The clinical trial industry has access to more advanced technology than ever before, but what impact will these technologies have? Here, the effects of these technological advances and the challenges which will be overcome by them are explored by industry professionals as they express their views regarding the developments.
Dr. Raphaela Schnurbus - Clinical Solutions Director at CRO OPIS
The big challenge at the moment is to manage all the analytical and Artificial Intelligence. We need technologies to support this, to manage all the big data that is coming out of clinical trials.
What is really needed in clinical trials? We know that the process is long and complex... We need a technology that can combine and be one source. So for EDC platforms - electronic data capture - many companies have their own platforms and many service providers offer their own platforms and the aim is to keep it all in one source.
The real challenge here is to combine different technologies from other data sources and stakeholders in the trials... The important point is to have the compatibility so that the systems and the technologies can speak with each other.
We have a lot of help on the market. We all know that trials are succeeding or failing due to recruitment, so we have platforms that help to manage recruitment, to retain patients, to engage patients. We all know that on mobile devices or tablets via apps, we can do patient electronic diaries.
We already speak about electronic informed consent, but this is still a big challenge. The first electronic informed consents were performed, but some of them failed. Why? Because they are ethics were not aligned we were not ready to manage this. So the big challenge here is to not only to have the technologies available and to combine them and have them in one source, but the various stakeholders of the trial need to be prepared.
Dominique Demolle - CEO at patient characterisation technology company Tools4Patient
‘There are a lot of challenges. Of course it appears simple to the user, but behind the scenes it has taken four years of research to produce the first application, using a lot of different types of expertise; mathematicians are working with us, disease specialists working on the most pertinent questions, and working with very high tech statistics.’
‘To add the technology to a clinical trial, you have to come up with something simple because clinical development, clinical protocols, have become tremendously complex, with lots of observations made on the patients. So you cannot complicate the life of the investigator or for the patient further.
One of our critical success factor was to have a technology that would be easier to use for the clinical team. So basically, it is a psychological questionnaire that is administered to a patient just before they receive the first dose of the protocol. After that all the other data that we need to process the mathematical algorithm and predict the placebo response, is collected in all clinical studies, such as your demographic data, disease intensity or medical history for example. So for the study team it is only a questionnaire, but at the end of the day we put the data from that questionnaire with the data that is collected anyway in the study. So the word is ‘simple’!’
Vivienne van de Walle - Director and Research Physician at the independent research Site PT&R
'I've been in the business for over 20 years so we've seen things progress from paper, to electronic EDC and eDiaries and iPads. It has been a challenge when these things are first implemented, but it has definitely now made work easier for us as a site. The data is much more quickly available both to data management and to pharma, ultimately hoping to shorten timelines so we can get the drugs to market faster and available to our patients.'
Dr. MaryAnne Rizk - Global Vice President of Biopharma Partnerships at Clinical Data Company Oracle
'Years ago we were talking about the Cloud and mobile, and that's allowed us to have improved access to clinical trial data and the volume and variety. Now, really the technology that Oracle has anticipated - being a data company - is understanding how we make sense of all this volume and variety.
It's understood there's about eight billion data points per patient in a clinical trial - that's a lot of data. So in order to be able to aggregate all that data, to be able to automate some of the services that were once very much overdone and repeated by Sponsors and CROs, we took it upon ourselves to release a solution called DMW - Data Management Workbench.
I like to use the term the 'ultimate cleaning machine' because it really allows us to help in the clinical research process to automate redundant processes and really create a single unified platform and a single source of truth for data. No longer are you doing 'data transportation' - moving data from one source to another. [You're] able to holistically look at your EMR data, your mHealth data, your IoT, your genomic data, your EDC data in one location. So we're able to help Sponsors in the race to optimize from source to submission readiness.'
Matt Cooper - Business Development and Marketing Director at NIHR Clinical Research Network
'The huge one is the whole digital agenda which is going on at the moment. Particularly around using digital technologies to make it easier for patients to both find out about clinical research and secondly to participate. Along with that goes the piece about linking data records together.
Again, in the NHS we've got a really rich data history with the number of patient records - a single health provider with a single NHS number that links every individual. It's about making the best of those data linkages to pull the data together and make it as easy as possible for the patients to then participate in trials.
Also, trying to offer patients choice; as part of their passage through the NHS, make trials part and parcel of that standard care. So, having digital systems where they can go and find out about clinical trials happening in their particular disease area.
The more the patient becomes empowered, there is the ability for them to say they want their data to be used more regularly and for data sets to be linked together - from their healthcare records and looking at other data sets such as cancer registry data, to make a richer patient. You're having the patient more in control of how they get involved in trials and where and when those trials are taking place.'
Dr. Diana Sims-Silbermann - Senior Trial Manager of Early Development and Clinical Pharmacology at Janssen
'The digitization of acquiring data; the movement of having the patient get a smartphone and be able to enter his data daily instead of having to come to the site to take a questionnaire or to report his adverse events. This is a tremendous help because these protocols often require patients who are ill to come more often than might be necessary to the site for check-ups that could be done at home.
Even tracking their blood sugar or blood pressure; if it was possible that they didn't have to come to the site to get this done, it would be a great improvement.'