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December 2, 2021

Sites: The key to patient centricity in clinical research

We’ve heard and used the term “patient centricity” for years now, and with good reason. It’s an important consideration in the healthcare industry, including the clinical research space. But there’s a related issue rarely discussed, although it should be: the relationship between patient centricity and site centricity.

By Juliet Martin

One could argue patient centricity is not possible without site centricity, as sites deliver the patient experience in clinical trials. The best intentions of any sponsor or contract research organization (CRO) make little difference if sites fail to engage with participants. Here are three strategies and examples of how site centricity ensures trial success and a positive experience for your participants.

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Ethical Issues in the Design and Review of Decentralized Research

Decentralizing trends in clinical research are gaining momentum. These include the use of technologies and home health services to facilitate remote research visits and data collection. Such trends hold promise, with the potential to promote participant autonomy by making research participation more flexible, overcome common obstacles to participation (such as inconveniences and costs related to time-consuming travel and in-person site visits), and increase access to research opportunities for historically disadvantaged and under-represented groups. At the same time, decentralization poses unique challenges, including unique data integrity and participant protection issues. In this white paper, we identify the benefits as well as the challenges of decentralization in clinical research, providing a framework to help sponsors and institutional review boards (IRBs) more fully appreciate the ethical issues associated with decentralization and take appropriate steps in the design and review of decentralized research elements.
by Advarra
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Listen to site experiences and suggestions for improvement

Jessica Perry, Director of Patient Centricity at Moderna, is an industry advocate of the important role sites play in patient centricity. In a recent podcast interview with Advarra’s Aidan Gannon, Perry said, “We have to ensure that when we’re looking at trial designs and looking at operationalizing trials, that we are considering the type of burden that we’re putting on the sites.”

Perry went on to note sponsors shouldn’t pass up the opportunity to leverage the experience sites bring to the table and should invite them to share their insights and learnings. “The sites and investigators we work with are incredibly important to us,” she said. “And we want to ensure that we have a true partnership with them.”

Address challenges sites face with process improvements and support

How else can the industry become “site-centric” and better help sites deliver the patient experiences needed for a successful trial? Taking note of the common challenges site leadership describe is a good starting point. The following were previously shared in focus groups with Advarra’s Longboat Platform team:

  • Customize experiences to accommodate physicians and healthcare partners who work differently
  • Accommodate participants of varied types and backgrounds
  • Integrate clinical research activities and support into investigators’ and site staff’s existing workflows
  • Maximize staff efficiency and effectiveness
  • Provide varying materials and resources for effective staff training
  • Establish an effective workflow across sponsor and site technology, and allow sites to utilize their own technology

One can easily imagine how problems in any of these areas could negatively impact the participant experience at the site. An overwhelmed, poorly organized, or inadequately trained site is not well-positioned to deliver on the sponsors’ and CROs’ patient-centric goals. There could be bigger consequences as well, including compromised data and protocol deviations.

A top-20 pharmaceutical company conducted a challenging Phase III breast cancer study in 16 countries across North America, Europe, and Asia. Due to its tight timeline and small participant population, this particular study had very little room for miscommunication or error. By providing custom training, engagement options, guided visits, and more via Advarra’s Longboat Platform, they successfully conducted this complex trial. The support provided by the sponsor and CRO within the Longboat Platform reduced screen failures by 50%, protocol deviations by 21%, and supported twice the participants enrolled per site.

Investing up front pays off

Fortunately, sponsors and CROs have the power to address these issues and improve the clinical research experience for both sites and participants. Advarra’s technology for sponsors, CROs, and sites:

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  • Improves communication and transparency
  • Improves site efficiency
  • Reduces burdens on staff and participants
  • Streamlines the clinical trial experience

Inevitably, lower burden on sites results in more time available for patient care and engagement.

Free Whitepaper
img

Ethical Issues in the Design and Review of Decentralized Research

Decentralizing trends in clinical research are gaining momentum. These include the use of technologies and home health services to facilitate remote research visits and data collection. Such trends hold promise, with the potential to promote participant autonomy by making research participation more flexible, overcome common obstacles to participation (such as inconveniences and costs related to time-consuming travel and in-person site visits), and increase access to research opportunities for historically disadvantaged and under-represented groups. At the same time, decentralization poses unique challenges, including unique data integrity and participant protection issues. In this white paper, we identify the benefits as well as the challenges of decentralization in clinical research, providing a framework to help sponsors and institutional review boards (IRBs) more fully appreciate the ethical issues associated with decentralization and take appropriate steps in the design and review of decentralized research elements.
by Advarra
Enter your details here to receive your free Whitepaper.

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