1、Diversity and clinical trials Diversity and clinical trials in the UKin the UKFebruary 2024Clinical trials have a diversity blind spotClinical trials are critical to the development of medicines and devices to improve the health and wellbeing of people around the world.However,trials have historical

2、ly failed to engage a diverse group of participants from different ethnic and racial backgrounds.Creating more supportive environments for a diverse range of individuals to participate in clinical trials is a critical step in achieving health equity.Getting a clear view of how people currently think

3、 about clinical trials can help us identify what steps need to be taken to make this a reality.We conducted research to understand differences between white and ethnic minority adults in the UK when it comes toAwareness,knowledge and perception of clinical trials Clinical trial participation Key bar

4、riers and motivators to participation 123TARGETGeneral Public Age 16+based in the UKSAMPLE SIZEN=8,206 HEALTH HISTORY59.6%had any medical condition*GENDERMale 48%Female:52%RACE/ETHNICITY*White:88%/Asian:8%Black/African/Caribbean:2%Other Ethnicity:2%*Primarily,Mental health 19%,Arthritis 13%,Asthma 1

5、2%,Hypertension 12%*White;including White minorities*n=39 did not use internet,primarily White(n=32),in England(n=33),55+(n=36)We conducted a survey among a nationally representative sample of over 8,000 adults in the UK,12%of whom were ethnic minoritiesINTERNET ACCESS99%had access to internet*METHO

6、DOLOGY8-min nationally representative survey run by Ipsos KnowledgePanel between 14-20 September 202341%of Ethnic Minority respondents*Base:All respondents(n=8206)QA6:How willing or not would you be to participate in a clinical trial in the future?You can answer this question whether or not you have

7、 participated in a clinical trial before.58%are willing to participate in a clinical trial61%of White respondents21%are unwilling to participate in a clinical trial19%of White respondents33%of Ethnic Minority respondents*Willingness to participate in clinical trials is significantly lower among adul

8、ts from ethnic minority backgrounds*significantly lower*significantly higherhave been invited to participate in a trial before14%of White respondents18%of Ethnic Minority respondents*Of those invited have participated in a trial46%of White respondents36%of Ethnic Minority respondents*Base:All respon

9、dents(n=8206),all invited to a trial(n=1189)QA4:Have you ever been asked or invited to join a clinical trial to test a new drug,medical device,or surgical procedure by a healthcare provider?QA5:Have you ever participated in a clinical trial to test a new drug,medical device,or surgical procedure bef

10、ore?Similarly,although they are more likely to be invited,significantly fewer ethnic minority adults will take part in a clinical trial*significantly higher*significantly lower14%44%Whats behind the gap between willingness and participation?94%of White respondents have heard the term clinical trial

11、before91%have heard the term clinical trial before77%of Ethnic Minority respondents have heard the term clinical trial before*Base:All respondents(n=8206)QA2:Have you ever heard the term clinical trial before?Knowledge may be a factor:9 in 10 have heard of clinical trials,but this is significantly l

12、ower among ethnic minority adults*significantly lowerLowest awareness among Black/African/Caribbean women(70%)Lower awareness among ethnic minorities in urban areas30%36%27%*21%9 9 1 in 4 ethnic minority adults feel they do not know enough about research or clinical trials to participate*Significant

13、ly higher than White adultsBase:all respondents(n=8206).QB2:Which of the following reasons,if any,would make it difficult for you to participate in a clinical trial?You can answer this regardless of whether you have participated in a clinical trial before.White adultsEthnic minority adultsFor men,hi

14、ghest among Black/African/CaribbeanFor women,highest among Asian and Black/African/CaribbeanAge also plays an important role in knowledge across groupsKnowledge among Black/African/Caribbean adults is consistently lower among adults between 16-44 compared to 45-54 year-oldsKnowledge among Black/Afri

15、can/Caribbean,Asian,and Other ethnic minority groups is lowest among 65-74 year-olds1010 Fear and mistrust also appear to play a large role in preventing ethnic minority adults in the UK from participating in clinical trialsFear of risks and side effectsLack of trust in the healthcare system Lack of

