Mark Glover, Australia and New Zealand country manager of health technology company Medidata, says enhancing the design and conduct of clinical trials means putting patients at the centre of decision-making.
Clinical trials play an essential role in the development of new medicines. This requires a significant investment of time and money by researchers and sponsor companies. Patient retention is one of the most challenging parts of a trial, with drop out rates often as high as 30 per cent. This is due in part to how cumbersome trials can be for patients, and that burden will ultimately be costly for researchers.
Patients should have access to a trial best suited to their disease and designed with their needs in mind. The goal when designing a clinical trial should be a frictionless experience that doesn’t stop a patient from living their life.
Developing a lean study design that minimises the patient burden can lead to a more positive patient experience, and will ultimately drive operational efficiencies with improved patient retention.
Patient retention is key
Designing a clinical trial with a patient-centric approach can be the difference in achieving target patient enrolment and optimising retention rates. Depleted enrolment and increased withdrawal rates mean trials have a much higher probability of failing. Poor patient retention can lengthen trial timelines, increase costs, introduce higher risk to data interpretation, or even derail trial completion and product approval.
With poor retention comes a poor return on investment.
To ensure stronger outcomes, putting patients at the heart of the design before the trial begins is imperative. When the right considerations and investment into designing patient-centric clinical trials are made, and include virtualisation technologies, patient retention can be dramatically improved.
Much of this patient-centric evolution can be attributed to technological advancements that shift the clinical trial experience outside of traditional investigation sites and into the real world, where patients actually live. Patient-centric trial design that leverages technology means better opportunities for two-way communication with patients to engage with their own data and to get feedback on their contribution to their trial and their own health.
The evolution of the virtual trial
A patient-centric trial, in a real and tangible way, is one that is a virtual trial, which we define as any trial with data activity out of a site. Whether it’s an electronic Patient Reported Outcomes (ePRO) app, or an eConsent form a patient can review and sign at home, virtual trials bring the trial experience to where it’s most convenient and comfortable to patients. Perhaps more importantly, virtual trials give patients more opportunities to engage with their own health data and with their healthcare team.
Virtual trials are not a new concept. ePRO has been around for nearly 20 years. But we’re moving in a direction where 20 per cent of studies could soon be largely virtual and where 80 per cent will have at least one virtual component in the protocol.
Technology should be available for every stage of the patient journey, from education and consent, to data capture and analysis.
Data collection from patients represents one of the biggest pain points for clinical trials, as traditional methods are complex and demanding for patients, potentially resulting in poor data for researchers. The importance of quality data is imperative for research.
Medidata is disrupting and enhancing clinical trials with artificial intelligence and pioneering analytics that uncover actionable insights and drive faster, more effective decision-making for researchers.
If ePro is the old guard of virtual trials, sensors and wearable tech are the new kids for clinical research. One of the ways in which Medidata is enabling better and easier data collection is through the help of smartphones and wearable devices. Australians are early adopters of new mobile technologies, with nine in every 10 adults in the country owning a smartphone. Furthermore, Australians are eagerly adopting wearable technology as it continues to evolve in our market, with wearable (smartwatch/fitness band) ownership reaching 29 per cent in 2017.
Smartphones and wearables are more than just pocket-sized computers. They contain onboard biometric and global positioning systems that make them uniquely powerful passive data collection devices.
The use of mobile technology is not just beneficial to patients, but also to sponsoring companies and investigators. Ultimately, when implemented correctly, the use of virtualisation technology could increase access to clinical trials, increase patient engagement, reduce patient burden, improve compliance and reduce costs.
Closing the digital divide
In Australia, with the roll-out of the nbn network and the approach of 5G in 2019, more Australians are getting access to high-speed internet, which enables patients to participate in trials remotely. This gives sponsoring companies access to a breadth of patient profiles which they may not have had previously. Connectivity ensures that a patient-centric approach can be achieved by sponsoring organisations.
When patients can easily enter required trial data remotely (actively or passively), it eliminates the need for complex processes, helping to keep the engagement simple and the likelihood of patients remaining in the trial high. Patient retention is a critically important factor in the success of trials and in the ability to accelerate new possibilities in medicine.
Patients strongly value effective, two-way communication with their doctors and nurses and trials need to be designed with the right tools to accomplish this. Medidata strives to accelerate hope and advance life sciences through technology. By considering the patient first in the development of the study, sponsoring organisations can improve the patient experience and, in turn, the success of the trial itself. By embracing new technologies and driving patient-centric trial design right from the beginning, we can vastly improve the trial experience and outcomes for patients, while realising greater patient retention and return on investment.
This ultimately leads to patients getting access to new medicines faster.