Embedded Files
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)
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)
Latest podcasts
The second series of NIHR/HRA podcasts on Innovative Clinical Trials has been launched, and here are the next in the series (Health Research Futures, March 2021).
The second series of NIHR/HRA podcasts on Innovative Clinical Trials has been launched, and here are the next in the series (Health Research Futures, March 2021).
- Thomas Jaki, Universities of Lancaster and Cambridge
The AGILE initiative and the advantages and challenges of Platform Trials - https://soundcloud.com/nihr/prof-jaki
The AGILE initiative and the advantages and challenges of Platform Trials - https://soundcloud.com/nihr/prof-jaki
- Munir Pirmohamed, University of Birmingham
- Matt Sydes, University College London
The importance of communicating trial results to the study participants - https://soundcloud.com/nihr/prof-matt-sydes
The importance of communicating trial results to the study participants - https://soundcloud.com/nihr/prof-matt-sydes
The primary prevention research landscape
A new report led by the MRC provides an important baseline to inform the strategic direction of future prevention research in the UK (UKRI, February 1, 2021). https://www.ukri.org/news/first-analysis-of-primary-prevention-research-landscape-published/
Evaluating COVID-19 vaccines outside of clinical trials
A useful discussion of the ethics of trial design and conduct of COVID vaccines when you have vaccines that work and are being rolled out (JAMA, February 18, 2021). Linked here
Are the statistics of COVID trials understood by the public?
An interesting look at the public perception and understanding of the reported statistics from the vaccine trials (Imperial College London, March 4, 2021). http://wwwf.imperial.ac.uk/blog/perc/2021/03/04/are-the-statistics-from-covid-19-vaccine-trials-understood/
Strategies to improve retention in trials
This systematic review set out to quantify the effect of strategies to improve retention of participants in randomised trials and to investigate if the effect varied by trial setting (Cochrane Library, March 6, 2021). Linked here.
Giving African research participants more say in genomic data
Many human genome studies ask participants to sign a form that gives them little direct control over how their data will be used. But a panel of researchers in Africa says that this can fuel distrust between researchers and participants, and needs to change (Nature, February 15, 2021). Linked here.
UK COVID-19 research passes one million participants
NIHR data shows that a total of 1,075,000 participants have taken part in COVID-19 research, across more than 180 studies. Of these, more than 100 studies were funded by the NIHR, amounting to more than £108 million given to dedicated COVID-19 research (NIHR, March 13, 2021). Linked here.
Involving patients and public in the numbers
This study set out to find out if trialists involve patients and the public in numerical aspects of trials, and how and what are the barriers and facilitators to doing so (BMJ Open, March 18, 2021). https://bmjopen.bmj.com/content/11/3/e046977
New vision for the future of clinical research delivery
Patients, clinicians and researchers across the whole of the UK are set to benefit from the ambitious vision for the future of clinical research delivery, according to this press release from the UK Government (GOV.UK, March 23, 2021). Linked here.
Changes to UK amendment process
Updates information from the Health Research Authority regarding amendments effective March 25, 2021 (HRA, March 24, 2021).
https://content.govdelivery.com/accounts/UKNHSHRA/bulletins/2c93abb
Student research
New eligibility criteria are being introduced by HRA from September 1, 2021 for standalone student research in a health and social care setting (HRA, March 24, 2021). https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/
Precision dosing
This article argues that optimising drug doses for individual patients is an important goal and discusses the implications for drug development and clinical trials (JAMA, March 24, 2021). Linked here.
GCP Inspectors grounded
How the MHRA Inspection programme was affected by the pandemic and lockdown (MHRA, March 26, 2021). Linked here.
Coproduction & Public Involvement—what’s the difference?
A podcast from the Research Design Service looking at this important question (NIHR Research Design Service South East, March 30, 2021).
And finally...
YouTube takes down misleading health information videos
The social media platform reports that it has removed more than 30,000 misleading COVID-19 vaccination videos in the past five months (BBC News, March 12, 2021). https://www.bbc.co.uk/news/technology-56372184
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