Decentralized Clinical Trials: Bringing Care Directly to Patients

Oncology Nursing News, April 2022, Volume 16, Issue 2

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Evolving technology and adaptability allow for a more patient-centric approach to clinical trials; however, there are some limitations.

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

“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.”

Abraham noted that patient satisfaction has increased since adopting DCT methods. “It helps to reduce patients’ pandemic-re- lated stress and any transportation issues they may encounter in commuting to the clinical trial site,” she said.

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