Comments for Clinical Trials Blog from Applied Clinical Trials

Comment on New Patient Group Gets Muted Response—So Far by Philip Ward

Philip Ward — Tue, 21 Feb 2012 06:39:39 +0000

Jan – thanks for your comments and feedback, which I read with interest. My longer article will appear in the March edition of Applied Clinical Trials as a global news story. I wish you good luck over the coming weeks, months and years! Kind Regards. Philip

Comment on New Patient Group Gets Muted Response—So Far by Jan Geissler

Jan Geissler — Mon, 20 Feb 2012 19:49:33 +0000

Dear Philip

thank you so much for sharing your thoughts about EUPATI. We are glad that the project has gained your interest. This 5 year project is certainly ambitious – the patient community is very excited about it. However, it has just started and will first focus on assessing the real need in the patient community and then develop tailored high-quality educational material over the upcoming years. For that reason it will take a while until first results become available. Developing it in seven languages will certainly be a challenge, but given Europe’s diversity with 23 official languages and not everyone being fluent in English, we certainly believe it is a must to cover the major language in order to address it in one of the languages that most European patients can understand….

So please stay tuned for progress, and follow our news on Facebook and Twitter when the project progresses – if you have any questions beforehand, we’re of course happy to answer them.

Best wishes
Jan

Comment on Florida’s New Laws Fight Prescription Drug Abuse by Stephen in Orlando

Stephen in Orlando — Fri, 10 Feb 2012 06:31:50 +0000

This is a big issue in our country. In fact last night, I was watching a special on TV about the trafficking of prescription drugs that is taking place in the U.S. One of the guys being interviewed in jail had even been a doctor. They did mention that Florida was a prime area to get large quantities of prescription drugs to distribute. With new medications being developed in Florida, I feel that it is very important that we govern ourselves accordingly.

Comment on FDA Study Data Standards and Common Sense by Kerstin Forsberg

Kerstin Forsberg — Mon, 06 Feb 2012 19:55:55 +0000

The ODM/XML is one way to exchange clinical data and the metadata describing and tracing clinical data. An alternative is to use base next generation of clinical data standards on the W3C’s RDF (Resource Description Framework) graph model, global identifiers and use for example the RDF/XML representation.

Using global (and also permanent and technology independent) identifiers for each single piece of data so that they can be described and traced across the clinical data life cycle. This is done in other domains, such as for spending data in local UK government, e.g. http://spending.lichfielddc.gov.uk/spend/8605670 identifies one individual payment. This is a so called http-based URI (Uniform Resource Identifier). So, how could a URI look like for one individual observation in a clinical study? In my presentation in the 2011 CDISC Interchange Europe conference 1) you can see some examples (slide 40) for linking clinical data using URI:s

Also, using a data provenance approach to represent a detailed view on the life of a single pieces of data, using standards such as the Provenance Vocabulary 2). This is one of a many modern data standards build upon RDF and URI:s. It could be used to improve traceability for both clinical data creation/capture and for access/derivation.

1) http://kerfors.blogspot.com/2011/05/linking-clinical-data-standards.html
2) http://sourceforge.net/apps/mediawiki/trdf/index.php?title=Guide_to_the_Provenance_Vocabulary

Comment on FDA Study Data Standards and Common Sense by Jozef

Jozef — Sat, 04 Feb 2012 15:38:31 +0000

Submission (SDTM) data IS clinical data, only categorized and reorganized.
For already many years, there is a very well-accepted for exchange of clinical data, which is the CDISC Operational Data Model (ODM).
So why not use ODM for submission of clinical data to the FDA? It is a natural choice, and would make it much easier to streamline the clinical workflow (from protocol to submission), as one can use the same exchange format all the way.

Comment on 2012: Hot Topics by Lisa Henderson

Lisa Henderson — Fri, 27 Jan 2012 19:52:38 +0000

Larry,

You are right. They are competing statements and I guess I didn’t look at it that way. I guess it would be difficult to get back to basics and focus if your workload has doubled. Even in my industry, publishing, is the same. More workloads and less people. Maybe if we at least focus, and not focus on getting it right all the time, but focus on creative solutions that would be a way out of that.

Comment on Your Help Needed on Survey by Lisa Henderson

Lisa Henderson — Fri, 27 Jan 2012 19:49:50 +0000

Stephen T

Thanks for your comments. We have published peer-reviewed articles on this topic before, most recently last August on Clinical Contracting Efficiencies, here http://bit.ly/yK9HSN

And we are really looking forward to the results of this survey. So many companies are trying to target this space–the study start-up delay problems–and coming at it from a variety of ways. It will be interesting to see how this plays out in the next year.

Comment on Your Help Needed on Survey by Stephen T

Stephen T — Thu, 26 Jan 2012 18:03:04 +0000

This is an interesting topic for sure. With the number of clinical trial facilities around the US, there is a constant push for new studies to be undertaken. If they are not able to start up one particular clinical study on time, this can definitely through future projects out of place. It's really important in this industry to be able to have as quick start up abilities as possible. It's unfortunate that site agreements can be such a hindering factor sometimes.

Comment on Merck Releases First-Ever Approved Diabetes-Cholesterol Pill by Valeri Cimorelli

Valeri Cimorelli — Thu, 26 Jan 2012 17:24:27 +0000

I really like your post, thank you for sharing it.

Comment on 2012: Hot Topics by Larry Broach

Larry Broach — Thu, 19 Jan 2012 14:20:30 +0000

There are two competing statements in your article. “The net trickle down effect is increased workloads on fewer people” and “get it done right and well the first time”. With fewer people working on more, it will be difficult to get it right the first time. There will be corner cutting in more places with less time to focus on the end game. I hope management is ready for this net effect.