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

Thank you

Questions?

Emma Banksemma.banks@datatrial.com