Despite clinical trial decentralisation not being a new concept to the industry, many people still perceive it as removing all in-person factors in a study. While decentralised clinical trials (DCTs) do offer the implementation of technological solutions such as remote monitoring or telemedicine, it does not mean that the whole trial will be virtual. With such an end-of-spectrum mindset, questions have arisen over the role of a site in a DCT.
Traditionally, a clinical trial site has been a building where an investigator performs assessments and procedures outlined in a study protocol. Over time, new and transformational models were introduced, such as pharmacy-based sites like CVS and Walgreens or mobile units travelling to trial participants, says Mark Goldberg, CEO of Allucent.
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While the definition of a site evolved, its purpose and responsibility remained the same, namely overseeing all participants’ safety and well-being. Now, there is the potential for some of the actual assessments to be performed in a more convenient location for the patient, says Emily Mitchell, executive director of decentralised clinical trials at ICON. This means that the site’s primary focus is now on the actual care of the disease, rather than the completion of protocol assessments.
Although technology eases the clinical trial conduct for sponsors and participation for patients, sites often face multiple challenges with decentralisation. Additionally, sites are often forgotten in discussions on how to effectively use decentralisation components in trials and certain global regions with limited access to technology can find themselves being left behind the curve.
Remaining DCT challenges for sites
The use of technology in clinical trials is not new, as electronic data capture (EDC) was introduced in the 1990s. Even though technology has been used for decades, sites still find it difficult to manage all of it, says Paul O’Donohoe, senior director of eCOA Product and Science at Medidata. “We’re just continuing to ramp up the amount of technology that we’re asking sites to interact with and manage,” he adds.
The technology-related burden has shifted from hardware to software challenges. As sites develop internal hardware capabilities, they must deal with multiple software applications and logins from different sponsors. “It is really easy to lose sight of how many studies some of the sites are running at the same time,” O’Donohoe notes.
As a result of decentralisation, sites also have to manage the technology that is required by patients, such as remote monitors or sensors. Sites need to understand how these tools work and teach patients how to interact with them, says Kyle Hogan, president of Datacubed Health. “Far too often, we have left that challenge with the site without sufficient support,” he adds. Sites run the risk of becoming an information technology (IT) helpdesk. Hogan explains that there is a big difference between helping to enable a patient and being a helpdesk for a DCT vendor.
According to Goldberg, one of the largest burdens is site training and education on how to reshape the practice to operate more efficiently in the DCT world. Sites showed resistance when EDC was introduced, and the same outlook can be seen now. However, organisations can become far more efficient and profitable as sites by using decentralised approaches, he adds.
Healthy competition or fuelling disparity?
While sponsors and their partners should ensure that sites receive much-needed support and training, being a DCT-friendly site can be a competitive advantage. Typically, sponsors look for sites with access to identified patient populations and experience in running similar trials rather than technology management, explains O’Donohoe.
However, the ability and willingness to run a DCT does gives a site the opportunity to differentiate itself from others. Implementing decentralised elements into practice can also allow sites to expand their geography and find more patients, Goldberg notes.
While some level of competition is healthy, only sites with access to technology can compete, leaving others behind the curve. According to GlobalData’s Clinical Trial Database, more than 11,000 sites that have conducted or initiated a trial with a DCT component are in the US. Large numbers of such sites are also based in the UK, Germany, Japan, and China. GlobalData is the parent company of Clinical Trials Arena.
The disparity of sites conducting DCTs in regions like Africa or certain countries in Asia might reflect the low clinical trial activity overall, O’Donohoe notes. However, it is a fair concern that ramping up the technology requirements for sites to engage in these studies risks emphasising that disparity, he says. Hogan says that sponsors and vendors need to provide the technology required for the trial to patients, such as smartphones, and ensure that they have data coverage if an internet connection is needed to transmit data and information.
According to Mitchell, sponsors should offer options on how a site can decide to engage with a study. This would ensure that countries without a regulatory framework can conduct a DCT and are not excluded from participation.
Sponsors also need to understand the local culture before implementing decentralised components. For example, some communities are secretive about their health, and participants do not want a nurse entering their home or owning a device that might put the participant at risk.
However, this does not mean that Western countries have solved all these problems, says Goldberg. Researchers found that decentralisation creates a technology divide among potential participants, as access to the internet or smartphones is less prominent in certain communities.
Ironically, to improve limited access to technology, the industry needs to introduce technological solutions. “If we're meaningfully trying to widen the diversity of countries that are involved in clinical trials, then we shouldn't be afraid to take those steps to empower the use of the technologies,” O’Donohoe notes.
Site perspective matters
As time goes on and the discussion shifts from virtual to hybrid trials, the industry will start to think about decentralisation in a more realistic and sustainable way. As such, sites disappearing from the clinical trial industry will become less of a threat than it was thought initially, says Goldberg.
Even in DCTs, sites still need to have medical safety oversight and to build a relationship between a patient and a clinician when needed. Mitchell explains that an oncology participant will want to see, talk, or be hugged by their doctor if they get a new diagnosis, whereas a patient in a long-term registry filling out electronic patient reported outcomes (ePROs) may not need that interaction.
Nevertheless, the industry needs to work on minimising the burden on sites. Elevating the importance of the site experience as much as the patient experience will have a variety of positive knock-on downstream effects on the success of that clinical trial, O’Donohoe says.
DCTs have been driven mostly by considerations related to patients and by offering them flexibility, but now is the time to introduce sites into the conversation. Sponsors need to have early engagement with sites so they can start to have a voice in how protocols are developed, Mitchell says.
“We need to not just focus on patient centricity, but also on delivering site centricity,” she adds.
Decentralised Clinical Trial coverage in Clinical Trials Arena is supported by Huma.
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