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…
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.
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…
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)…
The Science of Direct-to-Consumer Genetic Testing – SoundRocket Partners With Academics and Industry to Understand How Genetic Information is Used
And if you could take a genetic test to determine if you have the gene mutations that could show you have an increased risk of having Alzheimers Disease, would you? As the U.S. FDA has started regulating and approving these tests, SoundRocket asks: are there any potential harms and limitations?
An oldie but a goody!
Care should always be taken to only use previous data when it is methodologically important to do so. Here are the 5 times that reusing data to enhance your survey is actually ok.
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.
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.
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.
Gathering data for direct-to-consumer personal genomic testing made easier with SoundRocket as data collection partner
This was the first experience for any researchers to look closely at the impact of personal genetic testing reports – to see how users understood them and made use of the results they provide. Soundrocket was happy to play a role in this important research.