazing options for direct data capture, which means more accurate data, more quickly, and at a lower cost.

Fundamentally, this could be the basis of mHealth, introducing things like:


















and more! For example: 6 Wearables That Will Enhance The Wearable Revolution In 2015

Here is a basic overview of Bluetooth 4.2, which is at the heart of the transformation: Bluetooth 4.2, The Foundation For IoT Devices

But how you ask?
It’s fairly simple, really:














There are some challenges to this method of collecting data. There is some variability in the accuracy of the devices, and the sensors consume precious battery power, so must be recharged.

Because of this, the validity of the data for use in a clinical trial could be questioned, unless it is coupled with data collected and managed in the proper context and with the proper controls.

According to research done at the University of Wisconsin published in January 2015, fitness trackers vary quite a bit due to hardware updates and calibration of them to an individual biology.

Clinical data relevance depends on more than knowing the number of steps taken. A person’s fitness is a combination of many factors, and tracking fitness also involves more than data collection.

In a paper published in August 2014 in the Journal of Internet Medical Research (JMIR), “Behavior Change Techniques Implemented in Electronic Lifestyle Activity Monitors: A Systematic Content Analysis,” it was found that behavior change to improve fitness was actually driven more by the app than the device:

Electronic activity monitors contain a wide range of behavior change techniques typically used in clinical behavioral interventions. Thus, the monitors may represent a medium by which these interventions could be translated for widespread use. This technology has broad applications for use in clinical, public health, and rehabilitation settings.

In another publication at the University of Texas, The UTMB Newsroom | UTMB Health, it was concluded that the software around the tracker is where the true health benefit lies. By extension, I believe this is also where the opportunity for using them in clinical research lies.

Clinical data analysis requires context, which is where the app comes in to play. This is an important dimension to mHealth because of the variety and variable quality of mHealth apps being developed by device manufacturers.

The mHealth initiative has enormous potential for the health and pharmaceutical industries. Properly managed implementation and integration with reliable data repositories is crucial to enabling this emerging trend and opportunity for better, more accurate, more timely data in clinical trial research.

*Guest blogger Ross Rothmeier is a VP of technology solutions, R&D at Medidata. You can reach Ross by email or follow him on Twitter @RossClinCloud.

Five Considerations For Wearable De ...

Craig Lipset leads Pfizer’s clini ...

How Does Risk-based Monitoring Impa ...

[caption id="attachment_1913" align ...

The Data-driven Protocol Design

Dave Gemzik, Medidata’s Princ ...

Finding The Right Drug For The Righ ...

The term “personalized medicine ...

The Promise Of The Digital Health R ...

  The global head of research ...

Ann on Taking ePRO to New Places – Replacing Paper
Excellent article!

David Detwiler on “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"...

Sam on Taking ePRO to New Places – Replacing Paper
Clear and concise description of Patient Cloud cost benefits vs. Paper. Used it today!

Khrystal Davis on 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...

Penelope Manasco on 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...