08 Apr 2015

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

by Ross Rothmeier

InternetOfThings2
What? Sending data to the cloud without needing a tablet, laptop, smartphone?

Yes!
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:

InternetOfThings1InternetOfThings3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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:

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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.

01 Apr 2015

Entering Data After Patient Visit — Clinical Research Sites Best Practices

by Christine Pierre

Christine Pierre is the president for the Society for Clinical Research Sites (SCRS). We caught up with Christine at this year’s SCOPE Summit, where we talked about site sustainability and how SCRS has been working with other industry stakeholders to identify best site practices. In this video, Christine discusses creating efficiencies at sites, when it comes to the entering of data following a patient’s visit.

*Christine Pierre is president of the Society for Clinical Research Sites (SCRS), a global trade organization representing over 2,000 clinical research sites in 39 countries. Follow@MySCRS on Twitter.

TWEET THIS:


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26 Mar 2015

The Quality by Design Aspects of Risk-Based Monitoring — SDV, SDR and the Role of the CRA

by Geeks Talk Clinical

Part of laying the foundation for a successful risk-based monitoring (RBM) program is training clinical research associates (CRAs) on what data needs to be reviewed on site, and how much of it. (more…)

19 Mar 2015

One Patient’s Clinical Trial Experience: “It’s Not Just a Document. It’s a Life.”

by Geeks Talk Clinical

T.J. Sharpe is a cancer survivor turned patient advocate. While trying to enroll in a research trial that could essentially save his life, T.J.’s clinical trial agreement just sat on a lawyers desk  waiting to be executed. But as a Stage 4 melanoma cancer patient, T.J. didn’t have much time. His only option was to advocate on his own, in order to get through all of the red tape. (more…)

12 Mar 2015

What Advocates Said to Congress During Rare Disease Week on the Hill

by Steve Smith

SteveSmithRare Disease Week on Capitol Hill, February 23-27, 2015

Several hundred new rare disease treatments could be approved in just a few years; previously, that has taken decades.

Elevator Pitch from Rare Disease Advocates to Capitol Hill

Helpful Legislation Proposed in 21st Century Cures Draft

In late January, the U.S. House of Representatives Energy and Commerce Committee issued its draft discussion document. The line items are proposed to become laws that could transform drug research, development, and delivery. Advocates studied this legislation and then went to Capitol Hill last week and met with legislators. (more…)

06 Mar 2015

Translating Quality and Risk Assessment for Risk-Based Monitoring at SCOPE Summit

by Kyle Given

This year, SCOPE Summit hosted the Cambridge Healthtech Institute’s inaugural conference “From QbD and Risk Assessment to Risk-Based Monitoring (RBM) — Laying the Foundation.” Medidata’s Kyle Given moderated one of the sessions, featuring Boehringer Ingelheim’s Andy Lawton and CRA Consultant Mary Mills. In this video recap, Kyle shares his takeaways and why he believes that RBM is the wave of the future when it comes to clinical trials’ execution. (more…)

27 Feb 2015

Rare Disease Week on Capitol Hill

by Steve Smith

FrancisCollins__NlPatient advocates convened on Capitol Hill Feb 23-27 for Rare Disease Week. I was honored to meet with fellow advocates, orphan drug company representatives and members of Congress who we urged to support the new draft 21st Century Cures legislation. This draft discussion document was just issued in January by the House Energy and Commerce Committee. The essence of that proposed legislation is to put patients in the center of drug development, to modernize the process by which we regulate drug development and to free data from its silos by creating a 21st Century Data Infrastructure, among other transformative changes needed in the “path to cures.” (more…)

20 Feb 2015

A Conversation on US-East Asia Pharma Collaboration

by Bryan Spielman

IMG_1671Last week, I attended a conference on US-East Asia pharma collaboration at the Yale Club of New York City. Hosted by the New York Pharma Forum and the New York Health Forum, both organizations focus on creating and furthering opportunities for global pharmaceutical industry collaboration and development. I was delighted to join panelists Les Funtleyder, portfolio manager at Esquared Asset Management, and Debra Yu, managing director at Labrador Advisors, for the discussion, “Fitting into the Ecosystem: New Sustainable Strategies of Collaboration.” We talked about building successful partnerships among pharma and biotech companies from China, Korea, Japan and the US. (more…)

12 Feb 2015

Transforming Clinical Development One Study at a Time

by Geeks Talk Clinical

The life science industry is under pressure. As key patents are expiring, pharma and biotech companies are challenged to bring new and better treatments to patients. Clinical trials are vital for proving safety and efficacy – but they’re long, complicated and expensive. (more…)

06 Feb 2015

The Future of Clinical Trials… A Look Back at Symposium Europe with Service Partner Wincere

by Himanshu Kansara

Video interview with Himanshu Kinsara, managing director at Wincere, on his key takeaways from our Medidata Symposium Europe. Having attended his seventh user group meeting late last year, Himanshu discusses what keeps him coming back, why he thinks risk-based monitoring is the future of clinical trials, and new initiatives at Wincere. (more…)

30 Jan 2015

Collecting Clinical Data, RBM, Study Design and More… Medical Device and Pharma Perspectives

by Nurcan Coskun

How are clinical studies conducted by medical device companies different from pharma studies? Is the way clinical data is collected or risk-based monitoring and critical processes conducted similar? Medtronic International’s Nurcan Coskun shares her thoughts, in this video conclusion.

Watch Part 1 of our video interview with Medtronic International’s Nurcan Coskun. (more…)

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The Internet of Things (IoT) and Cl ...

What? Sending data to the cloud w ...

Entering Data After Patient Visit ...

Christine Pierre is the preside ...

The Quality by Design Aspects of Ri ...

Part of laying the foundation f ...

One Patient's Clinical Trial Experi ...

T.J. Sharpe is a cancer survivo ...

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