16、 trust in pharmaDiscomfort with research 1111 Base:All respondents(n=8206)QB2:Which of the following reasons,if any,would make it difficult for you to participate in a clinical trial?You can answer this regardless of whether you have participated in a clinical trial before.While fear of side effects

17、 and risk of participation is the largest barrier to participation,it is significantly higher among ethnic minority adults*Significantly higher than White adultsWhite adultsEthnic minority adultsHighest among Black/African/Caribbeans aged 35-44Highest among Asians aged 65-7468%58%*50%72%I&D Research

18、 2022 Plan|IUONearly 1 in 4 ethnic minority adults do not trust pharmaceutical companies to test treatments and devices on them1212 Base:All respondents(n=8206)QB2:Which of the following reasons,if any,would make it difficult for you to participate in a clinical trial?You can answer this regardless

19、of whether you have participated in a clinical trial before.*Significantly higher than White adultsWhite adultsEthnic minority adultsHighest among Black/African/Caribbean adults23%*13%29%19%17%1313 I do not feel comfortable spending time in hospitals or health care settingsI do not feel that staff w

20、ill listen to me if I have problemsBase:All respondents(n=8206)QB2:Which of the following reasons,if any,would make it difficult for you to participate in a clinical trial?You can answer this regardless of whether you have participated in a clinical trial before.Ethnic minority adults were significa

21、ntly more likely to report lack of trust in the health system as a barrier to participation*Significantly higher than White adultsWhite adultsWhite adultsEthnic minority adultsEthnic minority adultsHighest among Black/African/Caribbean womenHighest among Black/African/Caribbean women10%6%15%*11%*23%

22、30%1414 Base:All respondents(n=8206)QB2:Which of the following reasons,if any,would make it difficult for you to participate in a clinical trial?You can answer this regardless of whether you have participated in a clinical trial before.Ethnic minority adults were also significantly more likely to re

23、port discomfort or lack of trust in clinical trials and research as barriers to participation I do not feel comfortable being studiedI have heard of clinical trials that have been conducted unjustly in the pastHighest among Black/African/Caribbean women White adultsWhite adultsEthnic minority adults

24、Ethnic minority adults*Significantly higher than White adultsHighest among Asian men and Black/African/Caribbean women 8%10%23%*19%*1515 Location and cost of participation in a trial are also a barrier for some47%overall would find the location of the clinical trial to be a barrier28%overall are con

25、cerned about cost of participationBase:All respondents(n=8206)QB2:Which of the following reasons,if any,would make it difficult for you to participate in a clinical trial?You can answer this regardless of whether you have participated in a clinical trial before.Highest for white adults overall(49%)S

26、ignificantly high for Asian adults aged 65-74 In England,significantly high for adults in rural areasHigher income respondents across all ethnicities are more concerned about locationLess concern for younger adultsNo notable difference by ethnicity and ageNo notable difference by ethnicity and incom

27、eHighest for Asian men(32%)compared to their female counterparts(20%)I&D Research 2022 Plan|IUO1616 How can we increase diverse clinical trial participation in the UK?I&D Research 2022 Plan|IUO1717 The potential of clinical trials to improve ones own health and the health ofothers were the two great

28、est motivators across all respondentsEmphasising the benefit of clinical trials on both a personal and community level should be included in communications and messagingBase:All respondents(n=8206).QB1:Which of the following reasons,if any,would motivate you to participate in a clinical trial?You ca

29、n answer this regardless of whether you have participated in a clinical trial before.Ensuring payment for travel or missed work was significantly more important in motivating clinical trial participation for ethnic minority adults in the UK,across income levelsClear communication about logistics of

30、clinical trials,and remuneration and support for participants is vitally important(e.g.,when and how participants will be paid)1818 Base:All respondents(n=8206).QB1:Which of the following reasons,if any,would motivate you to participate in a clinical trial?You can answer this regardless of whether y

