About the Project

In this project, the term ‘Remote Methods of Trial Delivery’ reflects all activities related to trial delivery that can be undertaken without the need for in-person, face-to-face contact. Some examples are shown in the figure.

How was the project set up?

In September 2020, the National Institute for Health and Care Research's Research Delivery Network launched the Remote Methods of Trial Delivery Project, in response to changes to clinical trial design and delivery during the pandemic.

This graphic that visualises that participants, families and their care partners should be the central focus of clinical trials, this is followed by a ring of concentric circles visualising the underpinning layers of research. During trial set up researchers should always consider the patient as a priority and take into consideration the following elements: participant experience, care partner engagement, participant acceptability, participant training and participation support should be considered as a priority. This is followed by the four key elements that underpin research, such as: recruitment and consent, intervention delivery, outcome measurement and quality assurance. The outer layer demonstrates the impact of research design and CTUs, life science industry, charities and funders, healthcare organisations, regulators and ethics and lastly future principal and chief investigators.

How was the website launched?

This revised website was launched on 24th November 2023, in an event with over 200 attendees including representatives from multiple professions involved in trial design, oversight and delivery, as well as members of the public. The event generated rich discussion, which informed final additions to website content. The launch event marked the end of the Remote Methods of Trial Delivery project. You can watch the presentations by clicking on the links below:

Decentralised clinical trials Background & Wider Landscape (Isla Mackenzie) - Click on the link to download the audio transcript
Project Initial Phase (Jane Masoli) - Click on the link to download the audio transcript
Project later phase and stakeholder engagement (Puvan Tharmanathan) - Click on the link to download the audio transcript

During the dissemination event, we facilitated an interactive discussion with panel members. Most of the questions raised focused on the distinctions between traditional and remote methods, such as potential differences in costing, strategies for managing personally identifiable data and workarounds for biological sampling. Here is a summary of the main issues and themes.

Inclusivity: Digital literacy might impact inclusivity when conducting trials remotely, disproportionately affecting some demographic groups. This should be accounted for in the trial design (ideally in a co-creation approach) and weighed against the benefits of other aspects of inclusivity, such as geographical reach. A hybrid delivery approach might work better, with appropriate training and on-going support provided for participants.

Oversight: The chief investigator is ultimately responsible for trial oversight, with principal investigators being responsible for site-level delivery and conduct, although the extent of involvement might vary with the trial. Remote methods may support the growth and development of PIs from other professions, including nursing and allied health professionals. Conversely there could be more super-centre run trials with less need for local PIs with decentralised trials.

Training: Additional training may be required for study teams to effectively navigate the various new challenges encountered when conducting trials remotely. Alongside nurses and clinical staff, having IT professionals can be helpful to support participants. Working remotely can lead to feelings of isolation among staff. Consideration should be given to whether the same staff mix as in traditional trials is required or if adjustments are needed. Upskilling in IT and technology is often crucial for most individuals involved in these methods.

Costs: Adequate resourcing is fundamental to the design and successful delivery of a trial. When implementing different approaches, variations in costs are inevitable, particularly in flexible designs involving a mix of remote and in-person contact. Introducing a costing envelope for trial delivery may be necessary, requiring the support and alignment of funders to this innovative approach. Cost comparison between remotely and traditionally delivered trials remains uncertain. There may be additional costs for IT support, technology, devices, and accessing data from healthcare records, but savings may be made on requiring fewer site visits.

Secure communications: Specialised systems with high security measures are being developed. In the meantime, the emphasis is on minimising the information sent via email to participants, particularly sensitive data.

What were the project aims & objectives?

We aimed to share learning and good practice in relation to remote methods of trial delivery to help patients and their families, the clinical research community and wider life sciences sector to understand:

What remote methods of trial delivery means
The potential benefits and risks to adopting and using remote methods of trial delivery
The considerations for adopting remote methods of trial delivery
What guidance and information exists on remote methods of trial delivery
The implications: there will be both intended and unintended consequences
Requirements in terms of infrastructure, skill base and workforce
If assumptions regarding equivalence with in-person methods are supported by evidence
The potential for methodological innovation

Project Governance

The project was led by Prof. Camille Carroll, NIHR Specialty Lead for Neurodegenerative Diseases and Professor of Clinical Neuroscience at Newcastle University and the University of Plymouth. The project's steering group, co-chaired by Prof. Carroll and Dr Jennifer Harris (Director of Research Policy, The Association of the British Pharmaceutical Industry (ABPI), included representatives from across academia, industry, charities, regulators, funders and patient and public communities.

Achievements and Outputs

The project engaged with over 100 individuals from across the patient and public community, life sciences sector and healthcare system through workshops and surveys in 2020 and 2021. These helped to:

Scope the possible benefits, risks, considerations and enablers of remote methods of trial delivery
Explore the impact of remote methods of trial delivery for clinical trial participants and the research and healthcare sectors in the UK
Identify ways the UK could become world-leading in the adoption and use of remote methods of trial delivery
Collate existing guidance resources and helpful information on remote methods of trial delivery

Further Information

If you're interested in reading more about our stakeholder workshop in 2021, click on the link to view the NIHR Remote Methods of Trial Delivery Report
To read how the NIHR project is solidifying UK’s remote trial delivery know-how, click on the link to view the PharmaPhorum website
To listen to a podcast by Prof. Camille Carroll on the role of digital technology in clinical trials, click on the link to visit the Soundcloud website
To read the more about how the project started, click on the link to view the Remote Methods of Trial Delivery Phase 1 project report
To read a publication from the first phase of the project, click on the link to view the PubMed Website

How has the project achieved this?

