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These digests are provided on a monthly basis to the GCP facilitator community.
These digests are provided on a monthly basis to the GCP facilitator community.
They are kindly collated by Professor Allan Gaw, Associate Director for Educational Quality Standards at the National Institute for Health Research Clinical Research Network (NIHR-CRN). This is Allan's final digest for the CRN.
They are kindly collated by Professor Allan Gaw, Associate Director for Educational Quality Standards at the National Institute for Health Research Clinical Research Network (NIHR-CRN). This is Allan's final digest for the CRN.
Clinical Research Digest — June 2021
Next facilitated run of the MOOC
The next run of the MOOC, Improving Healthcare Through Clinical Research, and my last as Lead Educator, started on May 24. If you know of any new research staff or any that need a refresher, they can still sign up for the free four-week course at the link below (Future Learn, May 2021).
https://www.futurelearn.com/courses/clinical-research
When ethics gets personal
A clinical ethicist reflects on whether to enrol her own child in a COVID 19 vaccine trial (Hastings Center, May 3, 2021).
https://www.thehastingscenter.org/should-we-enroll-our-child-in-a-covid-19-vaccine-trial/
Why is Liverpool being used as a test site?
Events are taking place in Liverpool to test crowd safety and check what impact easing Covid-19 rules will have ahead of a full lifting of restrictions later in the year. But why is the city at the forefront of these trials and how do people feel about the city being used as a test site? (BBC News, April 30, 2021). https://www.bbc.co.uk/news/uk-england-manchester-56907072
ICH E6 Revisions
The ICH E6 Guideline for Good Clinical Practice Expert Working Group is holding a free public virtual conference on 18 to 19 May 2021 to provide an update on the progress to revise this important guideline (MHRA, May 7, 2021).
Should vaccine patents be waived?
The US has thrown its support behind a move at the World Trade Organization to temporarily lift patent protections for coronavirus vaccines (BBC News, May 7, 2021). https://www.bbc.co.uk/news/world-us-canada-57004302
Plain English
Useful advice for those having to prepare plain English summaries of the research they are conducting (NIHR, April 5, 2021).
https://www.nihr.ac.uk/documents/plain-english-summaries/27363
Is your eSystem actually an eCRF?
Some very helpful clarifications in this MHRA Blog from their GCP Inspectorate (MHRA, May 11, 2021).
Unnecessary harm caused by informed consent
The Medical Research Council (MRC) has funded a project to reduce unnecessary harm caused by the way potential trial harms are communicated to potential patients (Cardiff University, May 10, 2021). https://blogs.cardiff.ac.uk/centre-for-trials-research/unnecessary-harm-caused-by-informed-consent/
Paying people to get vaccinated
Serbia has decided to pay people €25 to get the COVID vaccination, but is it a good idea? (The Lancet, May 15, 2021).
Combined Review
Some updated information from the HRA for participants who would like to submit a Clinical Trials of Medicinal Products (CTIMPs) application via the combined review service, formerly known as Combined Ways of Working (CWoW) (HRA, May 17, 2021).
Transparency in PPI
A short article highlighting the importance of transparency from beginning to end of the research process (HRA, May 20, 2021).
https://www.hra.nhs.uk/about-us/news-updates/seeing-research-all-way-through/
What about a third dose of COVID vaccine?
An interesting new study—and a world’s first—is being undertaken in the UK (University of Southampton, May 19, 2021).
https://www.covboost.org.uk/home
First UK COVID vaccine study in pregnancy launched
The phase 2/3 study aims to further understand the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in healthy pregnant women, with approximately 235 volunteers involved throughout the UK (NHS Scotland, May 17, 2021).
What do the public think of research?
A survey commissioned by the NIHR to mark International Clinical Trials Day (NIHR, May 20, 2021).
More COVID Trials needed in Africa
Here the case is made for carrying out more clinical trials in the African continent to test new treatments and vaccines for (The Lancet, May 29, 2021).
And finally...
This is the last clinical research digest I will be posting as my involvement with the NIHR comes to an end. I hope those of you who have been receiving these links over the last eight years have found them useful.
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