Welcome to my website. Here I’ll be sharing my thoughts on improving clinical research in my blog, as well as posting observations on data standards, technologies, innovations and other current developments in the clinical research world. For those of you who’ve been watching some of my presentations in recent years, I’m also sharing my reading…
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Reimagining Research – Thoughts on Improving Clinical Research | waynekubick.com Reviews
https://waynekubick.com
Welcome to my website. Here I’ll be sharing my thoughts on improving clinical research in my blog, as well as posting observations on data standards, technologies, innovations and other current developments in the clinical research world. For those of you who’ve been watching some of my presentations in recent years, I’m also sharing my reading…
waynekubick.com
The “Cubs Way” to Future Submission Data Standards – Reimagining Research
https://waynekubick.com/2015/10/29/the-cubs-way-to-future-submission-data-standards
Thoughts on Improving Clinical Research. The Cubs Way to Future Submission Data Standards. October 29, 2015. October 30, 2015. Even for those who don’t follow baseball, you must have heard something about the storybook year of the out of nowhere Chicago Cubs in 2015. No, they’re not going to win the 2015 World Series, but they made the Final Four, and somehow, that didn’t feel like losing this time around. Think long term with a plan. Keep meeting current needs (but only to a point). Fill in the missing ...
Playing with FHIR® – Reimagining Research
https://waynekubick.com/2016/08/04/playing-with-fhir
Thoughts on Improving Clinical Research. August 4, 2016. August 17, 2016. A standard is not used because we created it. It is a standard because people use it. This familiar quote from Dr. Chuck Jaffe, CEO of HL7, could have been the motto for the inaugural FHIR Applications Roundtable. Meeting held last week at Harvard Medical School in Boston. As so many of the smiling attendees attested, this was indeed a very different kind of meeting. What was most impressive was that this roundtable only scratched ...
CDISC – Reimagining Research
https://waynekubick.com/tag/cdisc
Thoughts on Improving Clinical Research. Dear CFAST: Please Slow Down to Catch Up. January 18, 2016. January 20, 2016. A new year and many new things to think about in the greater world of research and healthcare, though there are still plenty of unfinished thoughts about CDISC to expound upon. In my last post, I tried to sum up my thoughts on SDTM. To addressing gaps in the model, especially for the CFAST Therapeutic Area User Guides (TAUGs). And today, I’d like to echo the slow food movement. Putting t...
HL7’s FHIR and BioPharma – Reimagining Research
https://waynekubick.com/2016/05/06/hl7s-fhir-and-biopharma
Thoughts on Improving Clinical Research. HL7’s FHIR and BioPharma. May 6, 2016. I’m finally beginning to get back in the swing of blogging, after a long hiatus getting ramped up at my new job as HL7 CTO. Here are a few thoughts on the HL7 FHIR standard, and how it may help reimagine clinical research in the Biopharmaceutical industry. EHR eSource: Sword of Change? Leave a Reply Cancel reply. Enter your comment here. Fill in your details below or click an icon to log in:. Address never made public). HL7&#...
Dear CFAST: Please Slow Down to Catch Up – Reimagining Research
https://waynekubick.com/2016/01/18/dear-cfast-please-slow-down-to-catch-up
Thoughts on Improving Clinical Research. Dear CFAST: Please Slow Down to Catch Up. January 18, 2016. January 20, 2016. A new year and many new things to think about in the greater world of research and healthcare, though there are still plenty of unfinished thoughts about CDISC to expound upon. In my last post, I tried to sum up my thoughts on SDTM. To addressing gaps in the model, especially for the CFAST Therapeutic Area User Guides (TAUGs). And today, I’d like to echo the slow food movement. Putting t...
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Thoughts on Medical Informatics: Deciding When to Change the SDTM
http://aolivamd.blogspot.com/2016/08/deciding-when-to-change-sdtm.html
Thoughts on Medical Informatics. Deciding When to Change the SDTM. I frequently come across proposals to change or upgrade the SDTM. Experience has shown that changes to the SDTM are a big deal. That hopefully will result in a more stable standard (see my previous post. We recognize that some change is inevitable, but change that can be accomplished through other means should be pursued. Stakeholders need a stable standard. Here are some working definitions:. Here I use the HIMSS definition. A good excha...
Thoughts on Medical Informatics: September 2016
http://aolivamd.blogspot.com/2016_09_01_archive.html
Thoughts on Medical Informatics. Rethinking the Three CDISC General Observation Classes. Please note this post has been updated to reflect updates to some clinical definitions referenced in this post. The links have been updated as well. These do not change the overall message and conclusions. The CDISC Study Data Tabulation Model ( SDTM. Here are some thoughts. I certainly welcome comments. The Events class . captures planned protocol milestones such as randomization and study completion, and occurr...
Thoughts on Medical Informatics: March 2016
http://aolivamd.blogspot.com/2016_03_01_archive.html
Thoughts on Medical Informatics. Distinguishing Clinical Observations and Medical Conditions. As the pharmaceutical industry moves quickly towards standardized clinical study data, I continue to see confusion in how clinical observations and medical conditions are represented. In clinical medicine there is a sharp distinction between these two concepts, yet in standardized study data submissions they are often lumped together. Herein lies the major distinction between clinical observations and medical co...