31、ou have participated in a clinical trial before.Communication channels should be tailored by age 1919 Base:All respondents(n=8206)QB4.There are many possible ways that people can learn about clinical trials.Please select up to three of your preferred methods of communication.Black/African/Caribbean

32、young adults aged 16-24 and 55+would also like group education sessions;these could be held in healthcare settings or community spacesWebsites and email from HCPs are preferred methods of communication about trials for ethnic minority adults between 16-34Face-to-face discussions with an HCP is the m

33、ost preferred communication method for ethnic minority adults by all ages,particularly for those age 35+Ethnic minority adults 25+also like receiving leaflets and brochures,which can be easily handed out in an HCPs office and link to other resources like a websiteLeveraging referring physicians as t

34、rusted sources of information may be key to overcoming emotional barriers2020 Make explicit what the trade-offs and benefits of participation areReframe risk in a simple way(e.g.,1 in 100 experience headache)Emphasise that ensuring their safety in the trial will be a key priority Explain study proce

35、sses clearly in jargon-free language to reduce uncertainty and fearPosition participation as contributing to the greater goodShow examples of others from the community who participated in clinical trials Approach conversations with empathy to address anxiety,fear,stressExplain processes for monitori

36、ng and providing regular feedback throughout trialsProvide connections to support groups or peer mentors What if I get side effects from the trial?The thought of being studied makes me uncomfortableDoctors have minimised my complaints before when Ive been sickSharing real-life patient experiences ca

37、n help demystify clinical trial participation and make it seem more accessible 2121 Base:All respondents(n=8206).QB1:Which of the following reasons,if any,would motivate you to participate in a clinical trial?You can answer this regardless of whether you have participated in a clinical trial before.

38、1 in 4 Black/African/Caribbean adults would find being able to speak with someone else about their experience in a trial to be motivating,significantly higher than any other groupProvide opportunities for past participants to share testimonials,including forums or Q&A sessions Engage peer educators/

39、advocates who can provide 1-1 support to potential participants 2222 Promote transparency and allow for participants broader support systems to be involved throughout the process Allow for a family member or friend to be involved from early discussions to the decision-making processUse patient navig

40、ators to help understand process such as help with transport and lodging,and provide ongoing emotional supportKeep referring physicians engaged and updated throughout the trial if the patient desiresIncreasing engagement will have a reciprocal effect on trust2323 Base:All respondents(n=8206)QB3:Belo

41、w is a list of statements about diversity and clinical trials.Please consider whether you agree or disagree with these statements.7 in 10 adults in the UK across ethnicities agree that encouraging more diverse clinical trial participation can increase trust in the healthcare and pharmaceutical indus

42、triesTo combat perceptions of historical injustice,clinical trials should be designed using a community-informed approach,with transparent and routine feedback mechanismsCharting the course to health equity togetherAlthough patient-centred clinical trial design is now a growing practice,our study sh

43、ows that efforts to recruit diverse participants can be still be greatly improved.Conducting research to give voice to future clinical trial participants is an important part of determining what changes need to be made,but it is only a piece of the puzzle.It is up to the research,healthcare,and life

44、 sciences industries to work together to design more innovative and inclusive strategies for clinical trial engagement in the future.Rebecca WestRebecca.WTHANK THANK YOUYOUAppendixAppendix2626 Technical noteRecruitment to the panelPanellists are recruited via a random probability un-clustered addres

45、s-based sampling method.This means that every household in the UK has a known chance of being selected to join the panel.Letters are sent to selected addresses in the UK(using the Postcode Address File)inviting them to become members of the panel.Invited members can sign up to the panel by completin

46、g a short online questionnaire or returning a paper form.Up to 2 members of the household can sign up to the panel.Members of the panel who are digitally excluded can register either by post or telephone,and are given a tablet,an email address and basic internet access which allows them to complete

47、surveys online.Completing the surveyThe survey was designed using a mobile-first approach,which took into consideration the look,feel and usability of a questionnaire on a mobile device.This included a thorough review of the questionnaire length to ensure it would not over-burden respondents from fo

