The COVID-19 pandemic had an immediate impact on clinical trial delivery and provided an opportunity for rapid, systemic change. There was an immediate removal of former barriers to restructuring towards a remote delivery approach. The Remote Trial Delivery Working Group recommended five key principles of Remote Trial Delivery and developed a toolkit to guide researchers, underpinned by a targeted literature review and surveys of research professionals, participants and carers. As well as the key principles and toolkit, we have assembled a repository of good practice examples available on our website.
The speed of change away from face-to-face delivery without clear methods and signposting undoubtedly led to rapid development of innovations in research planning and delivery, from which valuable lessons can be learned. The wider societal shift to remote working has provided considerable upskilling in digital communications and introduced innovative, technology-supported ways of working, reducing the need for physical meetings. Participants and researchers described significant benefits of remote delivery of some aspects of clinical trials in addition to reduced COVID-19 infection risk. For example, broader reach and inclusivity in IT enabled groups and improved efficiency and flexibility for both research teams and participants. In addition, once the infrastructure is sufficient to support remote trial delivery with centralisation of processes, Remote Trial Delivery is likely to reduce the costs and environmental impact of clinical research.
However, the benefits of Remote Trial Delivery are not universal, and significant knowledge gaps remain. Importantly, Remote Trial Delivery most frequently involves the use of online platforms, or applications, which can introduce bias in participant recruitment and ability to participate. The “digital divide” is the gap between people in society who have full access or skills to enable the use of digital technologies, such as the Internet and computers, and those who do not . In the UK, the main factors influencing the digital divide are age, region, socioeconomic status and whether a person has a disability . Other important factors to consider with facilitating accessibility are language barriers and the requirements of under-served groups. Following COVID-19, research will be needed to establish how the wider use of the Internet and video conferencing has altered access and familiarity with online communication. This should be considered when planning and delivering clinical trials. It is also essential to have a digitally literate and competent workforce to deliver clinical trials remotely, for all aspects of clinical trial delivery including ensuring a good quality patient experience. This will require the right platforms, processes and infrastructure, for example, access to electronic healthcare records for remote monitoring, the ability to store, manage and transfer electronic documents and appropriate electronic consent platforms.
The research professionals’ survey respondents did not consider the intervention as a leading trial component in need of further evidence in order to provide Remote Trial Delivery. In some trials—for example, drug trials—the intervention delivery may not be significantly altered by remote delivery, which may be why this was not considered a higher priority. However, a major potential limitation of Remote Trial Delivery is that there is currently insufficient evidence to support the validity of many specific interventions and assessments when delivered remotely and more research is required. Equally, quality assurance processes need to continue to be rigorous, including monitoring of data integrity and oversight processes sufficient to meet the appropriately high standards of regulators. Providing sufficiently rigorous regulation while enabling innovation is a further challenge. Standards for metadata to support digital health technologies in clinical research  and frameworks for Biometric Monitoring Technologies  have been proposed. However, there is no formal standard that is widely accepted. In addition, the participant voice in not feeling valued in the same way as in previous trial experiences or having the same personal interactions with the research team may impact on the recognised benefit of being enrolled in clinical trials regardless of the intervention group, as well as reducing willingness to participate and retention in follow-up.
The potential advantages and disadvantages of Remote Trial Delivery that we have outlined are in keeping with previous reports. The Trials@Home group released a first set of recommendations for remote delivery of clinical trials in August 2020 , based on a systematic literature review and a consortium of public and private partners. The themes that they described of potential advantages and limitations correlate well with our findings. There is a growing industry drive to decentralisation and remote delivery of clinical trials citing improved participation opportunity, trial efficiency and quality, with some of the transformation and decentralisation drives receiving cross-sector support including government, patient groups, sponsors, professional societies and academic institutions .
This NIHR Remote Trial Delivery Working Group formed from a broad range of national stakeholders has delivered a consensus opinion on the key principles of Remote Trial Delivery and a toolkit for researchers to use when planning remote delivery. This work included patients and participants as key members of the Working Group and designed and implemented separate surveys for participants and research professionals. This adhered to the goal of keeping the participant as the central focus of this work. This approach enabled us to present the participant views, as well as the overall themes of potential advantages and disadvantages of Remote Trial Delivery.
Similar to the report from the INCLUDE group , the Remote Trial Delivery Working Group conducted this work as a focussed, time-limited project. This work needed to be expedited to provide a toolkit and recommendations at a crucial period of service re-design in clinical trial delivery due to the COVID-19 pandemic. This led to some compromise in the approach. Firstly, the literature was not reviewed using a prespecified protocol or a systematic search. Secondly, surveys, while widely circulated via national networks, were time limited and targeted. We recognise that the participants and carers surveyed represent those on the privileged side of the digital divide and are not a representative sample of the overall participant population. Almost all respondents to our surveys were from England; other localities may experience different challenges and enablers which we were not able to explore. In addition, almost all of the respondents to our patient/carer survey were white, limiting our ability to explore aspects of relevance in other ethnic groups, such as trust, accessibility and language. As these surveys were conducted during the acute phase of the COVID-19 pandemic, they capture a period in which the majority of experience may relate to COVID-19 studies or work-arounds to maintain studies that were unable to continue if not remotely delivered. Ongoing work is required to understand remote trial delivery when clinical trials are less restricted.
The NIHR is supporting the development of complex and innovative trial designs, such as those with virtual, decentralised or siteless trials . However, further research is required across the research pathway to establish the scientific robustness of Remote Trial Delivery, as well as ensuring that the quality of the participant experience is maintained. This should include validation studies for specific methods and outcome measures, alongside work to assure data quality across the trial pathway. This should be tailored to whether the measure is an existing measurement applied to a different setting e.g. home setting replication, or whether it is a new measure incorporating digital measurement or a novel concept or end point.
We have identified knowledge gaps and developments required in order to optimise the potential for Remote Trial Delivery. These include changes in processes, infrastructure and workforce, especially with technology, data and training. Clinical trial delivery will need to evolve to clinical care pathways of the future , in accordance with the NHS Long Term Plan  in which digitally enabled care will be mainstream. We need to ensure that we build the infrastructure and skills now to support the delivery of hybrid or fully remote clinical trials, building on the principles described.