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Supporting Investigators and Sites in the Evolution to Decentralised Clinical Trials

The growing uptake of decentralised clinical trials in recent years reflects several key drivers such as advances in remote monitoring technology and data analytics, the need to access broader, more diverse trial populations, and demand in clinical development for cost efficiencies and more meaningful, real-world study outcomes.

However, we are at a point where if this approach is really to be considered business as usual, it needs to have acceptance by and support from all stakeholders, including investigators and site staff.

Historically, the physical interface between sites and study participants was the primary connection in clinical trials. While decentralised clinical trials may ease patient burden and potentially some administrative burden on sites, they can also raise concerns about loss of direct patient contact and revenue generation.

It is therefore critical that sponsors communicate effectively with their sites about how associated services, such as in-home services, will work to the advantage of not just the patient but the investigators and site staff also. Sponsors should also ensure they provide the right support and appropriate training to ensure that these advantages are recognised and exploited at the site level.

A few years ago, ICON conducted a survey to get a pulse check on site sentiment and their experiences during the COVID-19 pandemic, when decentralisation really took off. At that time, the survey found that nearly 70% of site staff had little or no experience of remote processes before the pandemic. Nonetheless, more than 78% of staff felt remote processes were to their benefit, while over 90% were expecting to see more decentralisation. It showed that there is an understanding and an acceptance that decentralisation of clinical trials is here to stay and will only grow.

The varying levels of experience and capability that sites have in managing decentralisation depends to some extent on the health care system they operate within. Across the board, exposure to related processes and technologies increased under pandemic conditions, but exposure and being equipped with the skills to use such decentralised technologies are two different things. The onus is firmly on sponsors and their partners to ensure that sites still feel comfortable with the changes and bring them on the journey.

Shifting Administrative Burden and Workload from the Site One potential benefit of decentralised clinical trials is a reduction in administrative workload for trial sites. For example, recruitment presents a significant workload challenge for investigators as well as trial sponsors. Digital patient recruitment strategies can reduce the burden from sites and support the reduction of overall timelines.

As patient assessments are increasingly conducted through digital health technologies capable of primary data capture, less time is needed to interact with clinical research associates (CRAs) on clinical monitoring. In a decentralised clinical trial setting, much of this activity is automated and digitalised.