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

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The UPTAKE study : implications for the future of COVID-19 vaccination trial recruitment in UK and beyond. / Sethi, Sonika; Kumar, Aditi; Mandal, Anandadeep; Shaikh, Mohammed; Hall, Claire A.; Kirk, Jeremy MW; Moss, Paul; Brookes, Matthew J. ; Basu, Supratik .

In: Trials, Vol. 22, No. 1, 296, 20.04.2021.

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Sethi, Sonika ; Kumar, Aditi ; Mandal, Anandadeep ; Shaikh, Mohammed ; Hall, Claire A. ; Kirk, Jeremy MW ; Moss, Paul ; Brookes, Matthew J. ; Basu, Supratik . / The UPTAKE study : implications for the future of COVID-19 vaccination trial recruitment in UK and beyond. In: Trials. 2021 ; Vol. 22, No. 1.

Bibtex

@article{13a2c49755da4874ae14c5a8836a6ad3,
title = "The UPTAKE study: implications for the future of COVID-19 vaccination trial recruitment in UK and beyond",
abstract = "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.",
keywords = "COVID-19,, Vaccination trials,, Population survey,, BAME,, Vaccine, Pandemics, Cross-Sectional Studies, Humans, Middle Aged, Vaccination, Male, United Kingdom, Clinical Trials as Topic, Patient Selection, Young Adult, Adolescent, Adult, COVID-19/prevention & control, Female, Surveys and Questionnaires, Aged, COVID-19 Vaccines/administration & dosage",
author = "Sonika Sethi and Aditi Kumar and Anandadeep Mandal and Mohammed Shaikh and Hall, {Claire A.} and Kirk, {Jeremy MW} and Paul Moss and Brookes, {Matthew J.} and Supratik Basu",
note = "This is the largest survey study in the UK examining vaccine trial-uptakes. This study has key importance with COVID-19 mutant (VOC) B117 acquiring mutant E484. The study examines the various factors affecting participation in trials, including geographical locations in England. It reports that 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.",
year = "2021",
month = apr,
day = "20",
doi = "10.1186/s13063-021-05250-4",
language = "English",
volume = "22",
journal = "Trials",
issn = "1745-6215",
publisher = "Springer",
number = "1",

}

RIS

TY - JOUR

T1 - The UPTAKE study

T2 - implications for the future of COVID-19 vaccination trial recruitment in UK and beyond

AU - Sethi, Sonika

AU - Kumar, Aditi

AU - Mandal, Anandadeep

AU - Shaikh, Mohammed

AU - Hall, Claire A.

AU - Kirk, Jeremy MW

AU - Moss, Paul

AU - Brookes, Matthew J.

AU - Basu, Supratik

N1 - This is the largest survey study in the UK examining vaccine trial-uptakes. This study has key importance with COVID-19 mutant (VOC) B117 acquiring mutant E484. The study examines the various factors affecting participation in trials, including geographical locations in England. It reports that 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.

PY - 2021/4/20

Y1 - 2021/4/20

N2 - 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.

AB - 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.

KW - COVID-19,

KW - Vaccination trials,

KW - Population survey,

KW - BAME,

KW - Vaccine

KW - Pandemics

KW - Cross-Sectional Studies

KW - Humans

KW - Middle Aged

KW - Vaccination

KW - Male

KW - United Kingdom

KW - Clinical Trials as Topic

KW - Patient Selection

KW - Young Adult

KW - Adolescent

KW - Adult

KW - COVID-19/prevention & control

KW - Female

KW - Surveys and Questionnaires

KW - Aged

KW - COVID-19 Vaccines/administration & dosage

UR - https://link.springer.com/epdf/10.1186/s13063-021-05250-4?sharing_token=yIEnt0jKaqDCUMU_rNuUYW_BpE1tBhCbnbw3BuzI2RPOlhE3S6MgFOzclQegUujZWjvv6WkUS60BdmwZDZRz5bqUZZWw2opbwKC47Rvhb6Q11E5rES9OE3wLQhcIRSW1ky-rrKo7PtYsBsWFOQAauS0I0034JkmpGiqQimfXKDU%3D

U2 - 10.1186/s13063-021-05250-4

DO - 10.1186/s13063-021-05250-4

M3 - Article

C2 - 33879208

VL - 22

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 296

ER -