Table 4 Research stage and themes

 Barriers

View that potential ethnic group participants are not engaged with research

“I can walk out into the clinic and you can pretty much pick out who will not contribute. And it’s not that they do not want to contribute, it’s that quite a lot of the time it’s because they do not expect anyone to want them to or do not think they can add much value.” [043]

Ineffective efforts to recruit ethnic minority participants

“We’ve always fully intended to engage with different ethnic minority groups and gone to lengths to see if we can have measures translated or interpreters available but, in honesty, the vast majority of participants that we have had have been white British and it’s not been intentional. We’ve done our work in very mixed multicultural areas ... So we have not had to deal with that, which is odd and I feel we should have done. I do not know what happens to those people. And they have not been there to recruit.” [021]

Limited motivation from trialists

“What we are not doing as an industry is recognising that if we go to a minority ethnic group and say, help us do this because we need questions which are relevant to patients from your background, they love doing it and they’ll happily help. But generally speaking we do not do it, we assume the patient is the patient so, you know, the white, middle class, well educated person who’s involved gets asked the questions and then everyone wonders why you do not get the same kind of answers from the Afro-Caribbean men or the Asian Sub-Continent women.” [027]

Limited capacity of researchers

“We did not do anything that was specifically aimed at minority groups to increase recruitment. Our study was pretty challenging … So just getting it off the ground … took all of our time and we did not have any bandwidth to, and nor do I think it crossed our minds a lot either, which it should have but we just did not have any bandwidth.” [017]

Researchers’ limited experience

“No I’m aware of the fact that it’s not well done and I’m aware of the fact, some people are trying to stress those issues, and I think it’s really important, it’s just not something I’ve got involved with.” [013]

Fatalistic view of recruiting ethnic minority participants

“We have to accept that minority groups are not as engaged in participating in research studies as other groups are.” [007]

 Facilitators

Understanding views and experiences of minority groups

“There are very different views in some of our cultural groups that we have to respect and we have to understand them to then understand what we could do with patients at risk and what might be important and what might matter to them.” [033]

Connecting with community leaders

“You can recruit in areas where you have ethnic minority participants and develop some engagement strategies with community leaders.” [028]

Working with peer-researchers

“They had some funding … to do some research with the non-English speaking Chinese community. And they recruited several non-English speaking Chinese … and through interpreters worked with them and developed a structure for the study. But then those same non-English speaking Chinese actually worked as the researchers on the study, they actually did the field work, with support and supervision obviously, but they actually did the field work. And the results that came back as far as the academic team were concerned were quite unexpected and were not typical of what they were expecting having done similar studies with other groups of people.” [027]

Recognition that ethnic minority populations are motivated to take part in responsible research

“But they want research done … they just want people to say what they are collecting and why and use it responsibly and that sort of thing. I do not think it has really held up much, there’s a lot of good research that is wanted.” [008]

 Barriers

Use of international studies to identify ethnic differences

“If you have got very different ethnic groups … the sub-section might be so small you cannot draw any valid results from it and you can get different physiological responses from different ethnic group. For instance, if you want to know how a drug works in Chinese people, you might actually be better to do that in China, rather than trying to allow for a small sample of ten in a much larger trial … For drug companies … If they are going to launch something globally, they will be testing it in China, Japan, Europe and India and they will do different trials in each country. So, the fact that you do not necessarily test the drug in a lot of Asian speaking people in the UK, in a way, is neither here nor there, if they are going to do large trials in India.” [041]

Perceived relevance of ethnicity and PROs to oncology

“I think there is a little bit less concern in oncology with the demographic make-up of our sample. When you look at other therapeutic areas … PROs are more prominent and more influenced by demographic factors” [010]

Inconsistent views on relevance of ethnicity to research question

“I think partly because [cancer type] is mainly in the Caucasian population and not that many people - but in [large multicultural city], for example, there are a significant number of people from the BME (Black and Minority Ethnic) communities who do have [this kind of cancer]...” [017]

Prominence of PRO to study

“I think there is a general concern with making sure that we have a very good representative sample, but it’s not specific to PROs.” [010]

Limited detail in study protocol

“It’s not typically something that really is talked about in the protocol, we will use a validated linguistic and cultural adaptation of each instrument but there is not any language in the protocols usually about any differences in how the instruments are administered or anything like that … It’s just the same procedures but same instrument in a different language.” [010]

Perceived burden upon researchers

“In terms the Research Ethics Committees, there is quite a lot of debate there about what they are indicated to do. Again, it’s about striking this balance between what’s necessary and what’s going to place a tremendous burden on the investigator. I think usually they are looking at the location of the research, combined with asking, ‘Is it a disease that might specifically affect particular groups?’ … It’s not physically possible, I think, to always ask investigators to do a translation in every single possible language because there are just so many.” [041]

Using English as the default language

“One of our eligibility criteria was that patients had to be able to converse in English to a high enough level to be able to complete the questionnaires.” [016]

Incompatible study design

“The General Practices were randomised to be invited to [the study] … so we did not have any choice over the practices … There wasn’t really the opportunity to do anything different. I think if we realised at the outset that we were not including as many ethnic minority men as we would have wished, we might have targeted some areas with higher levels of ethnic minorities but we did not notice that really until we looked at the final baseline figures.” [028]

 Facilitators

Ensuring diversity through review process

“Ethics committees are often the ones where this is discussed … and so you might put an eligibility criteria (sic) in there which the ethics committee or others question and say, ‘Could you broaden that out? Why does a patient need to be able to speak English to enter the trial? Could the questionnaires be translated?’” [016]

