From the LaunchPad

Welcome to The Launchpad, SoundRocket’s blog, where we share our insights and musings on the science of doing science (well), #soundscience.

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Decoding FDA DTC Policy: Part 3 – The November 1 Warning Shots

Decoding FDA DTC Policy: Part 3 – The November 1 Warning Shots

One day following the Personal Genome Service Pharmacogenetic Reports (PGSPR) approval release, on Thursday, November 1, 2018, Jeffrey Shuren, M.D., J.D. (the Director of the FDA’s Center for Devices and Radiological Health), together with Janet Woodcock, M.D., (the Director of the FDA’s Center for Drug Evaluation and Research) published a statement to warn “consumers about genetic tests that claim to predict patient’s responses to specific medications.”  This statement specifically calls out tests…

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Decoding FDA DTC Policy: Part 2 – What are user comprehension studies? And are pharmacogenetic test report requirements different than previous FDA regulations?

Decoding FDA DTC Policy: Part 2 – What are user comprehension studies? And are pharmacogenetic test report requirements different than previous FDA regulations?

What Are User Comprehension Studies and Why are they Required by the FDA?

Unlike tests that are overseen by health care professionals where a conversation may take place about the meaning of results, direct-to-consumer tests bypass the traditional patient-doctor relationship and deliver results directly to patients (or consumers).  A well-known example of a direct-to-consumer test is a pregnancy test that one may purchase at any pharmacy or similar retail store…

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Decoding FDA DTC Policy: Part 1 – Pharmacogenetics Are Here!

Decoding FDA DTC Policy: Part 1 – Pharmacogenetics Are Here!

While many of us were heading out to dish out candy (or tricks) to local goblins and superheroes this past Halloween, the FDA rounded out their suite of De Novo reclassification orders on DTC genetic testing.  The latest announcement adds Personal Genome Service Pharmacogenetic Reports (PGSPR) to the existing regulations for Carrier Screening and Genetic Health Risk (GHR) tests (including a specific case of Genetic Health Risk Report for BRCA1/BRCA2)…

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Assessing event-based college student drinking and social context using mobile devices

Assessing event-based college student drinking and social context using mobile devices

Most surveys of alcohol-use ask about behaviors and patterns that happen days, weeks months or even years ago. It’s all retrospective recollection from study participants. It’s useful for identifying general trends but it’s fraught with measurement errors.  And when the topic of the study is binge drinking, errors involving memory can increase. — even if you’re asking the question the next day.

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Examining the Feasibility of Using SMS When Surveying College Students

Examining the Feasibility of Using SMS When Surveying College Students

ext messages (also known as Short Message Service, or SMS) are more and more becoming the go-to medium of communication. This especially is the case for today’s college students, who seem to conduct their social and even business lives completely via their smartphone.

Scott Crawford and the team at SoundRocket looked at the data surrounding the efficacy of using SMS when surveying college students, resulting in a presentation at the 2013 American Association of Public Opinion Research (AAPOR) Conference.

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Why We Do Checklists

Why We Do Checklists

It has been a while since I have communicated about the importance of checklists.  It feels that the time is right to do so again… as it will become a more and more important element to what we do as we grow.

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