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

Sonika Sethi; Aditi Kumar; Anandadeep Mandal; Mohammed Shaikh; Claire A. Hall; Jeremy MW Kirk; Paul Moss; Matthew J.  Brookes; Supratik  Basu

doi:10.1186/s13063-021-05250-4

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

Sonika Sethi, Aditi Kumar, Anandadeep Mandal, Mohammed Shaikh, Claire A. Hall, Jeremy MW Kirk, Paul Moss, Matthew J. Brookes, Supratik Basu

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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.

Original language	English
Article number	296
Number of pages	12
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05250-4
Publication status	Published - 20 Apr 2021

Bibliographical 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.

Keywords

Adolescent
Adult
Aged
BAME,
COVID-19 Vaccines/administration & dosage
COVID-19,
COVID-19/prevention & control
Clinical Trials as Topic
Cross-Sectional Studies
Female
Humans
Male
Middle Aged
Pandemics
Patient Selection
Population survey,
Surveys and Questionnaires
United Kingdom
Vaccination
Vaccination trials,
Vaccine
Young Adult

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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SethiS2021UPTAKEFinal published version, 477 KBLicence: Creative Commons: Attribution (CC BY)

Cite this

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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.",

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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",

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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 - Adolescent

KW - Adult

KW - Aged

KW - BAME,

KW - COVID-19 Vaccines/administration & dosage

KW - COVID-19,

KW - COVID-19/prevention & control

KW - Clinical Trials as Topic

KW - Cross-Sectional Studies

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Pandemics

KW - Patient Selection

KW - Population survey,

KW - Surveys and Questionnaires

KW - United Kingdom

KW - Vaccination

KW - Vaccination trials,

KW - Vaccine

KW - Young Adult

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JO - Trials

JF - Trials

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M1 - 296

ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

Access to Document

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Cite this