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.

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.


Christine Pierre-SCOPE-SCRS-Thumbnail1

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…)

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