Tag: Clinical trial

FDA issues final rule on safety information during clinical trials

This is an interesting announcement and reveals to me the fact that the FDA is coming to grips with the fact that the current process for reporting adverse events needs an overhaul including refining what qualifies as an AE and how they are reported. I believe the landscape for AE reporting is about to change dramatically owing to another trend which is quite outside the FDA’s control, namely social media. A number of articles show that due to the growth of online medical communities and web 2.0 means of sharing science and medical knowledge, the idea of capturing AEs via phone call or other report to a drug company from an HCP is becoming increasingly obsolete. Reportable adverse events are far less common than most people suspect. As of 2009 there were only approximately 166 reportable adverse events per day recorded across the entire pharma industry. Increasingly pharma companies are examining how (and to what extent) they will be required to capture and monitor AEs in online discussions occurring on their brands. The amount of content to monitor is potentially staggering and yet algorithms are being developed that will automate this to some extent. This has the potential to be much more useful than simply tracking isolated AE incidents for the FDA since it will allow both regulators and industry to gain much more sophisticated intelligence on the experience of mass numbers of customers with the products.

References
http://www.eyeonfda.com/eye_on_fda/2009/07/change-coming-to-pharmacovigilance.html
http://www.doseofdigital.com/2009/12/monitoring-adverse-events-social-media-pharmas-biggest-brands/
http://www.nakedmedicine.com/how-useful-is-social-media-in-pharmacovigilance
http://www.slideshare.net/johnmackjr/jmack-smandae-rfuturewdsc2010

Related articles

• The Changing Landscape of Postmarketing Safety Reporting (ask-cato.com)
• The State of Drug Safety Surveillance in the U.S.: Much Improved, More to Come (brookings.edu)
• Is FDA keeping social media from taking flight in pharma? (fiercebiotechit.com)
• Drug side effects via social media (worldofdtcmarketing.com)
• FDA Issues New Cautionary Guidelines for Metal-on-Metal Hip Implants, Parker Waichman LLP Reports (prweb.com)
• FDA Gives Nod to Celgene For Multiple Myeloma Drug ‘Pomalyst’ (guardianlv.com)
• Pharma cannot afford to ignore social media (pharmastrategic.com)