Update for studies

NHS Projects

The situation with COVID-19 is rapidly changing.

Some NHS trial sites are introducing their own measures and advice about potential halting of patient recruitment into clinical trials. You should take note if you receive such advice and if you have any questions or concerns relating to ethics or regulatory oversight, please raise them with Ruth Nicholson or Lynne Cox.

 

For interventional trials:

 In the event that a trial cannot continue then the usual process should be followed regarding:

  • protocol deviations and safety oversight.
  • Missed trial visits due to a lock down situation or a participant being unable to attend the site would be protocol deviations.
  • If the trial cannot continue to run safely, for example due to lack of trial staff, or restrictions on visits/travel and ability to perform safety assessments then it is expected that appropriate action would be taken which could include Urgent Safety Measures.
  • Safety of trial subjects should always remain the priority, and if halting the trial is the only way to ensure this, then this would be expected.

 

We would therefore ask that you monitor the situation. Mitigation measures should be considered in advance where possible, for example if any amendments would be required, reduced research team numbers, including delegation log review and also delegation of who to contact if the PI is unavailable. Monitors having access to sites will also need to be considered if relevant, or remote monitoring. Risk assessment should be considered in all cases.

Temporary halts to studies will still require reporting as per regulatory guidelines. It should be considered if funders will also need to be informed.

 

In any case where an Urgent Safety Measure is required it should be ensured that all reporting requirements to ethics and regulatory authorities are met throughout the trial. If a local site PI puts in place a USM then this needs to be communicated to the study team and Sponsor immediately.

The MHRA guidance on USMs can be found here,  the trials unit helpline should be called within 24 hours of measures being taken, and no more than 3 days from the date that measures are taken.

 

It is likely that study sites will request information from study teams, or they could potentially suspend recruitment or implement other safety measures. It is therefore advisable that a risk assessment of the study is considered, and in-particular if the target population of the study present with flu like symptoms. Studies that involve hospital areas that could come under additional pressure should also consider if this will cause issues with recruitment or the ongoing running or safety of the study.

 

Reminder- Any temporary suspensions, recruitment halts or other interruptions to clinical trials and studies need to be reported to the Sponsor. For Imperial College London and Imperial College Healthcare NHS studies, please contact Ruth Nicholson.

 

The HRA have decided stop reviewing applications for individual undergraduate and master’s student projects from now until further notice.

Please see this new guidance which relates to health and social care research projects conducted by undergraduate and master’s students: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/

 

 

For further advice please see the following guidance from the HRA and MHRA:

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/Ruth Nicholson

https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19

ICREC-SETREC studies

In light of the situation current situation and the potential impact of Coronavirus on research studies, the research office would like to issue the following guidance. Some sites, ethics committees and regulatory authorities abroad may be issuing their own guidance and measures. Please take note of such advice and if you have any questions or concerns ethics or regulatory oversight, please raise them with Ruth Nicholson  or Lynne Cox.

 

For studies running in the UK that involve healthy volunteers or College staff and students, please be aware of any continuing government or College guidance which may affect study recruitment or study procedures. Studies abroad should consider the current situation in each country where the study is running. 

 

If you are running a clinical trial abroad then please take be aware of the following guidance:

  • In the event that a trial cannot continue then the usual process should be followed regarding protocol deviations and safety oversight.
  • Missed trial visits due to a lock down situation or a participant being unable to attend the site would be protocol deviations.
  • If the trial cannot continue to run safely, for example due to lack of trial staff, or restrictions on visits/travel and ability to perform safety assessments then it is expected that appropriate action would be taken which could include Urgent Safety Measures.
  • Safety of trial subjects should always remain the priority, and if halting the trial is the only way to ensure this, then this would be expected.

 

The above should take into account regulatory requirements of the country where the study is running.

 

We would therefore ask that you monitor the situation. Mitigation measures should be considered in advance where possible, for example if any amendments would be required, reduced research team numbers, including delegation log review and also delegation of who to contact if the PI is unavailable. Monitors having access to sites will also need to be considered if relevant, or remote monitoring. Risk assessment should be considered in all cases.

Temporary halts to studies will still require reporting as per regulatory guidelines. It should be considered if funders will also need to be informed.