Current situation
In March 2020, most ongoing clinical research studies at St George’s were suspended due to the Covid-19 outbreak. All of our clinical research studies were reviewed, and the only studies which have continued or commenced are:
- Covid-19 clinical research studies
- studies where patient safety and care would be compromised if the study was suspended, however these studies were suspended to new patient recruitment.
Given the easing of the pressures on the NHS, we are now in a position to begin to move towards re-opening clinical research studies which had been suspended, whilst ensuring that the Covid-19 studies which we have can fully continue. We can also look towards starting new clinical research studies - during the last three months Joint Research and Enterprise Services (JRES) has continued the study set up process and there are several studies which are ready to start as soon as the situation allows.
The National Institute for Health Research (NIHR) has produced ’A Framework for restarting NIHR research activities which have been paused due to Covid-19’
Based on the principles laid out by the NIHR, St George’s approach to restarting clinical research is set out as follows.
Scoping for restarting/starting research
As when research was suspended in March 2020, we will need researcher feedback on their reediness and ability to (re)start non-COVID research. JRES will contact all Chief/Principal Investigators with a spreadsheet of all research projects within their area, and researchers will be asked to complete the (re)start consideration sections for each project to allow us to determine the readiness to proceed.
Preconditions for restarting/starting research
There are a number of preconditions which we need to ensure are met before clinical research studies can restart or start. These cover the areas of study viability; safety; and capacity & site readiness.
1. Study viability: Only research which is still viable should restart/start
Assurances required:
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that the sponsor and/or funder have assessed and agreed to start/restart
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that all regulatory approvals are in place, with any necessary amendments made (including to reduce risk)
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that necessary research funding is confirmed, including any additional funding which is required
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whether there are any changes to the protocol and/or timelines
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that funding to meet any Excess Treatment Costs been confirmed, including any additional funding which is required
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that the sponsor and funder are satisfied with the arrangements for patient and public involvement in the study.
2. Safety: Research should only restart/start when safe to do so
Assurances required:
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that risk of exposure to Covid-19 for patients and staff has been mitigated
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that physical access complies with government restrictions on social distancing
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that any special requirements for patients who are considered ‘clinically extremely vulnerable’ who are ‘shielded’ have been put in place (their GP or specialist should be consulted to ensure that they continue to receive the appropriate care with only essential visits to the research site)
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that an assessment of the need for patient Covid-19 testing and the requirements for personal protective equipment (PPE) have been completed
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that we are able to comply with protocol and regulatory requirements
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that study arrangements comply with St George’s policies in respect of Covid-19
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that clear guidance on safety issues and precautions can be provided to patients and staff
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that patients will be asked and reassured about any concerns regarding Covid-19 - patients need to feel safe and confident
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where possible, remote visits are conducted in agreement with the sponsor
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where face-to-face and or onsite visits are required that these are integrated into routine clinical encounters and there is agreement for clinical space use
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that the requirement, processes and safety for study monitors /meetings has been assessed and where possible conducted remotely
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that any mitigations or flexibilities put in place to restart a study do not have an adverse impact on patient safety.
3. Capacity and site readiness
The pace of restart and commencement of new studies should be commensurate with capacity and readiness
Assurances required:
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that the Chief/Principal Investigator and research staff needed to conduct the study have the capacity to do so
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that the clinical service is ‘open for businesses’ to the full extent required for the study
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that all necessary supporting departments (e.g. pharmacy, pathology, radiology) have the necessary resource and capacity
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that all necessary supplies have been procured and are in place, including Investigational Medicinal Products (IMPs) and PPE
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that for suspended studies study data has been checked for data integrity to ensure that data remains robust and/or fit for purpose
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that physical access arrangements for participants have been assessed and are satisfactory
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that research delivery staff are available to support the study whilst the Trust continues to support COVID19 research.
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for studies requiring the use of Clinical Research Facility staff and/or space, that such resources are available.
Prioritisation
We will need to prioritise starting and restarting those clinical research studies that meet the preconditions and are ready to proceed. The NIHR have three priority levels:
Level 1: Essential studies providing evidence for pandemic management, i.e. nationally prioritised COVID-19 Urgent Public Health Research studies.
Level 2: Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life preserving or life-extending treatment not otherwise available to the patient.
Level 3: All other studies (including new Covid-19 studies not in Level 1).
Whilst we will overall prioritise according to the levels above for restarting and starting studies, it is likely that different clinical specialties will proceed at different paces, based on the clinical service, and the resourcing requirements and availabilities.
St George’s Assessment and Prioritisation panel
We will require researchers to complete the spreadsheet which JRES will send detailing considerations for research (re)start on a project level. This will then be reviewed by a panel (chaired by the Associate Medial Director (Research), and including the Head of Research Nursing, JRES representatives and others if necessary) to assess and determine the readiness to proceed to restart/start studies. This will be based on the information provided to show that the preconditions above have been met.
For studies which the panel assesses are able to restart/start, the panel will determine when and in what order studies can proceed.
Formal approval to restart and start studies
Formal written approval to start and restart studies will be given by JRES, and studies cannot restart/start without this written approval from JRES.
Contact and queries
Chief and Principal Investigators are requested to work with JRES on restarting and starting studies, via your Research Governance & Facilitation Officer.
For any queries about the process, please contact the Head of Research Governance & Delivery, Subhir Bedi.
To discuss research staff resourcing, please contact the Head of Research Nursing, Ade Adebiyi.