Trial and error: how digitalisation is a game-changer for clinical research

Among the myriad transformations forced by COVID-19, decentralised clinical trials may have changed approaches to clinical research for good, bringing a patient-centric approach, reduced costs and faster results. None of this would be possible without digitalisation.

While decentralised clinical trials (DCTs), or virtual trials, have been conducted for more than a decade, the pandemic was the catalyst for industry-wide uptake and many sponsors and clinical research organisations (CROs) have chosen to continue with – or adopt – the DCT model.

DCTs do bring challenges:  investment is required in technology, and ethics and security protocols need to keep pace. In some cases, mindset is an obstacle.

Technology continues to evolve, and patients and clinicians are increasingly comfortable adopting digital technologies in healthcare and clinical trials. It may be a few more years before DCTs are the norm, but, as sponsors, CROs, site investigators and patients are increasingly exposed to them, the more at ease they will be.

There are two main benefits of a DCT:

• The connectivity and networking make the process more straightforward for patients. Technology platforms connect patients, clinicians, site investigators, sponsors, regulators and other stakeholders in the clinical trial; and
• Data-sharing in real time makes processes more efficient and cost-effective, even expanding the scope of trials to more patients, and speeding up research.

DCTs demand a willingness to embrace new procedures, approaches and innovations and they require investment, although given the millions of dollars companies lose each day in trials not completed on time, the savings can be significant.

Tufts Center for the Study of Drug Development says DCTs offer the potential for 14 times the return on investment for phase-3 trials through faster trial timelines[i].

E-consent is easier

At enrolment, e-consent makes it easier than traditional paper methods for patients to get information about the trial. Some studies have found that well-designed e-consent gives participants a better understanding of the information[ii].

Engagement applications keep the patient connected with the study team in real time and provide regular reminders about their responsibilities, such as taking medication or completing a questionnaire.

Data collection is drawn from different sources, including wearables, devices, electronic health records and other e-source platforms, allowing study staff to capture clinical trial data in real time. Telemedicine connects the patient with care providers, including clinicians.

Using these technologies does require sponsors and CROs to redesign their clinical trial methodologies and processes. Change management is, therefore, an important implied aspect of DCTs.

Home comforts

DCTs are conducted partially or fully at the patient’s home rather than at a clinical site.

The study physicians (investigators) can be supported by a centralised study team to manage the interactions with different sites, patients and regulatory documentation. Study staff, such as nurses and laboratory technicians, can conduct in-home visits or visits to nearby care centres in collaboration with the investigator to make the process seamless and improve the experience for patients.

Digital enablement, data security and data authenticity can be resolved with the right technology and processes. The sponsor is responsible for ensuring the system anonymises the data while the institutional review boards (IRBs) need to ensure these ethical standards are properly handled.

Protocols must be designed to consider a trial’s digital components. This will influence trial applications with ethics committees or IRBs as well as regulatory submission activities.

Keeping patients in the loop

Digitalisation is entrenched across the pharmaceutical industry, playing an important role in R&D innovation. In clinical studies, its benefits are being felt by sponsors, sites and, crucially, by patients.

There is no doubt that digitalisation in the clinical space is revolutionary, tied as it is to patient-centricity and, tied to that, able to tackle some of the biggest challenges for any clinical trial. Patient recruitment and retention for clinical trials have long been problems for sponsors. Patients won’t enroll or they drop out because they have not felt connected and because the demand on their time is overwhelming.

There will likely always be a need for patients to visit sites and clinics for some activities, but DCTs and digitalisation will transform clinical research and deliver a better patient experience – and one that will ultimately also benefit sites, CROs and sponsors.

About the Author

Rajesh Jain, MBBS, is Head of Operations India and Global Lead Clinical Development Solutions at PharmaLex. Rajesh has spent many years in the pharmaceutical industry, working in global clinical trial management and medical affairs and leading business operations.

[i] Analysis: DCTs Are Proving Their Benefits, Significantly Cutting Down Trial Costs, Jan 2022, https://www.centerwatch.com/articles/25930-analysis-dcts-are-proving-their-benefits-significantly-cutting-down-trial-costs

[ii] Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review, Chen, C., et al, May 2020, AMIA Jt Summits Transl Sci Proc, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7233043/