Category Archives: Clinical Trials

NIH Clinical Trials and You

For a long time, I have thought that clinical trial information was too clinical to be of much use for patients who might be considering entering one.  The information available was either in the form of searchable data bases, text … Continue reading

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Clinical Trials and Search

You are sitting in the doctor’s office on that crinkly paper that pops every time you move. Your physician is leaning against a table and has just uttered some words that were a diagnosis.  It is a serious diagnosis.  For … Continue reading

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Clinical Trials and Social Media – Part 1 in an Intermittent Series

Last week Brian Reid wrote an excellent piece on the Common Sense blog entitled “The 5 Consequences of the Lack of FDA Social Media Guidance“.  He got off to a great start, but I actually think there are many more … Continue reading

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Adolor Corp. Gets Approvable Letter

Today Adolor Corp. announced receipt of an approvable letter from the FDA requesting 12-month safety data that includes an analysis of any cardiovascular related adverse events.  The application was for Entereg, indicated for the management of postoperative ileus.  Share this:

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Adaptive Clinical Trials Workshop – An Opportunity Gone South

Back in July when Dr. Scott Gottlieb made a speech before the American Medical Association and made a lengthy reference to a November workshop in which FDA would participate regarding adaptive clinical trials, there was a great deal of anticipation … Continue reading

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