Forget 2012. What about September 27, 2008? Sure, it’s already passed, but it was an important date for the pharmaceutical industry. And it affects you now.
On September 21, 2008, U.S. Public Law 110-85 went into effect. Title VIII, Section 801 of this law requires pharmaceutical companies performing studies with drugs that will be subject to FDA regulation to register the trials and report summary results data on the ClinicalTrials.gov Protocol Registration System (To read more about the requirements, visit the Protocol Registration System General Requirements page).
Is having to post results from early phase trials on ClinicalTrials.gov making you nervous?
It shouldn’t. Now is a time when physicians are demanding more transparency. They are cynical about the information presented to them by sales reps and pharmaceutical companies. They even question the validity of published articles because research is sponsored by pharmaceutical companies. Yet here is the opportunity to get you data out to physicians on a broad scale at a very early date. You don’t have to detail the physicians. You just have to be sure they hear about the trial and visit ClinicalTrials.gov to read the results. Consider it free communication. (Very clinical free communication.) You’re gathering the data anyhow, so why not share it?
Worried that this requirement will affect journal publications as we know them? Many members of the International Committee of Medical Journal Editors will not accept articles based on trials that are not registered. And the ability to get articles published by journals may not be affected according to Trish Groves, deputy editor of the British Medical Journal. She wrote the following in a 2008 editorial:
…journals will continue to add value by publishing useful and readable trial reports that clinicians, the media, and patients can interpret and use. And, most importantly, the results disclosed for the FDA will not have been externally peer reviewed and will be preliminary. Peer review not only provides a stamp of quality assurance, it often leads to reanalysis of results.
So as you proceed into this new world of data reporting, try to see the advantages. A drug patent only lasts 20 years, so every minute counts. Why not use this new law to create interest in your drug early in its lifecycle?
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