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A Success Story of a Site-Centric Approach to Hybrid DCTs – ACRP

Many in the clinical trials ecosystem would like to see wider adoption of decentralized clinical trial (DCT) elements. “Yet, despite recent draft guidance from the U.S. Food and Drug Administration,¹ as an industry we haven’t made huge strides in adopting this model for interventional studies,” notes Noelle Gaskill, Head of Clinical Research Collaborations at Mirati Therapeutics, Inc. “Sponsors still lack reassurance that all regulatory requirements will be met, and technology adoption is a true barrier for sites. In addition, there has been a lack of practical, real-life experiences to learn from.”

“Working closely with sites, key opinion leaders, and regulators, we have agreed on a hybrid DCT study design to implement in interventional oncology,” says Gaskill. “My goal is to support all stakeholders in making decentralized studies happen—increasing access to patients and furthering our efforts in diversity.”

Sponsors have often tended to have preferred technologies that sites are asked to use. “Since the pandemic, sites typically have in place the technology needed to support decentralized study elements,” states Gaskill. “If we listen to our sites and leverage existing site platforms, there may not be a need to invest in new technology or vendor services to implement DCTs or hybrid studies. This helps minimize the burden for site staff of having to learn a new system for each trial. The site-centric approach also decreases complexity and principal investigator (PI) oversight burden.”

Gaskill explains that the guidance supports the fact that the PI does not necessarily have to be physically present with patients who are receiving standard of care, but they can provide oversight via a combination of telemedicine and having access to the patient’s electronic health records—amongst other platforms that are already embedded in the site.

Building Sponsor Confidence in Sites’ Abilities to Run DCTs

Join Noelle at ACRP 2024 [May 3–6; Anaheim, Calif.], as they explore two different site networks and at a high level, with an emphasis on how they and their sponsors worked to comply with regulatory guidance in two different DCT study designs. View complete schedule.

“By adopting the site-based models and technologies, we expect the hybrid study to be cost neutral compared with the original protocol, with improved enrollment and diversity due to the ability to reach patients where they are,” notes Gaskill.

The hope is that the industry as a whole will benefit from learning about these real-world examples of studies with decentralized elements, using practical examples from sites that have launched their own efforts. Gaskill concludes that “the key to success is to approach the model from the sites’ perspective, using technologies that they already have in place, and taking account of input from site staff to implement all key study elements.”

Reference

  1. https://www.fda.gov/media/167696/download

Edited by Jill Dawson