The increase in decentralized clinical trials (DCT) was born from a need for social distancing during the pandemic, but with simplified patient access, the propensity for greater diversity and an increase in patient recruitment and retention, the trend is here to stay.
Those leading clinical trials want them to be faster, more easily accessible, and a better experience for everyone involved from patients and researchers to doctors and nurses. The pandemic brought with it the realization that traditional clinical trials were placing an unnecessary burden on both patients and their caregivers. With the costs of transportation, lodging and meals and time spent away from family (and out of work), participation in clinical trials was not without sacrifice.
how decentralized clinical trials work
When COVID-19 hit, patient access to clinical trial sites was down by 80 percent. With a significant reduction in trial activities, clinical trial sponsors quickly mobilized. The move unlocked a patient-centric approach to conducting trials, and ushered in a new dawn for the clinical trial landscape.
The focus of decentralized clinical trials is to improve the patient experience by meeting their needs and making the whole process more convenient. Through a combination of virtual and physical monitoring, there is less onus on the patient to travel, because activities are brought to them.
While traditional site visits are unlikely to become obsolete for more complex procedures like screenings and magnetic resonance imaging, sponsors are adopting decentralized components in their masses — from remote consent, data verification and patient monitoring to videoconference assessments, drug administration and at-home phlebotomy.
technology is key to successful decentralization
The evolution of technology and healthcare services like remote patient monitoring, electronic consent, telehealth and electronic clinical-outcome assessments (eCOAs), has allowed more procedures to take place away from traditional trial sites. These tools are being increasingly validated to establish standards for broader use.
With the right technology you can easily engage patients from home or their preferred location. And telemedicine is going down a storm: so much so that one survey found 98 percent of patients were satisfied with telemedicine; another, that 72 percent of physicians were seeing similar or improved experiences with remote engagement versus in-person visits.
Decentralization broadens patient access and can help sponsors to reach a far more diverse group of candidates: Through telehealth and remote monitoring, patients who would ordinarily live too far from clinical trial sites to participate can be recruited through the easing of geographical and logistical barriers.
According to ex-FDA commissioner Scott Gottlieb, decentralization modernizes clinical trials and advances precision medicine, patient protections and more efficient product development.
But DCT is not without its challenges.
the challenges of DCT
Whether fully decentralized or hybrid, there are certain challenges that site sponsors must navigate when moving away from a traditional onsite approach.
quality of data
Crucial to any clinical trial is the quality and accuracy of its data. Preserving data quality is often cited as an area of concern amid the push for decentralization. Technical and clinical validation is necessary for data collected through wearables, apps and electronic patient-reported-outcome (ePRO) tools, to ensure sensors generate both reproducible signals and signals that are relevant to key outcomes.
patient comfort
Not every patient will be comfortable with technology — or have adequate access to it. Clinical trials are new environments for most patients, and decentralized components can make them feel more challenging. There will also be patients who prefer to see physicians in person, rather than via video call. It’s vital that thought is given to mitigating patient concerns in trial design.
technical support
The majority of clinical trials will be hybrid, making virtual engagement critical. But with a balance of remote and onsite components, the technological challenges of working across multiple platforms will call for high-quality logistical and technical support.
global regulations
Decentralized trials offer far greater geographical reach, but trial sponsors face the added complexity of adhering to regulatory guidance that differs (and rapidly changes) from country to country. Global trials must therefore tailor their approach to meet different cross-border data standards, adhere to localization rules and factor trial-design complexities into the planning phase.
internal challenges
When handling change management for DCT, trial sponsors are likely to face any number of internal objections and difficulties. For starters, stakeholders may not understand the urgency for the change. There could also be cost pressures, confusion around an operating model for decentralization and the need for increased capability in everything from digital to vendor management. An expert in performance transformation can be invaluable here.
how randstad life sciences can help
Whether you’re embracing hybrid or decentralized trials, or following a traditional path, Randstad Life Sciences can help staff your clinical trials.
In today’s tight labor market, we connect the right people with the right organizations, helping to drive future life-saving treatments and therapies to keep you competitive.
With decades of experience in life sciences, our network is vast, and our talent pool is even stronger. We’ve meticulously built relationships with experienced clinical and scientific professionals, allowing us to match you with the specialists you need, regardless of your trial set-up.
Whatever your need, Randstad Life Sciences has the agility to adjust to the specific staffing needs of your organization. Find out more about our life sciences solutions.