A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond

Abstract

Background Prior to the COVID-19 pandemic, the majority of clinical trial activity took place face to face within clinical or research units. The COVID-19 pandemic resulted in a significant shift towards trial delivery without in-person face-to-face contact or “Remote Trial Delivery”. The National Institute of Health Research (NIHR) assembled a Remote Trial Delivery Working Group to consider challenges and enablers to this major change in clinical trial delivery and to provide a toolkit for researchers to support the transition to remote delivery. Methods The NIHR Remote Trial Delivery Working Group evaluated five key domains of the trial delivery pathway: participant factors, recruitment, intervention delivery, outcome measurement and quality assurance. Independent surveys were disseminated to research professionals, and patients and carers, to ascertain benefits, challenges, pitfalls, enablers and examples of good practice in Remote Trial Delivery. A toolkit was constructed to support researchers, funders and governance structures in moving towards Remote Trial Delivery. The toolkit comprises a website encompassing the key principles of Remote Trial Delivery, and a repository of best practice examples and questions to guide research teams. Results The patient and carer survey received 47 respondents, 34 of whom were patients and 13 of whom were carers. The professional survey had 115 examples of remote trial delivery practice entered from across England. Key potential benefits included broader reach and inclusivity, the ability for standardisation and centralisation, and increased efficiency and patient/carer convenience. Challenges included the potential exclusion of participants lacking connectivity or digital skills, the lack of digitally skilled workforce and appropriate infrastructure, and validation requirements. Five key principles of Remote Trial Delivery were proposed: national research standards, inclusivity, validity, cost-effectiveness and evaluation of new methodologies. Conclusions The rapid changes towards Remote Trial Delivery catalysed by the COVID-19 pandemic could lead to sustained change in clinical trial delivery. The NIHR Remote Trial Delivery Working Group provide a toolkit for researchers recommending five key principles of Remote Trial Delivery and providing examples of enablers.

Can learnings from the COVID-19 pandemic improve trial conduct post-pandemic? A case study of strategies used by the DISC trial

“…18,19 In the UK, optimising RCT delivery using remote methods is a key piece of work being developed between research funders and regulators. 20…”

“…18,19 In the UK, optimising RCT delivery using remote methods is a key piece of work being developed between research funders and regulators. 20 The DISC survey and site investigators meeting identified a number of problems effectively and is an approach recommended for ongoing/future trials. Communication with study sites to identify what barriers exist so that solutions can be developed is a proven effective strategy to improve recruitment rates.…”

Clinical research nurse utilisation and role in the conduct of decentralised clinical trials: a literature review

“…The CRN is an expert in the conduct and adherence to the clinical trial protocol (Godskesen et al, 2018: 475–485). This expert knowledge related to assessments, participant visit schedule and the investigative medicine/device is critical to the safety of the participant (Masoli et al, 2021: 911). As the DCT design enables participants to receive novel treatments via research studies/clinical trials at home, this expert knowledge allows the CRN to accommodate for differences in care delivery environments (home instead of hospital or research centre).…”

“…In the rush to implement remote/virtual trials under the DCT model, there is a paucity of literature surrounding the specific communication skillsets required by CRNs to align with community cultures, participants and varied industry sponsors. Current literature surrounding DCTs omits the description of CRN education requirements unique to DCT conduct compared to on-site research conduct (Apostolaros et al, 2020: 779–787; Masoli et al, 2021: 911). Without familiar equipment, resources or surroundings, research nurses require education relating to home-based nursing and how it complements existing research-based training.…”

Using Digital Tools in Clinical, Health and Social Care Research: A Mixed-Methods Study of UK Stakeholders

“…concerns about digital exclusion of research participants who may not have access to digital tools, and/or internet connections, or lack familiarity with using these platforms (e.g.,1,[16][17][18]. exclusion by providing training on digital tools in various modalities (e.g., videos, face-to-face) to increase research participant's/staff confidence in use and providing a physical location and/or digital tool in order for people to participate in a study.…”