Abstract
Background/Aims
Coronavirus Disease 2019 (COVID-19) has presented an unprecedented challenge for non-COVID related clinical trials of investigational medicinal medicines (CTIMPs). These challenges are considerable for trials run in high -risk groups, such as older adults. Clinical trials must ensure the safety of their participants, whilst also considering the potential, and often long-term, benefits of the trial intervention to public health. Here we sought to provide a brief perspective on the response and conduct of CTIMPs relevant to older adults and neurology in the UK to the COVID-19 pandemic.
Methods
We performed a cross-sectional study, surveying CTIMP teams running trials broadly relevant to older adults and neurology in the UK, as well as sponsors and Clinical Trials Units (CTU), to understand the response and preparedness to the pandemic.
Results
Due to the pandemic, active recruitment has been suspended in more than half of the trials. The primary driver for the temporary halt of recruitment activity was considerations of patient safety. Interestingly, the majority of trials, sponsors and CTUs did not consider pandemic or epidemic outbreaks in their risk assessments before January 2020.
Conclusion
These findings support the need to re-evaluate the risk-management approach whereby clinical trials establish contingency plans for predicted but rare events to minimise the disruption to recruitment and clinical trial delivery.
Coronavirus Disease 2019 (COVID-19) has presented an unprecedented challenge for non-COVID related clinical trials of investigational medicinal medicines (CTIMPs). These challenges are considerable for trials run in high -risk groups, such as older adults. Clinical trials must ensure the safety of their participants, whilst also considering the potential, and often long-term, benefits of the trial intervention to public health. Here we sought to provide a brief perspective on the response and conduct of CTIMPs relevant to older adults and neurology in the UK to the COVID-19 pandemic.
Methods
We performed a cross-sectional study, surveying CTIMP teams running trials broadly relevant to older adults and neurology in the UK, as well as sponsors and Clinical Trials Units (CTU), to understand the response and preparedness to the pandemic.
Results
Due to the pandemic, active recruitment has been suspended in more than half of the trials. The primary driver for the temporary halt of recruitment activity was considerations of patient safety. Interestingly, the majority of trials, sponsors and CTUs did not consider pandemic or epidemic outbreaks in their risk assessments before January 2020.
Conclusion
These findings support the need to re-evaluate the risk-management approach whereby clinical trials establish contingency plans for predicted but rare events to minimise the disruption to recruitment and clinical trial delivery.
| Original language | English |
|---|---|
| Article number | e10613 |
| Number of pages | 9 |
| Journal | Cureus |
| Volume | 12 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - 23 Sept 2020 |
Research Groups and Themes
- Covid19
- Ageing and Movement Research Group
Keywords
- CTIMPs
- Clinical trials
- COVID-19
- UK
- Governance
- methods
- Risk Assessment
Access to Document
- Full-text PDF (final published version)
This is the final published version of the article (version of record). It first appeared online via Cureus at dx.doi.org/10.7759/cureus.10613. Please refer to any applicable terms of use of the publisher.