2013 Trend: Turning Data into Medical Knowledge
Once computers started to be used for clinical data management, it was only a matter of time before their use moved from the back office to the site of data entry at the physician’s office. We make a distinction between clinical data management systems (CDMS) used by data managers and electronic data capture (EDC) systems used by sites, but they share many similarities. So many, in fact, that many traditional CDMS functions for data cleaning are now integrated into EDC systems. There are nuances, but EDC is really the extension of CDMS outside of data management.
The EDC system, like CDMS, consists of a database, a form designer and some way to write edit checks. Specialization for clinical studies is remarkably absent—to the point where you can bend the average EDC system to collect data on almost anything. Rename “subject” to “policy” and an EDC system will give you a workable structure for collecting data for insurance policies.
Every subject ever enrolled in a clinical trial has had their height and weight recorded and yet the major EDC systems do not have specialized data entry controls for these, treating them instead like any other numeric fields. There are human limits to heart rate and blood pressure but our systems don’t know them unless they’re told in an edit check.
In the age of iPhone’s Siri, it suddenly seems strange that we can’t ask our EDC systems to list “Overweight adult males with a history of hypertension.” Such a query instead has us running to our reporting tools to find the fields for sex, birth date, height, weight, systolic and diastolic blood pressure.
We have data; we lack knowledge. 2013 might be the year we start to think about ways to bring that knowledge into our eClinical systems.
More on Ian Sparks
Comments in this post
Leave a reply
- mHealth in Clinical Trials: Instrumenting the Patient with Sensors, Wearables and Apps
- Paper Patient-Reported Outcomes: Golden No More
- Revolutionionizing the Way Physicians Connect Patients to Life-Changing Treatments
- Addressing the Patient Recruitment Challenge in a Disruptive Way
- Risk-Based Monitoring Updates: TransCelerate, the Value of SDV, Global Monitoring Trends and More
How are clinical studies conduc ...mHealth in Clinical Trials: Instrum ...
By providing study volunteers w ...How Do Medical Device Companies Vie ...
When it comes to risk-based mon ...Revolutionionizing the Way Physicia ...
ePatientFinder makes it possible ...Addressing the Patient Recruitment ...
http://youtu.be/Y_WQ2mGxOqg ePat ...
How Can We Accelerate Innovation with Standardization? Thoughts from the CDISC European Interchange
Kudos! What a neat way of thkiinng about it.
Ni Hao from Shanghai! 上海的你好
Great article. Exciting times ahead. I believe that China will award us the rare opportunity of applying our platform as...
Data Management, Safety Systems and How Technology Can Improve Clinical Development Processes
It is a nice blog. It contain good information on clinical data management
Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
Agreed - a new term would have been preferable, but we of course have the benefit of hindsight. We’re...
Clinical Data Analytics
Clinical Study Design
Clinical Trial Budgeting
Clinical Trial Management
Clinical Trial Phases
Cloud Computing, SaaS and PaaS
ePRO and mHealth
FDA and Regulatory Affairs
Innovation and Entrepreneurship
Interoperability and eClinical
Randomization and Clinical Trial Supply
Site Engagement and Monitoring
Technology and Agile Development