COVID-19 and the Changing Landscape of Clinical Trials

It is not an exaggeration to say the pandemic has impacted operations in nearly every sector and industry. For many, it has meant learning to support a remote workforce or offering services and products from behind a screen. For those of us in life sciences, it has increased the prevalence of decentralized clinical trials.

Remote and mobile technologies have made it possible to continue clinical research and prevent the interruption or cancellation of drug development programs despite the emergence of social distancing and travel restrictions. An Oracle study found 76% of survey respondents have recently accelerated their adoption of decentralized clinical trial methods.¹

Now that we have been forced to make room for new digital processes, there should be no turning back. The industry’s flexibility combined with rapid technology advancements have sped up patient enrollment, enabled access to real-time patient data, reduced trial timelines, and most importantly, helped keep patients and employees safe. Decentralized trials are the way of the future—yet it would be ill-advised to think of them as a one-size-fits-all solution.

Where decentralization falls short

While the pandemic increased the industry’s acceptance of decentralized protocols, moving to an entirely virtual model without in-person interaction is unrealistic. According to McKinsey & Company,² completely virtual trials will remain limited. More likely, pharmaceutical companies, contract research organizations (CROs), and other groups will adopt one or two elements of decentralization in trial design.

This sort of hybrid approach allows researchers to take advantage of the benefits of decentralization while ensuring ethical recruitment practices and successful trial outcomes. For example, a trial protocol may require initial in-person site visits prior to patient enrollment and then leverage remote tools to maintain communication and data collection.

Hybrid protocols are highly beneficial for trials involving rare and ultra-rare diseases, which often require patients to receive specialized treatments at designated sites that do not lend themselves to decentralization. Offering routine lab tests and follow-up appointments at local healthcare facilities or through telehealth reduces the burden of participation for both patients and their caregivers, who are also grappling with the medical implications of their diseases and the typical stressors of daily life.

Many patients with rare diseases are also immunocompromised, and the pandemic has only increased their reluctance to rely on mass transit and air travel. However, they are open to alternative arrangements, such as reimbursements for car rentals or mileage and door-to-door ground transportation provided by professional, vaccinated drivers. Some are willing to consider temporary relocation to reduce their time on the road and potential exposure. In one unique case, the most economical solution involved chartering a private plane so a patient with a rare form of cancer could complete her final site visit.

These non-technical solutions share one thing in common: they demonstrate the same creativity and adaptability that has allowed the industry to embrace decentralized trials during the pandemic. Whatever the circumstances may be, clinical researchers must be prepared to accommodate patient needs and remember that technology can be both a blessing and a curse.

For some patients and caregivers, telehealth appointments ease financial constraints by reducing or eliminating the need to take time off work. However, they may also inadvertently deter patients without reliable access to the internet. Not only does patient diversity promote health equity, but it also allows researchers to identify the effects of treatment across demographics and increases the likelihood of regulatory approval from groups like the United States Food and Drug Administration (FDA). Whenever we integrate digital tools into clinical trials, we must remain cognizant of their disadvantages, including their potential impact on historically underserved populations.

A path forward for patient centricity

According to research from Clinical Leader, 85% of clinical trials do not enroll enough patients, while up to 30% of patients drop out during the course of a clinical trial.³ When the burden of participation seems too great to bear, recruitment and retention rates suffer, increasing trial costs and delaying commercialization.

On the other hand, investing in patient support helps trial sponsors and CROs anticipate and overcome the medical, emotional, financial, and technological obstacles that could make it difficult for patients to participate in their studies.When trial participation calls for it, patient coordinators can work one-on-one with patients and their caregivers to arrange travel and accommodations, facilitate reimbursements and stipends, and more. As patient coordinators earn the trust of patients and caregivers, they build relationships that increase the likelihood that a patient will continue participating through the duration of a trial.

Ultimately, the recent uptick in decentralized trials simply illustrates “patient centricity”—a flexible approach born out of necessity amidst unique circumstances. The future of clinical trials lies not just in technology adoption and remote patient engagement but in our collective ability and willingness to put patient needs at the center of trial design.Patient support services are a natural extension of this concept, offering personalized, empathetic solutions that encourage trial participation and improve trial performance.

Scott Gray is the co-founder and CEO of Clincierge

References

1. Oracle. Survey: COVID-19 the Tipping Point for Decentralized Clinical Trials. November 18, 2020. Read at: Survey: COVID-19 the Tipping Point for Decentralized Clinical Trials (oracle.com)
2. McKinsey & Company. No place like home? Stepping up the decentralization of clinical trials. June 10, 2021, Read at: Stepping up the decentralization of clinical trials | McKinsey
3. Clinical Leader. Considerations for Improving Patient Recruitment into Clinical Trials. Read at: Considerations For Improving Patient Recruitment into Clinical Trials (clinicalleader.com)