48、cusing on a small screen for a lengthy period,avoiding the use of grid-style questions(instead using question loops which are more mobile friendly)and making questions finger-friendly so theyre easy to respond to.The questionnaire was also compatible with screen reader software to help those requiri

49、ng further accessibility.SampleThis study was conducted on the KnowledgePanel between 14th 20th September 2023.The KnowledgePanel is a random probability survey panel.Therefore,the KnowledgePanel does not use a quota approach when conducting surveys.Instead invited samples are stratified when conduc

50、ting waves to account for any profile skews within the panel.The sample was stratified by country and education.A total of 16,138 panellists in the UK(16+)were selected and invited to take part in the survey.Of these,8,206 respondents completed the survey.WeightingTo ensure the survey results are as

51、 representative of the population as possible,the below weighting spec was applied to the data in line with the target population profile.Up to 3 people per household were allowed to complete this survey.To account for this and varying household sizes,we employed a design weight to correct for unequ

52、al probabilities of selection of household members.Calibration weights have also been applied using the latest population statistics relevant to the surveyed population to correct for imbalances in the achieved sample.England and Wales,Scotland,and Northern Ireland were each weighted separately,whil

53、e an additional weight has been created for the United Kingdom to account for any over or under-sampling within each of these countries.Calibration weights were applied in two stages:1.The first set of variables(using ONS 2019 mid-year population estimates as the weighting targets):An interlocked va

54、riable of gender by age,and region.2.The second set were(using ONS 2019 mid-year population estimates and the ONS Annual Population Survey as the weighting targets):education,ethnicity,index of multiple deprivation(quintiles),and number of adults in the household.Ethnicity and number of adults in th

55、e household were not applied to Northern Ireland.Weighting profile:England and WalesAge and GenderMaleFemaleIn another wayPNTS16-246.7%6.3%0.1%0.1%25-348.3%8.2%0.1%0.0%35-447.7%7.8%0.1%0.1%45-548.2%8.4%0.0%0.0%55-647.3%7.5%0.0%0.1%65-745.9%6.4%0.0%0.1%75+4.5%6.0%0.0%0.0%RegionNorth East4.6%North Wes

56、t12.4%Yorkshire and The Humber9.3%East Midlands8.2%West Midlands9.9%East of England10.5%London14.8%South East15.4%South West9.6%Wales5.4%IMD Quintiles120.0%220.0%320.0%420.0%520.0%EducationDegree level or above30.0%Below degree level68.9%Prefer not to say/Not stated1.2%EthnicityWhite85.7%Non-white13

57、.0%Dont know/prefer not to say1.3%Number of adults in householdOne18.2%Two or more81.8%Weighting Profile:ScotlandAge and GenderMaleFemaleIn another wayPNTS16-2414.6%14.5%0.2%0.1%25-347.2%7.5%0.1%0.0%35-448.1%8.6%0.0%0.2%45-547.8%8.3%0.0%0.0%55-646.1%6.6%0.0%0.0%65-744.2%6.0%0.0%0.0%75+14.6%14.5%0.2%

58、0.1%RegionCentral Scotland12.1%Glasgow13.1%Highlands and Islands8.3%Lothian14.6%Mid Scotland and Fife12.3%North East Scotland14.1%South Scotland12.6%West Scotland12.9%IMD Quintiles120.0%220.0%320.0%420.0%520.0%EducationDegree level or above27.5%Below degree level70.5%Prefer not to say/Not stated2.0%

59、EthnicityWhite94.5%Non-white4.7%Dont know/prefer not to say0.8%Number of adults in householdOne21.7%Two or more78.3%Weighting Profile:Northern IrelandAge and GenderMaleFemaleIn another wayPNTS16-4423.1%23.1%0.3%0.0%45-548.4%8.8%0.0%0.0%55-647.6%7.8%0.0%0.0%65+9.5%11.4%0.0%0.0%RegionBelfast15.5%East24.5%North15.7%Outer Belfast21.8%West and South22.5%IMD Quintiles120.0%220.0%319.9%420.0%520.1%EducationDegree level or above27.5%Below degree level70.5%Prefer not to say/Not stated2.0%