Divergent views on drivers of early phase clinical trial participation among ethnically diverse potential trial participants in the United Kingdom: A Mixed Methods Study

BackgroundNovel therapeutics should always be tested in a sample representative of the population in need of treatment. Initial efforts of drug development take place in early phase trials (phase-I and -II), setting the direction for late-stage studies (phase-III and -IV). However, study samples in early phase trials typically fail to recruit Black, Asian and minority ethnic groups, which might produce results which dont generalise to a broader population in later trials, and ultimately, clinical practice. Focusing on early phase clinical trials the present study (1) explored the barriers and incentives that determine participation of ethnic minorities in clinical research, and (2) proposes strategies that mitigate such barriers. MethodsA systematic literature review explored barriers affecting participation rates from individuals from diverse ethnic backgrounds. An exploratory phase involved two online surveys (researchers and general population) and focus groups (general population) analysed using thematic analysis. ResultsThe systematic review found little published evidence, with most studies undertaken in the USA and focused on specific clinical areas. The exploratory phase showed a discordance between researchers and general publics perspectives on both drivers and barriers to early phase trial participation. DiscussionThese findings were synthesised into a Clinical Trials Participatory Framework, which contextualises reasons for reduced trial participation, while providing mechanisms/strategies to increase uptake among minority ethnic participants. This may guide researchers when implementing strategies to aid under-representation in their samples. Further research should evaluate the framework by actively implementing, testing, and iterating upon the strategies.