Tuesday, October 29, 2013

How should public access to clinical trial data be handled?

Have more access to data and information from clinical trials can improve care.  So what can health agencies across the world do to allow access to more data from clinical trials that is provided when drug companies submit their drugs for approval?  In a recent article from FinChannel.com, they look at the European Union's look to expand the public access of data from clinical trials while keeping privacy and managing the best interest of Pharmaceutical companies in tact.

In Europe, it has been announced that the European Medicines Agency will allow public access to clinical trials data provided in the submissions from the Pharmaceutical companies provided during the marketing approval process.  The EU sees this as an opportunity as two-fold:  It would allow scientists to check the efficacy and safety reported from the drug companies and would allow for scientists to go beyond the original scientific study.

Harvard University, the publishers of the study, suggest that in the future, clinical data could be expanded releasing data for approved prescription drugs, medical devices and biologics.  Drug companies in Europe are in a fierce debate over whether or not allowing access to clinical trial data is something that is proprietary and something that shouldn't be shared with their competitors.  

This March at Partnerships in Clinical Trials, we'll have a number of sessions that looks at the influx of data that is coming from clinical trials and how companies can make the most of it.  For more information on this year's event, sign up for email updates.  If you'd like to join us March 30-April 2, 2014 in Las Vegas, as a reader of this blog, you can register to join us and mention code XP1900BLOG to save $100 off the current rate!

So where is the happy median?  What do you see as the benefits and downfalls of releasing clinical trial data to the public from both a Pharmaceutical company's view and the view of a scientist who could find ways to make the drug more valuable to the public?

1 comment:

Stephen Trevathan said...

Yea, this really is an interesting topic of debate. As you may already know, there are plenty of clinical trials which are testing these complimentary therapies for a wide range of diseases and conditions, especially cancer. I'd like to think that full access would be handled well by the public, but I don't believe that would be the case unfortunately. Thanks for sharing.