Managing Clinical Trials

EDC: Worth the investment in phase I trials?

This month, Clinpage is publishing a special report, “CROs, EDC Get Into The Flow,” about the evolving relationship between these two industries.  Each Friday, they’re posting a new article in the series and will publish a downloadable PDF to wrap it up at the end.

Not so long ago, the CRO and EDC industries viewed each other with skepticism and perhaps a bit of fear.  Could the technology truly accelerate the data collection process, or could it put complex trials at risk?  Would the EDC industry expand and start competing with CROs on their own turf?  And would sponsors react positively or negatively to EDC technology and its costs?

Fortunately the wariness has turned to enthusiasm and real progress.  Today, CROs are forging more formal, integrated partnerships to efficiently capture the complex data needed in today’s clinical environment.  As Clinpage puts it, “In the healthiest CRO-EDC partnerships, the goal is to let a services organization do what it does best, and let a technology organization do what it does best.”

Naturally EDC comes with a price tag:  technical specifications, custom database development, forms, business processes and reports.  While sponsors understand the value of EDC for large phase III trials, many CMOs don’t realize that EDC is a viable option for phase I or II studies. Benefits to consider:

• Real-time results:  Many CMOs need real-time data from a promising drug, and using EDC gives them the data and knowledge they need to react quickly.  This knowledge is often worth the incremental investment in EDC.
• Leverage:  CMOs can mitigate EDC costs by leveraging the technology over an entire drug platform.  If a sponsor plans for EDC for each phase I trial and standardizes CRFs, it can amortize the cost across multiple trials.

Thus, by planning for EDC up front, it’s possible for a sponsor to have the best of both worlds – real-time data at a paper-based cost – even on a phase I trial.

Medelis offers sponsors the ability to conduct phase I trials using EDC or paper forms as desired. Our data management partner, Veristat, has deep experience using EDC even in phase I oncology trials, having handled over 12,000 subjects during EDC trials.

If you’re interested in learning more about the benefits of EDC during phase I, please feel free to contact us.

FDA Commissioner Launches A Blog

FDA Commissioner Andy von Eschenbach has joined the blogosphere with a new weekly column, "Andy's Take," for the American public. 

In his inaugural post, he explains, "As Commissioner, I want to give you my take on some of the events about food and medical products that you have been hearing about in the news.

"I want to give you the inside story on some of the things that will soon be announced at the FDA so that you have my insights about why these initiatives are of such great importance to protecting and promoting your health," he continues.

So far, he has written about heparin, integrated medical products, and liquid dietary supplement products that contain hazardous levels of selenium.

The blog also offers audio versions of the posts, and you can sign up to receive new articles via email.