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Paul Ivsin
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REMOTE Redux: DTP trials are still hard
Maybe those pesky sites are good for something after all.  It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information ...

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Retention metrics, simplified
[Originally posted on First Patient In ] In my experience, most clinical trials do not suffer from significant retention issues. This is a testament to the collaborative good will of most patients who consent to participate, and to the patient-first attitud...

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The Streetlight Effect and 505(b)(2) approvals
It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting ...

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Establishing efficacy - without humans?
The decade following passage of FDAAA has been one of easing standards for drug approvals in the US, most notably with the advent of “breakthrough” designation created by FDASIA in 2012 and the 21st Century Cures Act in 2016. Although, as of this writing, t...

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Jerry Matczak
Jerry Matczak passed away suddenly last Thursday at the much-too-young age of 54. I can say, without exaggeration, that Jerry embodied pretty much everything I aspire to be in my professional life. The MedCityNews headline called him a “social media guru”, ...

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The first paid research subject in written history?
On this date 349 years ago, Samuel Pepys relates in his famous diary a remarkable story about an upcoming medical experiment. As far as I can tell, this is the first written description of a paid research subject. According to his account , the man (who he ...

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Will texting your spouse make you a better trial participant?
It is
becoming increasing accepted within the research community that patient
engagement leads to a host of positive outcomes – most importantly (at least practically speaking) improved
clinical trial recruitment and retention. But while we
can all agree th...

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Waiver of Informed Consent - proposed changes in the 21st Century Cures Act
Feuerstein points out - and expresses considerable alarm over - an overlooked clause in
the 21 st Century Cures Act: Waive informed consent requirement for clinical trials?!?! Unbelievable but true if #Path2Cures becomes law.

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Patient Centered Trials - Your Thoughts Needed
The good folks down at eyeforpharma have asked me to write a few blog posts in the run-up to their Patient Centered Clinical Trials conference in Boston this September. In my second article - Buzzword Innovation: The Patient Centricity “Fad” and the Token P...

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Pharma Disruption Watch
I have to admit to maybe being a little unsure about the " Dpharm: Disruptive Innovations to Advance Clinical Trials "  conference.   A more cynical man than I might look at the high entry price, the posh venue, and the perhaps-somewhat-predictable list of ...
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