Transcript Navigating Today`s EDC Options

Navigating Today’s EDC
Options
Scott Brand PhD.
Principal Scientist Global Data and Bioinformatics
[email protected]
Purpose of Talk
Many options available for implementing an Electronic Data
Capture (EDC) System
Review the good and bad about these options
At the end I hope to leave you as confused as I am
Disclaimer
I gave this talk four years ago at the Society of Clinical Trials
In four years things have changed dramatically
The last few slides will provide an update that will add even
more confusion
At end we will open up the discussion concerning issues
relevant to OpenClinica
The Distant Past
•
•
•
•
All EDC systems were in house data entry
Only a few products available
You either bought one or built your own
A Clinical Trial Management System was a log book or a
Lotus spreadsheet
The Recent Past
•
•
•
•
•
•
•
Data collection through the internet arrives
Still need to buy the system or build your own
You are responsible for installation
You do the Validation
Provided the host servers
Not all the sites had a PC or broadband access
CTMS now several log books or Excel spreadsheets
Present Day
• Many options available
– Purchase commercial EDC or CTMS system and
install it
– Build your own system which resides at your site
– You use a system that is hosted by a dedicated
EDC company
– You obtain an open source system and install it at
your site – latest addition
• There are no wrong answers it all depends on your company
or agency and finding the most cost-effective and productive
solution
Your Decision Based on the 3 Ws
• Who are you?
• What do you do?
• What resources do you have?
Who are You?
•
Large pharmaceutical company
– Many studies run in-house
– Total control of forms and processes (Allows you to customize the system)
•
Contract Research Organization (CRO)
– Multiple studies out sourced to you
– Respond to how client wants to collect the data (limits customization and you have
many masters to obey)
•
Academic department or Government Agency
– Support as few as 1 or as many as 30 studies in-house
– Each investigator may collect their data differently or there could be standardization
•
Single clinic or clinical researcher
– One or two ongoing studies, usually run a non-customized EDC, cost is a big factor
What do you do?
• Are you running pharmokinetic studies or phase I studies?
– Few sites, small amount of data, data by event
• Are you carrying out phase II and phase III studies?
– Many sites, large number of patients and huge
amounts of data, complex study designs
• Are you an academic site carrying out clinical research
– Few sites, small amount of data
What Resources do you have
• Depending on system used varying levels of
support required
– IT personnel for supporting the network
– IT & QA support for installation, validation, testing
– Documentation
– Disaster recovery
• Back up data
• Restore data
• Redundant systems (fail over virtual servers)
– People to create the applications
– Staff to apply updates to system and possibly re-validate
What are the Choices
Hosted System
Build it Yourself
Open Source
Buy it
Hosted System
• Hosted system – You use it another company hosts it
– Access it remotely from hosting company’s installation
– No annoying auditors asking you for validation documentation
– No huge initial cost
– You need people to create the applications
– You need to modify documentation (still need to write or revise SOPs)
– Training
Hosted sounds great, I have now seen the light!!!
But you need further self analysis
Disadvantage of hosted system
• Usually pay a monthly fee for each study on a hosted system
• If study lasts longer than estimated you still need to pay the
monthly cost. (Remember that study that they told you
would take 6 months to recruit all participants, and it took 2
years.)
• Limited access to back end database – If you have a
randomization system or CTMS and you want a direct real
time link, this can present a problem.
Build a System
You are in Control
• You can modify the system or link the system to other systems
• You have access to the source code
• You can integrate other systems to your EDC (CTMS, Randomization,
Screening)
• You have Control over cost – No monthly hosting fee!!
• No annual licensing fee
• Now you wonder why was I ever thinking of a hosted system No Control !!!
But you have to ask, “Do I want control?”
Total Control Means Total
Responsibility
• If regulations change you have to modify the system to
meet new regulations or expectations
• Need QA staff familiar with validation
• You have to create and maintain all design documentation
• Need staff that can maintain the code and create new code
• Need all the hardware to support it
• Building a system takes time and it is expensive
• Your hero developer leaves – who will support it?
Buy a System
• You own it and vendor provides support
• Access to backend data base - its installed at your site
• Vendor can supply everything for a price
–
–
–
–
–
Validation scripts
Training
Updates
Help desk
Consulting
• Cost effective if you run a large number of studies
• Long term marriage between user and vendor
That is some marriage your in!
• You have to host it – personnel, hardware, validation,
etc…
• You spent so much money on system, training, validation,
consulting, writing SOPs you can’t change systems
• Many times I can’t apply the updates or new versions
and I need to bring in the consultant (They like to stay at
nice hotels).
• Vendor bought by another company and no longer taking
your EDC product seriously
Open Source
• Open source gives you the system (just download it) FREE!
• Open source isn’t entirely free (in regards to add-ons and labor)
– Installation, hardware, validation, documentation, training
• More cost effective then buying a system
– More you do yourself in regards to setup and validation the cheaper it is.
• Gaining an audience (CROs, Clinical Departments, Government,
Eastern Europe, Africa, Asia)
• User group can submit new code (new functionality) for approval to
be added to system
• Access to source code – You can modify your own system
But should you?
• You change the source code updates may not work
Open source II
• The first year you will save about 50% over buying a
system
• Following year you will save 60% to 70% over buying a,
variation depends on how much you do yourself
• You may need to fill in the gaps that open source does
not supply
– Documentation (detailed user’s or administrator’s guide)
– Certain features are missing that you would expect in a
commercial product
• You can check it (EDC) out and see if you like it before
you invest a time and effort
Message
• All these EDC systems are just tools
• They won’t make up for a badly managed study
• A group with good practices, IT staff and
procedures will get the job done with a basic
system
• Investing in training and recruiting good people is
definitely more productive than in chasing latest
technology
That’s Where Talk Ended
Four Years ago
EDC has Changed – not the Static
Model Anymore
Static Model vs Anywhere Any Time
• Static - Subject comes in, collect data, then
enter it in EDC
– Set time
– Set place
• AWAT - Subject has ability to actively
participate in data collection using mobile
and/or their own devices
EDC is not an Isolated System
• Integrates with many different systems and
applications
• No longer a stand alone system
Integration
What is EDC?
Change will not stop
• New clinical trial designs
• New technology
– Lab on a chip
– Direct integration with EHR
• New uses
– 24/7 data collection over smart phone(monitoring
activity)
– Subject entering their own data in EDC
• EDC companies will have to respond faster
Contact Information
Scott Brand PhD.
Principal Scientist Global Data and BioInformatics
QPS LLC
Newark, Delaware
Phone: 302 776-3468
WWW.QPS.COM