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

Background: Novel 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 don't 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. Methods: A 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. Results: The 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 public's perspectives on both drivers and barriers to early phase trial participation. Discussion: These 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. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: North Star Review Board, nonprofit IRB. Determined to not require ethical review, likely would have been exempt if under jurisdiction of the Common Rule I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present work are contained in the manuscript