Developing a safe and effective vaccine is being and will be the principal way of controlling the COVID-19 pandemic. With currently more than 1,200 variant lineages of the COVID-19 coronavirus identified in the world, ongoing vaccine trials remain essential. However, there are growing concerns regarding adequate representation of COVID-19 vaccination trials amongst 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 generalizability 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. Only approximately 50% of vaccine clinical trials in the UK achieve their recruitment target, resulting in approximately one third of trial terminations. Missing these targets can lead to reduced validity of the study results and can often slow down drug development, leading to costly delays.
In the study published in the journal ‘Trials’ in April 2021, we conduct UK largest cross-sectional examination to explore the key factors related to perceptions and participation in vaccination trials. The study explored the demographics of those who are less likely to take part in trials in helping to target strategies in recruiting patients for ongoing challenge trials. The study was conducted in collaboration with NHS Trust and National Institute of Health Research, UK. A total of 4884 respondents completed the survey. The majority were females (69·9%) and of White ethnicity (84·5%). There were BAME respondents (9·44%), amongst which 5.30 % were Asian/Asian British-Indian and only 1.38% were Black/African/Caribbean/Black British. Most of the respondents were qualified up to at least A-level (32·2%), with 36·4% university undergraduate degree holders and 20·7% post-graduate respondents. The age group between 50-59 years were the largest participant age group (22·5%), with 11·3% responses from those aged 70 and above. 39·9% of the respondents stated diagnosed health issues.
Overall, 41.40% respondents were interested in participating in vaccine trials. 27.6% of the respondents were not interested in vaccine trials and 31.1% were unsure. We show that maximum participation was from ‘other cities’ (29.07%) followed by ‘small town’ (22%). This is the first study to identify that ‘other cities’, smaller cities, such as Leicester and Aberdeen are more likely to participate in trials compared to larger metropolitan ‘core cities’, such as London and Birmingham. A reason for this could be attributed to ‘core cities’ having greater pockets of inner-city poverty and health inequalities, compared to ‘outer cities’. Of those respondents not interested in participating in vaccine trials, the majority were from ‘villages’ (31.95%). Further, it is interesting to note that while the maximum number of male respondents interested in trials were from ‘medium town’ (35.6%), the majority of the interested females were from ‘other city’ (37.5%). Whilst the majority of the graduates and postgraduates who were interested in trials were from ‘other city’, a significant number of non-university goers who were interested in trials were from ‘medium town’. In respondents aged 50 and less who were interested in vaccine trials lived in ‘other city” whilst those aged 60 and over that were interested in trials came from ‘medium town’.
Of those who choose not to participate in vaccine trials, 15.22% indicated that they have previously declined vaccinations and 7.75% were smokers. Amongst the non-participants, females accounted for 73.25%. Concerning the age-groups, maximum number of non-participants were from 50-59 (21.72 %). Interestingly, while only 2.25% of the respondents with no formal qualification were non-participants, 36.5 % of the graduates refused to uptake vaccine trials.
The BAME community are less likely to get involved in the COVID-19 vaccination trials, despite them being at higher risk of COVID-19. The UK COVID-19 vaccine registry also demonstrates that BAME groups are short of reaching national targets representing less than 8% of the registry despite representing 13% of the population. The under-representation of the Black community, is likely to be attributed to mistrust in the medical profession, as well as historical oppression and health inequalities.
Our findings suggest that mistrust is a key factor in non-uptake for vaccination trials. Free text comments from the survey revolved around the idea of the BAME community being used for trials to verify vaccine results, and mistrust around government strategies. Similar sentiments have been found in US studies. This was likely to have taken influence from social media views at the time of survey completion, particularly those highlighting adverse events from vaccine trials and vaccines trials being rushed.
The challenges with recruitment for trials are set to increase, as phase 3 vaccine trials continue to take place from 2021. Barriers will become more pronounced when recruiting to placebo phase three trials and further non-inferiority studies, where vaccines will go head-to-head. Thus, there is a need to consider the redesign and reshaping of these studies to consider these barriers and engage the patients in the recruitment plan for these newly designed studies.
The research was conducted and co-authored by Sethi, Sonika, Aditi Kumar, Anandadeep Mandal, Mohammed Shaikh, Claire A. Hall, Jeremy MW Kirk, Paul Moss, Matthew J. Brookes, and Supratik Basu. "The UPTAKE study: implications for the future of COVID-19 vaccination trial recruitment in UK and beyond." Trials 22, no. 1 (2021): 1-12