Between October 2020 and December 2020, we undertook a series of meetings and surveys (of professionals and the public), with the Working Group drawing together the strands of work to create our initial website in March 2021. In 2021, we held a series of scoping discussions with a range of stakeholders and a stakeholder workshop in November 2021, importantly emphasising the voice of the participant. In 2022 and 2023 we worked with an expanded steering group and broader panel of public contributors to refresh the content of the website and communicate about the project.

The stakeholder workshop was held virtually via zoom, which allowed broad participation of people from across the UK.

Remote Methods of Trial Delivery Stakeholder Workshop November 2021

During the RMTD stakeholder workshop everyone had the opportunity to share their personal and professional perspective on remote methods. You can read some quotes from people who attended the workshop below.

In the stakeholder workshop we discussed:

The benefits and risks for trial participants
The benefits and risks for healthcare in the UK
Existing guidance
How to maximize what the UK has to offer to support international collaborators and the Life Sciences industry

The four infographics show what was discussed during the stakeholder workshop in 2021

“For many patients, RMTD can be frightening, especially the elderly. Often people don’t trust technology and rather speak to people face-to-face, or they are not tech-savvy” Public Representative

“I participated in a partially remote trial that used Fitbits. I was provided information on how to use it and how to access my data. It was monitored by the hospital and participants received follow-up calls. Different age groups were included. I only had to go to the hospital twice. It was successful.” Patient Representative

“Very aware of digital divide and also geographical challenges. Sometimes the geographical challenges can be ameliorated by digital solutions” NIHR Representative

“I am concerned that the introduction of more RMTD will send the message that people should not leave their home. If people live alone this could isolate them further. We need to consider the impact on mental health”

“A hybrid model is a great idea and more inclusive” Researcher

Who has the project team engaged with?

The RMTD steering group has engaged with 60 patient and public representatives during the course of the project. The steering group had two patient representative members, who attended meetings. They shared their valuable insights, knowledge and perspectives to help steer and guide decisions, ensuring that patient voice was always central during the decision making process. 11 patient representatives attended the stakeholder workshop; their input and engagement during this event contributed to the workshop report, which has informed the development of this website guidance for both patients and practitioners.

The project team has engaged with over 100 individuals from the life sciences sector through virtual workshops in 2020 and 2021. We have engaged with 60 patients and public representatives including carers through virtual workshops and surveys. The project team consists of 39 members including representatives from academia, charity and industry and regulators. Lastly, through the course of the project we have presented at 15 conferences, events and meetings to raise awareness of the project.

Remote Methods of Trial Delivery Steering Group Contributors:

Chair

Prof. Camille Carroll – National Specialty Lead Neurodegenerative Diseases

Members

Abigail Pardoe - Cluster E Manager
Alastair Nicholson - Head of Coordination and Standardisation, HRA
Andrew Fisher - Lead Senior GCP Inspector, MHRA
Ava Pedersen - Cluster E Administrator
Dr Ben Underwood - Dementias Local Specialty Co-Lead
Catriona Manville - Policy Officer AMRC (Association of Medical Research Charities)
Carolyn Young - Neurodegeneration National Specialty Group Member, NIHR
Candice King - Patient and Public Involvement and Engagement Representative
Prof. Chris McDermott - Motor Neurone Disease Lead
David Ashford-Jones - Patient and Public Involvement and Engagement Representative
Della Ogunleye - Patient and Public Involvement and Engagement Representative
Denise Wilson - Business Development Manager, Research Delivery Network
Prof. Eamonn Maher – National Specialty Lead for Genetics
Gareth Baxendale - Head of IT Operations and Technology, NIHR
Dr Gary Nestor – Head of Cluster (Research Delivery Network)
Gillan Murphy - Patient and Public Involvement and Engagement Representative
Isla MacKenzie - Clinical Professor (Teaching and Research), Trials @ Home
Jameel Muzaffar - Consultant ENT Surgeon & ENT National Specialty Lead
James Wason - Newcastle University
James Williamson - Research Delivery Lead, NIHR
Jane Masoli - Ageing National Specialty Group Member, NIHR
Jennifer Harris - Head of Research Policy, ABPI
Prof. John O’Brien – National Specialty Lead for DeNDRoN Dementias (Chair)
John Sheepy - Patient and Public Involvement and Engagement Representative
Kevin McFarthing - Patient and Public Involvement and Engagement Representative
Dr Khalid Ali - Ageing Local Specialty Lead & Stratified Medicine Champion
Kim Down - National Specialty Cluster Manager (Research Delivery Network)
Prof. Klaus Schmierer - Deputy Neurological Disorders Local Specialty Lead
Leigh Boxall - Senior Patient Recruitment Lead, IQVIA
Lorna Allen - Patient and Parent Involvement and Engagement Representative, Cystic Fibrosis Trust
Lucy Culliford - Senior Research Fellow in Clinical Trials, CTU
Prof. Lynn Rochester – National Specialty Cluster Lead, Research Delivery Network
Martin O'Kane - Head of Clinical Trials Unit, MHRA
Prof. Miles Witham – National Specialty Lead for Ageing
Natalie Wilson - Business Development Manager, Research Delivery Network
Prof. Peter Goadsby - National Specialty Lead for Neurological Disorders
Pippa Corrie - Consultant and University of Cambridge Associate Lecturer in Medical Oncology
Puvan Tharmanathan - Senior Research Fellow (Associate Professor) University of York)
Dr Rob Angus - Consultant Respiratory Physician
Dr Ross Dunne - Dementias Local Specialty Lead
Shamaila Anwar - Cross-Specialty Senior Project Lead
Shane McKee - Genetics Devolved Nation Specialty Lead
Sharon Hudson - Mental Health Specialty Lead (Chair)
Stacy Young - Motor Neuron Disease Clinical Studies Group Co-ordinator
Tom Baggeley - Policy Officer, AMRC

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