Action Items

How to run a successful clinical trial for embolic protection devices

Friday, December 1, 2017

Because of the surge in the use of embolic protection devices (EPDs), the market for these devices is expected to grow into a billion-dollar industry. EPDs may protect patients from serious neurological damage that could occur during transcatheter aortic valve replacement (TAVR) procedures; they are designed to catch or divert valve debris that may travel to the brain. EPDs are commercially available in Europe, and the FDA cleared an EPD for the first time last June.

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Everything you wanted to know about a clinical research site but were too afraid to ask

Friday, December 1, 2017

Clinical research is intense. Deadlines are tight.  Protocols are complicated.  But we all have the same goals: deliver safe and effective medications to patients who need them. Sometimes sites, monitors, CROs and sponsors collectively forget that there are human beings behind every email, but that’s what every site has to keep in mind if the principal investigator wants a successful trial.  Here’s what else you should know about working with sites.

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Patient engagement key to improving Alzheimer’s study success rates

Friday, December 1, 2017

Alzheimer’s disease (AD) is the most common cause of dementia, contributing to 60% to 80% of cases. By 2050, the Alzheimer’s Association expects the number of people diagnosed with dementia to increase from 46.8 million to 131.5 million. There is a clear need for continued drug development in this area. 

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The Gold Rush and Monopoly Land grab in eClinical growth

Wednesday, November 1, 2017

In 2015, the global eClinical software market was forecasted to reach $6.8 billion by 2020. Recent research now doubles that estimate by 2024. The global increase in clinical trials is driving this growth, as the industry evolves from its slow paper-based methods and standalone spreadsheets toward automated, cloud-based systems to confront the oft-mentioned costs of drug development.

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Increasing participation in clinical trials among underrepresented populations

Wednesday, November 1, 2017

Reaching under-represented populations has been a challenge to clinical trial patient recruitment for years. Sponsors, CROs, recruitment vendors and sites have all struggled to find the right approach for reaching these diverse groups. While these target audiences are not necessarily small, they each have unique characteristics that can make it more difficult to engage them in the clinical trial process.

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Pay clinical trial patients back with lay language summaries

Wednesday, November 1, 2017

How do you thank someone for taking part in a clinical trial? Evidence is mounting that an effective way to thank study volunteers is to provide them with a plain-language summary of the trial results. Plain, or lay-language summaries, distill the findings of the clinical trial into a brief summary that is understandable to the general public. Various studies show that most participants want the results of their trial but they are not consistently receiving them. In addition to the results, plain-language summaries provide participants with a greater general understanding of the trial. Providing these summaries is shown to improve the overall satisfaction with trials and a higher likelihood for future clinical trial participation.

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Smart video conferencing a CNS diagnostic tool for CROs

Monday, October 2, 2017

For the past 20 years, we have watched cell phones morph into smart devices that do just about any function you can name. In this same converging trend, video conferencing systems now include “Smart” technologies enabling a multitude of functions to be performed beyond the legacy video conference function. Today, a CNS diagnostic tool has been created specifically for CRO usage using video conferencing.

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New evidence extends validation for quality review

Monday, October 2, 2017

The Good ReseArch for Comparative Effectiveness (GRACE) checklist is a simple 11-item tool that considers the study purpose and provides questions to guide high-level evaluation of methods, data quality and analytics for use in health technology assessments of effectiveness and safety studies. It provides a scoring tool to help evaluate studies in the context of the study goal, and can be used by sophisticated and less experienced users.

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