Convenience, digitization, and greater application are three key benefits that decentralization provides clinical trials and the health industry as a whole. The pandemic demands more modern, digital healthcare solutions and, considering the financial and travel restrictions brought about by COVID, it’s crucial for sites to refine their setups and more seamless ways made available to encourage trial participation.
Decentralized trials are expected to increase by nearly 30% in 2022, with web-based questionnaires and eConsent among the elements to grow considerably, as well as enhanced clinical trial protocols. Additionally, decentralized trials provide more seamless ways for researchers and doctors to do their jobs while enhancing patient experiences. Why are these digital clinical trial alternatives on the rise, and what do they provide that their traditional counterparts do not?
Decentralized Clinical Trials Facilitate More Innovation
Decentralized clinical studies are becoming more commonplace as clinical research organizations (CROs) find new ways to connect with patients from various backgrounds, made harder by the fact that turnover rates high within these organizations are high. Patient dropout continues to be a pertinent area of concern that hampers clinical trials, with travel and a reliance on outdated technologies cited as reasons for low participation rates.
Because of the limitations created by the pandemic, more innovative digital platforms are vital to optimize the collection and distribution of clinical data. Decentralized clinical trials are patient-centered alternatives to traditional clinical trials, becoming strategic priorities for providers as they conduct trials remotely or through local healthcare providers to boost patient experiences. Initially looked on as luxury pilot projects, decentralized virtual clinical trials have become more commonplace since Pfizer first introduced them in 2011.
Decentralized clinical trials utilize advanced technology, with more horizontal and vertical integrations initiated by technology providers, creating more end-to-end measures to deliver these trials.
What are the Benefits of Decentralized Trials?
Decentralized clinical trials address unmet patient needs and eradicate concerns that, with traditional clinical trial models, made them hesitant to participate.
As mentioned above, dropout rates with clinical trials are typically high because of the various restrictions preventing people from participating, particularly travel restrictions. Research shows that around 70% of potential clinical trial participants in the United States live more than two hours from the trial site. Some trials will offer stipends to pay off transportation costs, including reimbursement for gas, public transportation costs, mileage, and air travel. While some clinical trials will cover trial costs, not every clinical trial sponsor offers this sort of coverage. To avoid this altogether, decentralized virtual clinical trials are increasingly being integrated to counteract the adverse travel elements actuated by COVID-19. With these virtual trials, check-ins are done via video conferencing or mobile apps. Additionally, decentralized trials ensure patients get home care services without having to leave home at any point. Many decentralized trials combine remote and in-person activities to ease trial participation for patients, regardless of location.
For sponsors, decentralized virtual clinical trials are helpful because they accelerate clinical development, affording them more representative access to patients. Additionally, decentralized trials create strong evidence packages than their traditional counterparts.
Why Decentralized Trials are Here to Stay
Decentralized trials have created operational shifts and improved efficiencies after COVID-19 shifted the balance of tradeoffs for the industry. Considering the disruptions caused by the pandemic, clinical research organizations and trials must prepare themselves to take more risks and modernize their strategies.
Because the benefits outweigh the challenges, decentralized trials are set to become commonplace long after the pandemic concludes. Regulatory advances are expected in a post-pandemic society to further the adoption of decentralized trial models, with agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency clarifying their guidance regarding decentralized modalities, including cross-state telemedicine. Thanks to a new legislative direction to improve decentralized trial usage, a smoother landscape to administer these trials is expected going forward.
Technology supporting decentralized clinical trials will keep advancing thanks, in part, to high venture capital investments. The technology, in conjunction with patients’ increased usage of digital health technology and increased exposure to virtual patient care, makes it unlikely for trials already taking these measures to revert to traditional methods, slashing costs and expanding their patient base as a result.
More Work Needs To Be Done
That said, there are still hurdles that must be overcome for decentralized virtual clinical trials to become universally adopted in a post-pandemic world. Stakeholders have to dedicate resources and time before the benefits of decentralized trials can fully be realized. Additionally, sponsors must understand how to flexibly implement these trials and root their approaches in a deep understanding of unique patient experiences, supporting patients and sites as they maneuver through their learning journeys.
Decentralized options should also be considered early enough in the clinical trial development process, providing sufficient research time, plus endpoint validation. Leaving decentralization as an operational afterthought adds great complexity to an already layered process.
More robust solutions for sponsors, patients, and physicians alike will make decentralized clinical trials successful and accessible in a world demanding increased digitization and transparency, enhancing patient experiences and making the trial process more rewarding.
