COVID19: Adapting to Challenges in Delivering Research Posed by the Global Pandemic
BAUS ePoster online library. Bass E. 06/22/21; 319130; p9-2
Disclosure(s): HUA's research is supported by core funding from the United Kingdom’s National Institute of Health Research (NIHR) Imperial Biomedical Research Centre. HUA currently receives funding from the Wellcome Trust, Medical Research Council (UK), Cancer Research UK, Prostate Cancer UK, The Urology Foundation, BMA Foundation, Imperial Health Charity, NIHR Imperial BRC, Sonacare Inc., Trod Medical and Sophiris Biocorp for trials in prostate cancer. HUA was a paid medical consultant for Sophiris Biocorp in the previous 3 years.
Mr. Edward Bass
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Abstract
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Introduction:
The global COVID19 pandemic presents unique circumstances, in which delivering clinical research is clearly more challenging than usual. In efforts to keep patients away from hospitals, telephone or virtual clinics quickly became standard. Many patients themselves preferred to eschew journeys to hospital, avoiding untoward infection risk. Hospital research staff were redeployed en masse to aid regional COVID19 efforts. It was clear that rapid development of remote research processes such as recruitment; consent and data collection would be needed to facilitate continuation of clinical trials.
Methods:
Our trials group developed a comprehensive electronic clinical trials platform, using the RedCap database software package. The design incorporated multiple features. First, remote access to the trial participant information sheet accompanied by an explanatory information video. Second, an electronic consent system. Third, electronic collection of patient related outcome measure (PROM) questionnaires, automated for each visit. The platform was reviewed by trial stakeholders, including patient representatives investigators and other site staff through the trial management group.
Results:
After review of each of the platform features by the trial stakeholders, the initial site adopted the platform. Three further sites opened to recruitment during the pandemic due in part to the efficiency of the platform.
Conclusions:
The adoption of the electronic trial platform by participating sites demonstrates its acceptability. Further research is required to demonstrate the efficacy of the platform features, as measured by participant engagement with each process, and their feedback.
The global COVID19 pandemic presents unique circumstances, in which delivering clinical research is clearly more challenging than usual. In efforts to keep patients away from hospitals, telephone or virtual clinics quickly became standard. Many patients themselves preferred to eschew journeys to hospital, avoiding untoward infection risk. Hospital research staff were redeployed en masse to aid regional COVID19 efforts. It was clear that rapid development of remote research processes such as recruitment; consent and data collection would be needed to facilitate continuation of clinical trials.
Methods:
Our trials group developed a comprehensive electronic clinical trials platform, using the RedCap database software package. The design incorporated multiple features. First, remote access to the trial participant information sheet accompanied by an explanatory information video. Second, an electronic consent system. Third, electronic collection of patient related outcome measure (PROM) questionnaires, automated for each visit. The platform was reviewed by trial stakeholders, including patient representatives investigators and other site staff through the trial management group.
Results:
After review of each of the platform features by the trial stakeholders, the initial site adopted the platform. Three further sites opened to recruitment during the pandemic due in part to the efficiency of the platform.
Conclusions:
The adoption of the electronic trial platform by participating sites demonstrates its acceptability. Further research is required to demonstrate the efficacy of the platform features, as measured by participant engagement with each process, and their feedback.
Introduction:
The global COVID19 pandemic presents unique circumstances, in which delivering clinical research is clearly more challenging than usual. In efforts to keep patients away from hospitals, telephone or virtual clinics quickly became standard. Many patients themselves preferred to eschew journeys to hospital, avoiding untoward infection risk. Hospital research staff were redeployed en masse to aid regional COVID19 efforts. It was clear that rapid development of remote research processes such as recruitment; consent and data collection would be needed to facilitate continuation of clinical trials.
Methods:
Our trials group developed a comprehensive electronic clinical trials platform, using the RedCap database software package. The design incorporated multiple features. First, remote access to the trial participant information sheet accompanied by an explanatory information video. Second, an electronic consent system. Third, electronic collection of patient related outcome measure (PROM) questionnaires, automated for each visit. The platform was reviewed by trial stakeholders, including patient representatives investigators and other site staff through the trial management group.
Results:
After review of each of the platform features by the trial stakeholders, the initial site adopted the platform. Three further sites opened to recruitment during the pandemic due in part to the efficiency of the platform.
Conclusions:
The adoption of the electronic trial platform by participating sites demonstrates its acceptability. Further research is required to demonstrate the efficacy of the platform features, as measured by participant engagement with each process, and their feedback.
The global COVID19 pandemic presents unique circumstances, in which delivering clinical research is clearly more challenging than usual. In efforts to keep patients away from hospitals, telephone or virtual clinics quickly became standard. Many patients themselves preferred to eschew journeys to hospital, avoiding untoward infection risk. Hospital research staff were redeployed en masse to aid regional COVID19 efforts. It was clear that rapid development of remote research processes such as recruitment; consent and data collection would be needed to facilitate continuation of clinical trials.
Methods:
Our trials group developed a comprehensive electronic clinical trials platform, using the RedCap database software package. The design incorporated multiple features. First, remote access to the trial participant information sheet accompanied by an explanatory information video. Second, an electronic consent system. Third, electronic collection of patient related outcome measure (PROM) questionnaires, automated for each visit. The platform was reviewed by trial stakeholders, including patient representatives investigators and other site staff through the trial management group.
Results:
After review of each of the platform features by the trial stakeholders, the initial site adopted the platform. Three further sites opened to recruitment during the pandemic due in part to the efficiency of the platform.
Conclusions:
The adoption of the electronic trial platform by participating sites demonstrates its acceptability. Further research is required to demonstrate the efficacy of the platform features, as measured by participant engagement with each process, and their feedback.
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