Decentralized Clinical Trials: Bringing Care Directly to Patients

Clinical trials have long faced a multitude of challenges, including patient enrollment and retention. Now decentralized clinical trials (DCTs) that allow patients to participate remotely intend to simplify the process.

DCTs are defined as studies “executed through telemedicine and mobile/local health care providers, using processes and technologies differing from the traditional clinical trial model.”¹ These trials go beyond traditional brick-and-mortar research facilities to allow many clinical trial activities to be conducted virtually rather than in person.

By utilizing technology, such as telemedicine, to deliver consent and education, remote monitoring, direct-to-patient distribution of investigational medicines, and use of local labs and image centers, DCTs offer a more patient-centric approach to clinical trials.

Although there has long been an interest in decentralizing clinical trials, the COVID-19 pandemic significantly sped up the adoption of DCT methods. Suddenly, patients were unable to physically visit clinical trial sites, and the Lancet reports an estimated 80% of non–COVID-19 trials were either halted or interrupted by the pandemic.²

Although DCTs are proving to be promising, Abraham says they present some challenges. “During the pandemic, exceptions were made to allow for virtual assessments in our breast oncology research group, and we have the ability to allow more virtual assessment for patients with all cancer types,” she said. “However, insurance requirements have recently become stricter and don’t always allow coverage for out-of-state virtual assessments. Unfortunately, this may hinder the progress of decentralizing clinical trials in the future.

“We’ve worked to decentralize many of our trials to help fit the needs of our patients during the pandemic,” Elizabeth Abraham, RN, BSN, a senior clinical research nurse in breast oncology at Massachusetts General Hospital in Boston, said in an interview with Oncology Nursing News®. “Our team modified the process to allow for virtual prescreening for trials, virtual consents, telephone adverse event assessments, and virtual visits.”

Another challenge is ensuring study participants receive immediate care in the event they become ill. “If a patient is experiencing any adverse events, they must come into [the] clinic or be seen locally for [an] in-person evaluation,” Abraham said. “If they are seen locally, our clinical research team will obtain records for review to provide recommendations and guidance.”

Although DCTs are proving to be promising, Abraham says they present some challenges. “During the pandemic, exceptions were made to allow for virtual assess- ments in our breast oncology research group, and we have the ability to allow

A Southern California Cancer Center Expands Its Reach

With over 35 locations in Southern California, City of Hope, a cancer research and treatment organization, employs a hybrid approach to decentralizing its clinical trials. Instead of relying on its main campus in Duarte as the primary clinical trial site, it uses its satellite locations in Lancaster, South Pasadena, Upland, and Corona, to recruit patients and stream data.

Paul Raborar, RN, a clinical research nurse at City of Hope, oversees clinical trials at these satellite sites and believes offering DCTs in the communities where many of their patients live will enable faster and more diverse enrollment in their clinical trials.

As an example, Raborar cited a recent clinical trial for prostate cancer (NCT04734730), a type of cancer that disproportionately affects Black men, who are more likely to receive a diagnosis at an advanced stage. “The community sites have provided 31% of the study population to date,” he said. “There has been an uptick in enrollment. Opening up in the community created new patient inflow. Some studies incurred their first patients from the DCT.”

Through City of Hope’s Division of Health Equities, the staff provides prostate cancer education and free screenings to Black and Latino men in the greater Los Angeles area. In addition to conducting outreach, they also discuss City of Hope’s current clinical trials. “We cast a wide net, and through our community outreach events, we [are able to] build trust with patients,” Raborar said. “We also educate our community practice site doctors on our clinical trials so they can refer a wide range of patients to our trials.”

Although DCTs are gaining in popularity, Raborar says they are not without their own challenges. “The 3 biggest challenges are securing the right infrastructure and technology, ensuring sufficient study target population and diversity at sites, and coordinating financial and insurance concerns in conjunction with study requirements,” Raborar said. “Managing all 3 challenges is essential for patient safety, the protection of study participants’ rights, proper performance of study requirements, and minimizing its financial burden.”

For oncology nurses, Raborar noted that DCTs represent an interesting job opportunity for those who want to pursue a career in research. “Depending on each site’s requirements, a clinical research nurse should have good assessment skills, exceptional communication and teaching [abilities], and 2 years’ experience in oncology or research nursing, but they do not need to have a background in both oncology and research,” he said.

Working in DCTs

To work in DCTs, Abraham said nurses should also have experience working with diverse patient populations while maintaining cultural competency.

“This requires nurses to work well with non-English speaking patients by using interpreter services by phone,” she said.

In return, Abraham believes DCTs present oncology nurses with the opportunity to move beyond the bedside and work on research that has the potential to make a significant impact on patient care. In addition to giving nurses the opportunity to improve the telehealth experience for patients and health care workers alike, it allows the nurses themselves more variety in their work.

“Decentralizing clinical trials allows nurses to have more diverse opportunities,” she said.

References

1. Supporting decentralized trial approaches. Clinical Trials Transformation Initiative. Accessed March 15, 2022. https://bit.ly/3CN7DBL
2. van Dorn A. COVID-19 and readjusting clinical trials. Lancet.2020;396(10250):523-524. doi:10.1016/S0140-6736(20)31787-6