Tuesday, August 27, 2013

Could unlocking past clinical trial data lead to better insights?

In a recent blog post by Tania Browne at SciLogs, she looks at the information available at the clinical world's fingertips to make clinical trials better and more informative for everyone. But there's one major setback. Data is not being made readily available to the public to learn from. The most common ways to retrieve data now are though journal publications and trial registries, but there is so much more data below the surface that can allow doctors and patients to truly understand the drug, it's clinical trial and the way it works for humans.

Browne points to four things that can make clinical trial data more understandable and better usable for doctors, patients and others in the clinical trial community. Registration is key for all clinical trials. She goes beyond just simply registraign all trials going forward but also points to trails that took place that took before this regulation was in place - such as the trials for high blood pressure and aspirin. What information could be gathered from the now-standard information such as the protocol, information about participants and their informed consent, the intervention being investigated.

Summaries are also something that should be available - for both completed and abandoned trials.  Of the 635 clinical trials completed by 2008, only 20% had released a summary within a year.  The median average for a summary being completed was 51 months, over four years.  Browne suggests that companies who are producing full reports internally should share those publicly.

The conclusion of the article is that so many healthcare decisions are being made with out the data that is available.   All Trials is trying to push this matter to help this information go public.  Pharma companies have the data and should make it public so that consumers and physicians have a better understanding of where the medications come from, what the side effects are and quite possibly why it is or isn't a medication that should be used.

This fall at the Clinical Collaboration Congress., Conference Chair Kenneth I. Kaitin, PhD, Professor and Director, Tufts Center for the Study of Drug Development Tufts University School of Medicine will be on hand to present Improving the Drug Development Process through Risk-Sharing Collaborations which will look at how using pre-collected data can impact the Pharma indstury in a positive way and make the research process more effective, stable place for drug innovation. The Clinical Collaboration Congress will take place this September 25-27, 2013 in Boston, MA. For more information on Ken's presentation and the rest of the program, download the agenda. If you'd like to join us, as a reader of this blog, when you register to join us and mention priority code XP1825BLOG, you'll save 15% off the standard rate.

Do you think it would be beneficial to the industry to release the data from previous clinical trials to the public?  Why or why not?




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