Category Archives: Clinical Trials

FDA Guidance on Clinical Trials During COVID-19 Pandemic

Posted on March 20, 2020 by Mark Senak

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

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Taking a Peek at Transparency – An FDA Pilot Program

Posted on January 17, 2018 by Mark Senak

Yesterday, Commissioner Scott Gottlieb announced a new effort on the part of the agency aimed at increasing transparency around clinical trials, a goal long sought by many patient advocates, particularly outside the U.S.  Specifically, FDA is introducing a pilot program … Continue reading →

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FDA and Patient Involvement

Posted on July 27, 2017 by Mark Senak

“I am a cancer survivor, I was treated for cancer during my last tour at FDA, so I k now the importance of what American medicine does — and what the FDA does — for every one of us.” Scott … Continue reading →

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NIH Clinical Trials and You

Posted on February 7, 2012 by Mark Senak

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

Posted on January 23, 2012 by Mark Senak

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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