Patient convenience has emerged as the single biggest trend in the clinical trial industry over the past two turbulent years. Placing patients at the center of conducting clinical research is of the utmost importance, but comes with complexities. The COVID-19 pandemic has led to an increase in decentralized clinical trials, and while this works well for some trials, there can be disadvantages as well.
 
Zach Hales, Associate Director at Greenphire, discusses the downside to the rise of decentralized trials, specifically how they can negatively impact clinical investigator sites, where medical professionals interact with patients and conduct trials. –KB
 
Contract Pharma: What are some of the key benefits and disadvantages of decentralized clinical trials?
 
Zach Hales: Benefits of decentralized trials include:
·       Continuation of trials, especially during COVID – while maintaining the safety of participants and sites
·       Participant flexibility – giving options as it relates to receiving care where applicable and necessary (e.g., going to the clinic vs. local labs and even in-home or virtual visits)
·       Increased retention and compliance by reducing the burden on the participant while minimizing disruptions day to day
·       Far larger reach in terms of participant enrollment (supporting increased diversity) – historically, traveling to a research site may have deterred potential participants, whereas the flexible trial model may be more appealing to broader population

Disadvantages of decentralized trials include:
·       Lack of personal touch and connection between sites and participants
·       Additional technology to manage
·       Manage / Process higher volume of data coming from technology
·       There may be additional or at least new costs related to remote trial technology
 
CP: How are sites adapting to the technology needed for these trials?
 
ZH: Decentralized trials and the use of technology in clinical research is not a new concept. While COVID-19 certainly highlighted the need for decentralized trials and supporting technology, sites have been adapting to innovation for years.
 
Introducing change may feel strenuous at the outset but ultimately, sites want to stay ahead of the curve and be a part of the technology revolution. Once trained on the systems and their value properly communicated, sites understand that the goal of technology is to reduce manual efforts that can hinder research. When implemented and adopted successfully, sites are seeing the benefits of streamlined workflows and reduced burden for themselves and participants alike.
 
CP: How can the struggles sites face impede the move to decentralized trials?
 
ZH: Decentralized trials are intended to enable flexibility of care but can also introduce increased burden on sites. One challenge that has been consistent across many sites is cashflow management. Over half of clinical trial investigator sites have less than three months of operating cash on hand, according to the Society for Clinical Research Sites. This hurdle was only intensified during the pandemic due to unforeseen costs (e.g., additional equipment and technology). The financial strain even led to loss of staff in many cases – stemming from the need to reduce wages. In order for decentralized trials to be feasible, sponsors and sites must work together to understand and mitigate many of these challenges.
 
CP: How can sponsors work with sites to help resolve these issues?
 
ZH: Beginning with trial design, it is crucial for sponsors to take both participants and sites into consideration (e.g., factoring additional costs into the budget). This may include working with site and participant advocate groups when building the protocol. In addition to design, sponsors should introduce process efficiency wherever possible. This is often in the form of technology, which will ideally streamline workflows and simplify data collection and participant engagement without adding work for site staff.
 
Critical to successful technology implementation is site training and communication of value-add. If sites understand how to use the solutions they are given and see the benefit, tech will be embraced and adopted. Additionally, interoperability across platforms is key. Introducing technologies that can integrate with one another – whether allowing for Single Sign-On (SSO) or data triggering payments – will help to reduce time-consuming processes.
 
CP: Do you anticipate in-person patient visits to sites will remain? Why is this important?
 
ZH: Yes, I believe in-person visits will always remain an essential part of clinical trials. Though we have seen a rise in decentralized trials, inclusive of in-home care, telemedicine, use of technology for data entry (e.g., eCOA/ePRO), etc., certain studies / protocols (i.e., interventional) require participants to visit the clinic for completion of physical procedures.
 
Additionally, participants appreciate the relationships they build with site staff and investigators; this adds to their trust in trials and the care they are receiving. In fact, according to the 2021 Perceptions and Insights Study conducted by CISCRP, nearly 90% of trial participants with a medical condition said that they are “somewhat willing” or “very willing” to travel to the clinic for an in-person visit. As such, sites will remain central to study success, and they should feel confident in the role they play in clinical research.