Thoughts on Medical Informatics: Distinguishing Clinical Observations and Medical Conditions
http://aolivamd.blogspot.com/2016/03/distinguishing-clinical-observations.html
Thoughts on Medical Informatics. Distinguishing Clinical Observations and Medical Conditions. As the pharmaceutical industry moves quickly towards standardized clinical study data, I continue to see confusion in how clinical observations and medical conditions are represented. In clinical medicine there is a sharp distinction between these two concepts, yet in standardized study data submissions they are often lumped together. Herein lies the major distinction between clinical observations and medical co...
Thoughts on Medical Informatics: Aristotle and How Best to Define Things
http://aolivamd.blogspot.com/2015/12/aristotle-and-how-best-to-define-things.html
Thoughts on Medical Informatics. Aristotle and How Best to Define Things. The great challenge in automating analysis of biomedical data is the fact the people use different words for the same thing and the same word for different things. Having clear, unambiguous definitions, or semantics, is of course critical. I wrote a bit about this in a post on the Interoperability Problem. Also in a previous post. It turns out that the Open Biomedical Ontologies. Provides an Ontology for Biomedical Investigations.
Thoughts on Medical Informatics: Rethinking the Three CDISC General Observation Classes
http://aolivamd.blogspot.com/2016/09/rethinking-three-cdisc-general.html
Thoughts on Medical Informatics. Rethinking the Three CDISC General Observation Classes. Please note this post has been updated to reflect updates to some clinical definitions referenced in this post. The links have been updated as well. These do not change the overall message and conclusions. The CDISC Study Data Tabulation Model ( SDTM. Here are some thoughts. I certainly welcome comments. The Events class . captures planned protocol milestones such as randomization and study completion, and occurr...
Thoughts on Medical Informatics: October 2016
http://aolivamd.blogspot.com/2016_10_01_archive.html
Thoughts on Medical Informatics. Definition of Common Clinical Terms v2. I proposed some working definitions of common clinical terms. Since then additional thinking and feedback has led to some refinements. I'm reposting and cross-referencing the two versions. The changes are highlighted in bold and red. We all use these words in clinical medicine: observations, assessments, diagnosis, medical condition, adverse event, outcome measure, endpoint. But what do they really mean? I have come up with the foll...
Thoughts on Medical Informatics: Observations, Assessments, and BRIDG
http://aolivamd.blogspot.com/2015/08/observations-assessment-and-bridg.html
Thoughts on Medical Informatics. Observations, Assessments, and BRIDG. In a previous post, I discussed my view of how clinical data are generated and used (see Modeling Clinical Data. I discussed the differences between an observation and an assessment. This is an important distinction in clinical medicine. Eg 30-4.5 mg/dL). Are there other clinical observations suggesting clinical hyperkalemia (e.g. EKG findings)? Could it be laboratory error (is a repeat measurement necessary)? An important clinical di...
Thoughts on Medical Informatics: August 2016
http://aolivamd.blogspot.com/2016_08_01_archive.html
Thoughts on Medical Informatics. Deciding When to Change the SDTM. I frequently come across proposals to change or upgrade the SDTM. Experience has shown that changes to the SDTM are a big deal. That hopefully will result in a more stable standard (see my previous post. We recognize that some change is inevitable, but change that can be accomplished through other means should be pursued. Stakeholders need a stable standard. Here are some working definitions:. Here I use the HIMSS definition. A good excha...
Thoughts on Medical Informatics: December 2015
http://aolivamd.blogspot.com/2015_12_01_archive.html
Thoughts on Medical Informatics. Aristotle and How Best to Define Things. The great challenge in automating analysis of biomedical data is the fact the people use different words for the same thing and the same word for different things. Having clear, unambiguous definitions, or semantics, is of course critical. I wrote a bit about this in a post on the Interoperability Problem. Also in a previous post. It turns out that the Open Biomedical Ontologies. Provides an Ontology for Biomedical Investigations.
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WAYNE K. SPEAR You have my word on it. Right Brain. Left Brain. August 10, 2015. Today the technocrat, tomorrow the artist. By Wayne K. Spear. The historian looks backward in time to understand the present. The lawyer argues from precedent. Technocrats study the world as it is and apply rational, systems thinking to their endeavors. Interpretation, argumentation, and rational systems thinking. Imagination is an act of will. To create something from nothing is to choose a radical form of human freedom.
Reimagining Research – Thoughts on Improving Clinical Research
Thoughts on Improving Clinical Research. Since I’ve joined HL7 as CTO effective Feb. 28, 2016, I’ll be posting somewhat less frequently on this site for awhile. But I’ll try to keep updating the reading list and also posting links to other things I’ll be producing with HL7. Stay tuned for more to come and follow me on Twitter at @WayneKubick and on Linked In at https:/ www.linkedin.com/in/waynekubick. Effectively applying today’s data standards not just for compliance but to realize time and cost benefits.
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