How do we make the most of technology to enhance the clinical trial process in oncology? Emma Banks Clinical Trials In Oncology Munich, 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 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……its been stopped (incomplete)

Technology as a true facilitator Holistic data collection and reporting No SDV / minimal SDV Focused data cleaning Easy data reporting Clinical trial technology For example: ePRO For example: EDC Patient / Clinician EHRProtocol

So whats 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 cant avoid this – we have to be better at it

Thank you Questions? Emma Banks