Why bother? Trying to do something differently in an academic or NHS setting can sometimes be a frustrating experience.

Using technology in non-commercial clinical trials

SPIRIT Trials Team

Why bother?

Trying to do something differently in an academic

or NHS setting can sometimes be a frustrating

experience.

Limited resources compared to commercial trials…

…but non-commercial trials have to work to the

same regulations.

But necessity can drive innovation…

We’re not claiming we’ve set the world on fire…

…but we’ve tried a few ideas that have challenged the traditional way of running academic trials…

…how many of your trials give patients access to their eCRF data??

About us….SPIRIT Chronic Myeloid Leukaemia (CML) Trials

Map of SPIRIT

trials sites

across the UK

The SPIRIT Team

• Team of only 10 responsible for:• site monitoring• data management• pharmacovigilance• drug supply• regulatory

• Team members have multidisciplinary roles combining some or all of these functions.

• Some team members located remotely to cover geographical spread of trial sites.

• Trial sites do not receive payment for recruiting patients or entering data so need to be motivated in other ways.

• 3 phase 3 CTIMP trials recruiting at ~175 trial sites across the UK.

• Looking at long-term outcomes – 10 year duration studies.

• >2000 patients involved when recruitment complete.

We have a great team…

…but we need to be as efficient as possible to make it work.

So we put all our study documentation on our website so sites can get it for themselves…

We use an eCRF so we don’t have to visit study sites as often to collect data and can resolve data queries remotely

We plan to give our patient’s access to their real-time trial data via the eCRF.

We want to do this to engage patients in the trial and to make the trial process as transparent as possible for the participants.

We also thought it might motivate our trial sites to keep their data entry up-to-date!

But we’ve not quite got there yet as there was a lot to think about…

Patient access to eCRF dataSome considerations:• Security

– ensuring patient can only access their own data– Mechanism for distribution of login/password details– eCRF’s aren’t designed with individual patient access in mind

• Instruction manual– Must be approved by REC– Must be ‘user friendly’ – trial age demographic 18-88 years

• Data– Is data entered on a trial database in an understandable format for the lay person?– Should we provide a summary or report – will that require interpretation (i.e. medical

input?)– What happens if a patient sees test results before their doctor has seen them to discuss

– psychological implications– What if comments made in the eCRF are misinterpreted by the patient – potential to

harm relationship between patient and their care team.

We haven’t resolved all these issues as yet….but we’re working on it.

Central and risk-based monitoring

These are the new buzz words at the moment but we’ve always had to monitor in this way as we don’t have enough people to visit sites frequently.We monitor eligibility and consent centrally as these are key.We aim to visit each site a minimum of once every 2 years.Additional site visits are based on risk.

How we do risk-based monitoring

• We grade sites according to risk based on a range of factors including:– Research experience and staff turn-over– Patient recruitment (more patients = higher risk)– Algorithms looking at data patterns and outliers e.g.

unusually high or low number of AEs reported per patient-month

– Evidence of poor protocol compliance– Incomplete or poor data entry– Sites that report and SAE

How we do risk-based monitoring cont…

• The higher the site’s risk assessment the more frequently a monitor will visit. – A low risk site (e.g. 1 patient recruited, no data problems

identified) will only be visited once ever 2 years.

• We define critical data points crucial the validity and endpoints of the trial.

• At site we SDV all critical data points for all patients.

• We also SDV a sample of all other data points which triggers further checking if a systematic error is uncovered.

Pharmacovigilance

We use an electronic fax system to receive SAE reports:• Ensures our busy CI

can review SAE’s in real time even when he’s on-call or on a ward round.

• Ensures we can comply with SUSAR reporting timeframes.

• Ensures real time continuing risk-benefit evaluation for the trial.

Non-commercial Trials

Getting the job done properly with less resource.