Evidence & Performance Blog

We almost all know what CDISC is. It is a consortium that develops and maintains clinical data standards, like SDTM (Study Data Tabulation Model) and ODM (Operational Data Modeling).

The purpose of SDTM is to store clinical trial data, in XPT format together with standardized and organized metadata.

The purpose of ODM is to store not only clinical data, but also all data belonging to clinical trials (protocol, queries, DCF, data, metadata, audit-trail …) in XML format.

On the other hand we have the HL7 standard. Standardized messages related to the electronic patient file used to exchange patient data across the hospital structure. Typically a record could contain patient’s information, their consultations, their prescriptions etc…

Those two different worlds try to get closer to each other; in fact they deal with the same information, because some of the clinical data is already captured in the patient’s record. It would be a high benefit if some data coming from the hospital could already be integrated in the clinical trial.

The BRIDG Model has been designed to link both clinical research data and patients file data.

Of course, both standards are quite different, so the challenge lies in the integration of one standard with the other.

Initiated a couple of years ago, the BRIDG project demonstrates that data integration is not easy, and cannot be done over a night.

But what will be done in a long term period? Keep both entities and bridge them together? Wouldn’t it be more profitable to have a unique standard for both? But is it feasible?

More information can be found here: HL7, CDISC, BRIDG.

Additional information can also be found here: http://www.clinpage.com/article/the_future_of_odm_sdtm_and_cdisc/C12

The 6th annual conference will take place in London from January 27th to 29th, 2009!
We are of course looking forward for this unique event in Europe, as its focus is Performance, and Metrics used to accelerate development, improve quality and streamline decision making.

By joining the performance metrics event, you will:
- benefit from the experience of top pharmaceutical companies like JnJ, AstraZeneca, Eli Lilly, Astellas Europe, Baxter, Bayer, CMR (Center for Medicine Research) !
- understand how the implementation and application of performance metrics can improve your clinical trials
- benchmark your performance metrics procedures: gain vital advice from leading pharmaceutical companies from across Europe and globally
- keep up-to-date with the latest performance metrics issues including using metrics to predict risk

We are very pleased to announce that we will be joining the event, not only listening to the conference but also actively participating!

Alex. Durand-Salmon, Co-author of the blog will share his experience regarding Performance dedicated to Service Providers in the conference “Case study: A real life example of using metrics to  assess the performance of a service provider”.

Also Christophe De Vleeshouwer, Manager Medical Operations at CORDIS (Belgium) who already shared with us his experience regarding clinical trial performance (will held the conference “Critical guidance on the choice of metrics: how to best use them in the frame of pre- and post-market studies and registries”.
If you are interested in listening to the 2-day conference, feel free to visit www.informa-ls.com/metrics and get registered.

Should you not be able to go this event, please let us know your particular points of interest, and feedback you would like to have from this conference !
Shortly after the event we will give you an update !

Thanks for your participation !

Datatrak is highlighting ease of access to site performance metrics as a key differentiator as it launches the latest version of its platform eClinical product suite.

The latest version of eClinical suite is tracking metrics on investigative site performance in clinical trials. Read more

LSIT (Life Sciences Information Technology)is a non-profit organization bringing together several industries to build the first Good Informatics Practices (GIP) guidance document to assist IT in 5 areas: compliance, standards, best practices, risk mitigation and return of investment. GIP is the guidance for improving quality and trust of IT within life sciences and healthcare.

GIP guidance document compiles standards in one reference guide for an IT system of a life science or healthcare environment.

All functions within a life science organization require significant use of multiple IT platforms. Their intellectual property, knowledge management and data are on IT systems that must be trusted and secure.

The integration of IT into Life Science and Healthcare has a “real potential for reducing both the time and cost of bringing new medical products from discovery to the patient. The one main inhibiting factor is “trust”. Trusting that these very complexes IT tools, computational processes, and resulting data are, in fact, accurate and scientifically valid, is critical for all stakeholders and gatekeepers alike”.

More information is available on http://www.lsit.org/

US-Based Phase Forward, specialized in data management solutions for clinical trials and drug safety pays US$40 millions for Clarix LLC, a provider of fully Web-integrated interactive response technology (IRT). Read more

I’m coming back on initiatives around Performance Metrics in the Clinical research area. Someone forwarded me this interesting link: http://www.eclinicalforum.com/

You can find a very good and complete survey of companies involved in conducting EDC trials to assess the feasibility of establishing standard metrics for the assessment of EDC performance. It is not a new document (June 2004) but it gives very useful and focused approach to benchmarking EDC performance.

Lorena Levi, Trainer at Fundacion Cecilia Grierson in Argentina, is sharing with us her experience in operational and performance management in South / Latin America.

Lorena and myself talked about this in the past week, and I am now sharing her thoughts with you. Read more

Christophe De Vleeschouwer, Manager Medical Operations for Cordis Medical (a Johnson & Johnson company) in Belgium, is exposing his thoughts and needs about measuring performance for large cohort clinical registry. Christophe has met us last week, and Alex took his confessions. Read more

We recently covered the topic about dispersed and disparate data.
Within one company, if you have a horizontal view across all trials, you will notice that data is stored in various formats, including diverse relational databases, text files, XML files, spreadsheets and certainly proprietary storage formats. There is no unique way of collecting, organizing and analyzing data.
The problem is to utilize of this critical data to assess the trial’s or program’s performance. Read more