The digital transformation of clinical research
Digitalisation has been a hot topic in clinical research for some time now. According to GlobalData, 79% of clinical research professionals have a digital transformation strategy in place or are working towards one. However, digitalisation is not just “doing things digitally”. The adoption of any new technology ways heavy on having the right people and processes in place, especially when these technologies have the potential to impact scientific validity, data integrity, benefit-risk ratio or the safety and well-being of study participants.
For this article, we sat down with Nick van den Bulk, Head of Clinical Operations at CR2O, a full-service CRO specialised in complex early-stage clinical studies, to talk about the company’s experience with digitalising clinical operations. We touch upon the company’s main motivations for digitalisation, the most promising eClinical tools, and key implementation challenges—including how these relate to patient-centric and decentralised clinical research.
Tell us about your background and role at CR2O.
I have a background of 15+ years in managing international clinical trials within all phases of clinical development. This has provided me with experience in a a variety of therapeutic areas including infectious diseases, oncology, auto-immune diseases, and gene-therapy. As Head of Clinical Operations at CR2O, I’m responsible for all operational aspects within the company. This includes departmental oversight on projects and budget management, ensuring team alignment on key tasks, interacting with partners and clients, drafting mutual agreements, and guaranteeing a quality data package.
What are CR2O’s main motivations for digitalisation?
The clinical trial landscape is changing quite rapidly. There has been a big shift towards improving the patient experience and optimising operational efficiency. Digitalisation ultimately allows for a more harmonised collaboration between sponsor, CRO, site, and patient. It enables better oversight and allows you to track data in real-time as it comes into the system.
At CR2O, we are specialised in operating complex early-stage clinical trials. These type of studies require additional governance and oversight as they often entail a complex indication with a rare patient population and a need for collecting real-world safety data. This means you need flexible and pragmatic fit-for-purpose solutions that enable you to gather all necessary data. Real-time oversight can make a big difference here, as it enables you to monitor what’s happening on-site while also allowing for remote patient monitoring in decentralised clinical trial settings.
What digital tools do you think show most promise?
The range of eClinical tools at our disposal has become increasingly advanced over the years. Tools for electronic Patient Reported Outcomes (ePRO) collection have enabled us to digitalise all patient surveys. In practice, this means patients are now provided with an app that they can use on a daily basis. With paper-based patient diaries it was always difficult to evaluate when the entry was made. Using ePRO you know exactly at which moment the data were entered and you can send reminders and notifications to help ensure data are collected within the appropriate time window. This ultimately promotes compliance and can also help boost patient engagement and motivation.
For the sites, a purpose-built eSource tool can give them the opportunity to enter all data in a single source that is directly integrated with the EDC system. This saves a lot of time for site personnel, as data doesn’t have to be entered in the eCRF manually, takes away the risk for possible transcription errors, and reduces overall study cost, as on-site monitoring requirements are reduced.
Next to ePRO and eSource, we are following the growing acceptance of eConsent with great interest. While the regulatory landscape in Europe is still evolving, we strongly believe eConsent could greatly benefit both patient and site. An electronic informed consent form can include various multimedia components and reference materials that can help patients with better understanding clinical trial processes and requirements. It thereby opens up the opportunity to explain informed consent in different ways. One patient might favour video while the other might prefer to read the trial information. The beauty of eConsent is that you can offer these options all at once, allowing the patient to choose their preferred format. This stimulates the trial experience for the participant by increasing patient-centricity.
What do you consider to be key challenges in digitalisation?
The regulatory part can be challenging. For instance, eConsent is still not allowed in all countries across Europe. We would like to see harmonisation as soon as possible so that we can integrate eConsent in our day-to-day operations. Regulatory bodies should really step in here and support the further digitalisation of core study processes.
Another area is change management. Adopting new digital tools often requires a change of mindset for people. Given we operate in a highly regulated industry, people are more hesitant towards changes. It’s therefore important to bring forward that there’s both a need and urgency to move forward with digitalisation objectives.
What’s your take on enabling more patient-centric clinical research?
Patient centricity requires that digitalisation solutions are implemented in such a way that the needs of the user are at the center of the decision-making process. We see a growing body of solutions where participants can collect data using their own devices and where participants can follow their individual progress and results throughout a study. Think for instance of data such as heart rate or blood pressure measured through a smartwatch or medical device. Having this data at hand can be quite empowering for patients. Over the past years we’ve really seen a societal shift towards providing patients with more ownership and control over their health data and we think this change is here to stay.
What are your thoughts on the decentralisation of clinical research?
We see that decentralised and hybrid trial designs have become increasingly common, partly due to COVID19, but ultimately because of convenience—it simply makes it easier to participate in clinical research. Participants are not required to travel back and forth to the clinic as much, which is especially relevant when living in a remote area with no access to a nearby hospital. This ultimately ensures that participation in a clinical trial becomes less of a burden, thereby increasing recruitment potential and compliance. Considering most people own a smartphone nowadays, we believe decentralised trials will really promote clinical trial participation and data contributions on a global scale.
What’s next for clinical trial digitalisation?
Although we experience the added value of digitisation every day, there’s still much ground to be gained. We believe that the digitalisation of clinical trials has only just started and that a lot of innovative solutions will be developed in the near future, making clinical trial conduct more affordable while simultaneously promoting patient-centricity and compliance. At CR2O, we are committed to finding further efficiencies for the benefit of everyone who contributes to the development of new medicines.