Design study depending on target population

“Generally, also our scientific questions, you’d want those kind of geared towards the population that you are registering. So, in a clinical trial that’s focused on minority enrolment, our scientific questions for PROs would be geared towards those specific populations and the issues that are important to those patient groups but also kind of reflected in PROs that way.” [022]

Include relevant groups in study design

“Researchers were told they had to go, to the minority groups who were likely to be involved in the work. These were nursing studies by the way not major medical treatment studies, they were told they had to go to members of the communities and recruit them to be involved in helping define the objectives of the study and the measures which the study was going to use. And it worked.” [027]

Clarify recruitment aims from start

“You should not change something for the PRO [or] I think this needs to be clear from the outset so … if you have a study and you needed say three Pakistanis and ten Indian people and five Greek then you need to state this in the protocol so I would not feel comfortable in changing anything in the recruitment whilst the trial is ongoing” [040]

Ensure study design can accommodate recruitment monitoring

“It is more about the design so that the monitoring can take place on a regular basis and be monitored continually.” [029]

 Barriers

Researchers deviating from ethics-approved processes

“What we said was we were going to - we did, for the purposes of the ethics committee, if there are people who did not speak English then we would get interpreters to interpret. And, of course, one of the good things about using the EORTC is it’s been translated into many languages. The fact of the matter is I do not know. I do not think we ever translated anything into another language. So it’s a half-hearted attempt, I would say.” [017]

Unavailability of formal translations

“There are trials that are done in which the PRO endpoints are not translated into all other languages … We trust that the person who read it and talked to the patient and understood the question enough to interpret it in their language.” [001]

Capacity constraints

“I think it’s not so much the cost because that can be built into a trial with a huge budget that some trials have. It’s partly to do with the time-consuming nature of it. So, for instance, if some of your questionnaires have free-text responses and those responses aren’t in English then it is time consuming to do that at a time during the analysis when things are fairly pressured in any case. So I’m sure it is a barrier. I’m not sure it’s purely the cost. I think it’s a bit more than that.” [016]

Financial constraints

“People say, ‘We want diversity, we want this and that’, but [sighs] I, it is a fact that studies are very restricted in funding that … they are not able to afford interpreters or whatever.” [036]

Administrative challenges

“We did have some centres abroad … but I think the quality of life data was more sporadic, less likely to come back from centres abroad and I think that that’s probably an administrative thing, sending actual paper, quality of life returns from abroad is probably more than the centres abroad could cope with.” [014]

Reluctance of research organisations

“What we found … was how using many of the common depressed mood surveys desperately under-reported the amount of depression and depressed mood in African American women. They tried to push [the funding body] to allow them to use different surveys that were more appropriate, they were newer ones though. They were not like your classic ones. They received a lot of pushback back then. That was early mid-90s and they said, ‘No, these are the ones you use’.” [011]

 Facilitators

Pilot PRO instruments with target populations

“Within our regular clinical trials, when we do a PRO component it is administered to all patients, including minorities. We have specifically targeted minorities for a couple of our studies. We’ve done a couple of feasibility studies for our new, newer, questionnaires … We did an enrichment strategy where we were purposefully trying to enrol minority folks because they are generally underrepresented on our clinical trials. And so to make sure that our tools and our message were applicable across a wide range of the population we did kind of purposefully try to enrol as many as minorities as we could.” [022]

Undertake research in diverse localities

“The minority representation should be a consideration and I would think in large urban settings, there are numerous minorities and that would be a good base upon which to recruit minorities.” [029]

Monitor recruitment and address shortcomings in real time

“That could be a nurse practitioner, a member of the investigative staff. A concerted effort. Maybe they’ll say “Well we do not have enough representation with respect to minorities. What can we do to reach out?” So maybe having a member of the investigative team who is also a minority may reach out to fellow minorities in order to make Patient Reported Outcomes more accessible to minorities … [Monitoring] with military precision.” [029]

Research Ethics Committees requesting details pertaining to diverse involvement

“We just require them to tell us to what extent they are validated in other languages. Or if we are going to translate … we always want that spelled out and it’s incredible how researchers … think they can just use any old online translation tool and that’s sufficient for something as important as research tools and not do any of the proper cognitive testing and more rigorous validation of their tools in other languages … When there’s these multiple language or cultural barriers, particularly language though, people look out for how are they being delivered, can they be conducted orally. Does the person, the participant themselves always have to fill it out? What about their care giver or close family member, can they sit down with them and tell them what to do?” [008]

Signalling from research organisations of importance of diverse trial participation

“I guess, unlike PPI [Patient and Public Involvement], for instance, they might not have as high a profile in the [funder’s] materials. PPI, there’s sections on it in the application where you have to say what you are doing, how you are going to pay for it, etc., etc., whereas there is not, I do not think, quite the same level of emphasis on how you are going to make sure those people who are in your trial actually represent the patients with whatever condition it is that you are interested in. So maybe more emphasis … might nudge people to do a better job.” [016]

Tying diversity targets to funding

“At [national research organisation] actually, you have to have a plan as to how you are going to include minorities and women and that has to be signed off on. If it’s not agreed to, you do not get your money and then you have to report annually on how you are doing.” [011]

Availability of pre-translated PRO measures

“With different ethnicities obviously it all boils down to the language and feeling comfortable enough with the language and understanding the questionnaire, we have been working with the EORTC with the PROs and quality of life questionnaires in different countries because these are multi-national studies so we have translations of those PROs in the different languages and in some countries they used the local language and English and maybe a second or third or fourth language, so this can be done.” [040]