The UPTAKE study: implications for the future of COVID-19 vaccination trial recruitment in UK and beyond.

Autor: Sethi S; The Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton Road, Wolverhampton, West Midlands, WV10 0QP, UK. sonika.sethi1@nhs.net., Kumar A; The Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton Road, Wolverhampton, West Midlands, WV10 0QP, UK., Mandal A; University of Birmingham, Birmingham, UK., Shaikh M; National Institute for Health Research, Clinical Research Network, Coventry, West Midlands, UK., Hall CA; National Institute for Health Research, Clinical Research Network, Coventry, West Midlands, UK., Kirk JMW; National Institute for Health Research, Clinical Research Network, Coventry, West Midlands, UK.; Research Institute in Healthcare Sciences (RIHS), University of Wolverhampton, Wolverhampton, UK., Moss P; University of Birmingham, Birmingham, UK., Brookes MJ; The Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton Road, Wolverhampton, West Midlands, WV10 0QP, UK.; National Institute for Health Research, Clinical Research Network, Coventry, West Midlands, UK.; Research Institute in Healthcare Sciences (RIHS), University of Wolverhampton, Wolverhampton, UK., Basu S; The Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton Road, Wolverhampton, West Midlands, WV10 0QP, UK.; National Institute for Health Research, Clinical Research Network, Coventry, West Midlands, UK.; Research Institute in Healthcare Sciences (RIHS), University of Wolverhampton, Wolverhampton, UK.
Jazyk: angličtina
Zdroj: Trials [Trials] 2021 Apr 20; Vol. 22 (1), pp. 296. Date of Electronic Publication: 2021 Apr 20.
DOI: 10.1186/s13063-021-05250-4
Abstrakt: Background: Developing a safe and effective vaccine will be the principal way of controlling the COVID-19 pandemic. However, current COVID-19 vaccination trials are not adequately representing a diverse participant population in terms of age, ethnicity and comorbidities. Achieving the representative recruitment targets that are adequately powered to the study remains one of the greatest challenges in clinical trial management. To ensure accuracy and generalisability of the safety and efficacy conclusions generated by clinical trials, it is crucial to recruit patient cohorts as representative as possible of the future target population. Missing these targets can lead to reduced validity of the study results and can often slow down drug development leading to costly delays.
Objective: This study explores the key factors related to perceptions and participation in vaccination trials.
Methods: This study involved an anonymous cross-sectional online survey circulated across the UK. Statistical analysis was done in six phases. Multi-nominal logistic models examined demographic and geographic factors that may impact vaccine uptake.
Results: The survey had 4884 participants of which 9.44% were Black Asian Minority Ethnic (BAME). Overall, 2020 (41.4%) respondents were interested in participating in vaccine trials; 27.6% of the respondents were not interested and 31.1% were unsure. The most interested groups were male (OR = 1.29), graduates (OR = 1.28), the 40-49 and 50-59 age groups (OR = 1.88 and OR = 1.46 respectively) and those with no health issues (OR = 1.06). The least interested groups were BAME (OR = 0.43), those from villages and small towns (OR = 0.66 and 0.54 respectively) and those aged 70 and above (OR = 1.11).
Conclusions: In order to have a vaccination that is generalisable to the entire population, greater work needs to be done in engaging a diverse cohort of participants. Public health campaigns need to be targeted in improving trial recruitment rates for the elderly, BAME community and the less educated rural population.
Databáze: MEDLINE
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