What Does it Mean for Research Professionals?

• Do you need to change the way in which you identify potential participants? Has the clinical care pathway changed?

• What are the infrastructure requirements for the proposed method of delivery (hardware, software, connectivity)? Are these supported by your organisation and available to potential participants?

• Will remote methods introduce bias? If so, how can this be mitigated?

• Are you able to provide participants with guidance and support in using the remote methods?

• How will you ensure participants feel supported and have the opportunity to ask questions?

• What training provision is there for your team and participants in any new methodologies?

• Are the interventions, assessments and outcome measures validated for the planned use?

• Will some aspects of trial delivery be more difficult (e.g. some safety assessments)? How will this be mitigated?

• Are there any concerns regarding data security as a result of remote delivery?

• Do you need to adapt your processes to ensure data integrity?

• What additional processes for PI oversight do you need to develop?

• How are you going to measure recruitment and retention in the trial, to ensure the remote methods used are appropriate?

• Are you collecting data on the patient experience? If not, should you be?

Potential Benefits

• Broader reach and inclusion of under-served groups

• Increased rate of recruitment 

• Increased contact with study participants, enabled through more flexible and accommodating protocols (e.g. virtual consultations and treatment at home)

• Improved data management and analysis, with reduced errors

• Easier and more real time monitoring of adverse events

• Reduced risk of research fraud

• Opportunity to improve processes e.g. updating documentation

• Improved efficiency and use of resource e.g. via use of electronic rather than paper health records

• Opportunity for engagement of staff with less experience of research delivery, including professional groups not traditionally involved in research

• Potential to support delivery of studies in sites with less experience or infrastructure, closer to patients' homes

• New methodologies might allow for the framing of new research questions

Potential Risks

• More restricted reach and exclusion of under-served groups

• Reduced in person contact with study team resulting in sense of isolation, reduced retention and engagement and loss of communication (verbal non verbal) with study participants

• Participant non compliance (intentional and unintentional)

• Increased burden for participants

• Increased burden for study delivery team (where training upskilling is needed)

• Isolation of trial delivery staff if working away from rest of team

• Threat to privacy and confidentiality including data security

• Lack of in-person supervision over protocol delivery leading to variation in quality

• Impact on safety monitoring in the absence of remote option

• More demand on resources

Enablers

Infrastructure

• Digital infrastructure and standardised systems including electronic health records

• Digital literacy (participants and delivery teams)

• Established and validated processes e.g. for video consultations and remote consent

• Appropriately skilled and expert workforce

Support for Participants

• Provision of guidance, support and peer support with technology and trouble shooting (for participants and delivery teams)

• Multiple channels to communicate with potential participants e g social media, easy to read resources, videos in different languages

• Involvement of key figures within different groups, such as patient and public contributors, grass roots community organisations, research champions, charities and patient organisations to engage the public with remote methods of trial delivery

• Informational material for  carers and patient support groups, who can help and guide participants further

• Ensuring participants are well-prepared and provided with regular on-going support and contact opportunity

• Peer support opportunities for participants (e.g. virtual coffee mornings)

Study Design

• Early engagement with patients in trial design

• Early dialogue with regulators and ethics to explore use of remote methods of trial delivery

• Flexible research protocols and flexible mindset, with appropriate funding models

• Consent and ethics approval in place for remote monitoring

• Assessments and processes developed and validated for remote delivery

Support for Sites

• Provision of guidance and training on protocol adherence

• Workforce training and upskilling opportunities, with easily accessible education material

• Central coordination

Potential Challenges

• Requirement for demonstration of validity/equivalence of processes and measures

• Regulatory acceptability

• Requirement for flexible funding frameworks

• Not all interventions can be delivered remotely

• Inadequate digital infrastructure (including in organisations) and literacy (participants and workforce)

• Adaptations required for inclusivity – e.g. hearing, visual or cognitive impairment

• Requirement for standardised processes for data sharing and harmonisation

The National Institute for Health and Care research (NIHR)'s Clinical Research Network is ready to support you in delivering your innovative clinical trials. Find out more on what the NIHR can offer by visiting the 'Delivering complex and innovative trials' section of the NIHR Website.

Click on the "Resources" tab above to find some helpful resources and guidance.