Navigating Today’s EDC Options Scott Brand PhD. Principal Scientist Global Data and Bioinformatics

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 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

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: