how do we make the most of technology to enhance the clinical trial process in oncology? emma banks...
TRANSCRIPT
How do we make the most of technology to enhance the clinical trial process in
oncology?Emma Banks
Clinical Trials In OncologyMunich, 2011
Disclaimer
My views and opinions and not necessarily those of Datatrial
To cover……..
Mapping technology onto a complex trial Understanding the impact on roles and the
regulatory landscape Exploring how we can use technology as a true
facilitator to better research and not a barrier Technology does not remove risk; how roles
change for the better when technology is optimally used
Looking to the future – what might we see based on increasingly complex protocols
Setting the Scene The 21st century is a truly digital age
Most of us have smartphones
Over 200 million users of Facebook
Google+ reached 10 million in 2 weeks
This is the age of sharing and transparency
Some history….. In 1993 when President Clinton took office: approximately 500 websites
In 2001 at the end of his tenure: over 36 million websites
Computers have been networked since the 1960s
First email sent in 1971
So, where are we….. Slow technology adopter
Data privacy
Regulations
Site IT infrastructure
Technology changes peoples lives
Where are you?
How many people use any kind of data collection or trial management technology in trials?
How many people think it is all working optimally?
How many people think it makes the overall trial process easier?
How many people have sites who love e.g EDC?
How many people think their jobs have been made easier by technology?
How we like to describe the way technology improves our
lives Easier Quicker Efficient Collaborative Empowering Cleaner data Quicker database
lock
Safer
Happier sites
Happier investigators
Happier sponsors
How we often feel about technology
Overwhelmed Disillusioned Lack of efficiency Not quicker Not easier Too much change…….
Why?
Mapping technology onto a complex trials: specifically Oncology
Too much expectation that the trial will fit the technology
Complex clinical setting and data collection– Personalised approach– Companion diagnostics– Sick patients– Safety oversight– Challenging endpoints– Adaptive approach
Data step inherent in site process
Understanding the impact on roles
Roles have changed– For better and worse?
Do we fully appreciate how? Does everyone really want to use
technology? How do we make this easier? Have people abdicated responsibility
due to technology?
Role change, not abdication
EDC and ePRO alone does not make the data better or the patient safer…….
CTMS does not control the trial alone……
And so on…….
People have to change what they do, not stop doing it!
And the regulatory landscape?
21 CFR Part 11 Guidelines, but limited guidance– Safer to maintain an interim paper step
than embrace eSource Patient safety Use of electronic medical records?
Can we start again please? What would the ideal process for data collection
look like? Where would EHR and eSource fit?
Patient electronic record to EDC/CTMS Patient to EDC Direct entry to EDC with patient
Are hospital IT systems ready for this? NHS in the UK: £11billion project to implement
consistent IT systems……it’s been stopped (incomplete)
Technology as a true facilitator
So what’s next?
Building studies straight from protocol Data standards: front and back? Risk assessment and management Vision Role change management and
encouragement Regulatory changes? Leadership……..
We can’t avoid this – we have to be better at it