Decentralized Clinical Trial Models: Are They Here to Stay?

Nadina Jose, MD headshot

Nadina Jose, MD, Assistant Professor, School of Health Professions, Rutgers, The State University of New Jersey

Decentralized clinical trial (DCT) elements enabled clinical research to continue during the pandemic, when physical attendance at healthcare facilities was often impossible. These relied on use of various innovative processes, systems, tools, and technologies by study participants and clinical research professionals alike – either onsite or offsite at centers such as pharmacies or even at the patient’s home.

“Aspects of DCTs have technically existed for as long as 15 years, but this buzzword has gained in popularity since the start of the COVID-19 pandemic,” notes Nadina Jose, MD, Assistant Professor in the School of Health Professions at Rutgers, The State University of New Jersey. “We’re hearing that DCTs are now the norm, yet questions remain about their sustainability and future applications.”

Jose identifies current DCT trends as including:

  • Increasing adoption of DCT technologies, with 28% of industry leaders indicating in a survey that they used DCT technologies pre-COVID, compared to 87% currently using DCTs or planning to do so within two years.
  • Greater use of telemedicine at clinical trial sites, with adoption increasing from 12% pre-COVID to 80% during the pandemic, and an expectation that this figure will be around 73% post-pandemic, according to another poll.
  • Home visits being popular, with 79% of patients indicating in a survey that they would find home visits in trials somewhat/very appealing, and 58% being more likely to participate in a study offering telehealth services.

“These survey results suggest a continuing role for DCT models post-pandemic,” says Jose. “Yet, questions remain about their impact on investigator oversight of patient safety, ethical aspects, protocol design, budgets, and data quality and integrity.” Experience to date within academic research centers and academic medical centers suggest that DCTs can have both pros and cons:

Pros of DCTs include the fact that such trials:

  • Reduce barriers to enrollment and participation
  • Support improved diversity and inclusion
  • Improve patient engagement and retention
  • Boost operational efficiency
  • Strengthen study resilience with increased risk mitigation

Cons of DCTs include challenges related to:

  • Monitoring participant safety
  • Managing investigator delegation and oversight
  • Complying with state laws related to elements such as drug dispensing and healthcare provider licensing
  • Ensuring the security of participant data, data flow, and data storage
  • Implementing new technologies and processes

“Taking advantage of the pros of DCTs while mitigating any negative impacts from the cons will be central to future success, along with logical mapping of the decision processes involved in study design,” concludes Jose. “Holistic, integrated platforms are needed, with a hybrid model likely to be most popular, and minimal use of traditional, fully onsite models.”

DCT Models: Are They Here to Stay?

Join Dr. Jose at ACRP 2023 [April 28 – May 1; Dallas, TX], where she will provide guidelines, tools, and suggested workflow templates for clinical research professionals faced with adopting the use of decentralized models. View complete schedule. 

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“Easing the implementation of new approaches in academic settings will help advance DCTs,” concludes Jose, who proposes four initial steps to achieve this. First, she suggests making incremental changes, rather than becoming overwhelmed with entirely new technologies and processes at once. Second, adding support for study teams, who will need additional time and training to evaluate new approaches and processes that add value. Third, listening to potential study participants to understand barriers and preferences.

Finally, Jose highlights the importance of creating alternative options, for example, exploring specific visits in the study schedule that could be performed away from a traditional research site, and deploying patient-friendly technologies such as wearables to collect outcomes data. These will support a critical benefit of DCTs: the ability to minimize the burden of participation and support enrollment of underserved populations.

Author: Jill Dawson