The future of clinical trials is decentralized and not one size fits all

An Expert View from Fiona Maini, principal, global compliance and strategy at Medidata Solutions, a Dassault Systèmes company.

Remote technology solutions in clinical trials, such as electronic patient diaries, and wearables and sensors, have been around for some time, but it’s taken a few years for wider adoption.?These tools?enable patients to participate in clinical trials from the comfort of their own home?or preferred location, and they reduce the burden associated with partaking in ‘traditional’ trials. In trials using such technologies, also called decentralized clinical trials (DCTs), site visits are limited, which provides patients with some flexibility and tools to alleviate the burden associated with manual reporting, such as of drug intake.

In a post-COVID-19 world, it has become obvious that trials often function better when they use these solutions. Prior to the pandemic, these solutions were not as widely available as they are now, and regulatory guidance on their use was not as extensive. The industry’s approach to clinical trials changed as a result of the pandemic, but how exactly has the pandemic played a role in the wider adoption of remote technology in clinical trials, and how supportive have regulators been?

Traditional trials: a ‘one design fits all’ approach

Until a few years ago, clinical trials were conducted largely in person. Patients had to travel to research sites, whether they were a few minutes away or on the other side of the country. These trials were difficult for patients who had to juggle their participation with personal commitments, which often led to disengagement, hindering retention. In contrast to traditional trials, DCTs are not ‘one design fits all’, they engage patients in the trial process and, with on-site visits not required as frequently, provide patients with more flexibility. Additionally, technology vendors and software providers are engaging patients at the design phase of digital tools and solutions to truly ensure they are patient-friendly. The pandemic played a role in highlighting the considerable limitations of traditional clinical trials and provided the impetus for the industry to adopt these solutions.

The COVID-19 pandemic: impact and regulatory support

COVID-19 had a significant impact on clinical trials. The pandemic meant that the world had to close, with lockdowns restricting people’s movements. The industry was faced with new challenges: travel restrictions, supply chain disruptions, site closures and potential patient/staff exposure to COVID-19. Such challenges meant that trials were not able to progress as they did before. In the face of adversity, the industry worked with regulators to limit these impacts. Regulators were prompt and pragmatic in their approach to limit the impact on operations and clinical trials. The US Food and Drug Administration?published guidance?on the conduct of clinical trials during COVID-19, encouraging sponsors to use remote solutions where possible. The agency also recommended that sponsors and clinical investigators consider “establishing and implementing policy and procedures,or revise existing policy and procedures, to describe approaches to be used to protect trial participants and manage study conduct during possible disruption of the study as a result of COVID-19 control measures at study sites.” The agency suggested that these changes could deal with the impact to informed consent processes, study visits and study monitoring.

In the UK, the Medicines and Healthcare products Regulatory Agency was clear on regulatory flexibility and supported the use of remote monitoring and remote visits. Elsewhere, the European Medicines Agency published guidance on clinical trial management during COVID-19, highlighting the use of remote solutions such as phone and video calls instead of physical visits. As a result of regulators’ support, the industry was able to limit the impact of the pandemic on clinical trial research as much as possible – and ensure patients received experimental treatments and that research could continue.

The industry and regulators’ efforts to limit the impact of COVID-19 meant that clinical trials emerged from the pandemic stronger. According to a?research report?published by Medidata,?92% of clinical trials executives (based in the UK, France, Germany and Switzerland) believe clinical trials are more patient-centric than ever, with the same number of respondents noting that trials always or frequently rely on the use of technology now. This shift has seemingly been aided by regulators, with 57% of respondents believing that the regulatory environment in their country is somewhat supportive of the use of new technological solutions, such as remote patient monitoring and electronic signatures, in clinical trials.

The future of clinical trials is decentralized

The pandemic highlighted the importance of these remote technology solutions – the many benefits of using these solutions cannot be ignored, including by regulators who are conscious of the role they have to play. Earlier this month, the Accelerating Clinical Trials in the EU (ACT EU) program hosted?a multi-stakeholder workshop?on decentralized clinical trials (DCTs) on behalf of the EU DCT project – an important gathering of stakeholders from all areas of the research community to share perspectives on DCTs. During the meeting, the EU DCT project group presented the work of the European Medicines Regulatory Network on collaboration in decentralized clinical trials, including work on an upcoming paper recommending the use of decentralised tools in clinical trials. It is key to moving things forward in Europe as it will set out regulatory guidelines on how clinical trials can use remote technology for the first time. These changes will allow clinical trial operators to invest more in remote solutions and give them confidence in their wider use.

The use of these solutions during the pandemic set new expectations. In the report released by Medidata, around two thirds of clinical trial executives said they believe the use of remote solutions is set to increase, and half of these participants note that patients already expect trials to use remote tools and solutions. These insights suggest that trials will have to evolve to include these tools which provide more flexibility to patients, while stakeholders resisting change risk being left behind. Regulatory flexibility helped us limit the impact of the pandemic, and continuous dialogue with regulators and an openness towards the use of these solutions will continue to drive the industry forward.