Q&A with Dr. Jean Ford
In the video that accompanies this overview, Dr. Jean Ford elaborates on the framework and provides how the framework can be used to improve the accrual of underserved populations to clinical trials.
The Ford Conceptual Model
Ford and colleagues (2005) developed a conceptual framework to guide their study of the recruitment and retention of underrepresented populations to cancer-related trials. According to this framework, in order to accept or refuse trial participation, an individual must first be aware of the trial and second, must have the opportunity to participate. Recruitment barriers and promoters span the continuum from awareness to acceptance, and they differ, depending on the population and the type of trial (treatment trial vs. prevention trial). The Ford model is shown in Figure 1 below.
In brief we describe some of the factors that may influence recruitment and retention (from awareness, opportunity, to acceptance/refusal) as highlighted in the AHRQ report and conceptual framework.
Clinical Trial Awareness
Multiple factors can influence clinical trial awareness
- Knowledge at this point in the recruitment continuum spans many categories. It includes the potential participant understanding the general nature of clinical trials as well as specific details about a particular clinical trial of interest (e.g., anticipated outcomes, information about the disease, the costs of participation etc.).
- An important belief that is often overlooked by researchers is the potential participant’s belief in his/her ability to successfully participate in the trial – in the Ford et al. conceptual framework, it is hypothesized that someone who does not have a level of confidence regarding trial participation may not be open to learning more about the clinical trial opportunity.
- The organizational environment in the model reflects both the psychosocial and physical environment in which recruitment efforts take place and/or the trial occurs. Potential participants may be more or less open to learning about clinical trials depending on how the organization makes the individual feel – (e.g., welcomed, defensive, etc.) Health literacy also influences trial awareness.
Opportunity to Participate
Multiple factors can influence the opportunity to participate as outlined in the conceptual framework.
- Provider factors are important at this point in the recruitment continuum. Specifically, providers (e.g., oncology providers) may be influenced by their knowledge of specific clinical trials, general beliefs regarding clinical trials, and their beliefs about their patients’ ability to enroll and successfully complete a trial. As providers frequently refer potential participants to clinical trials, all of these considerations likely have an impact on referral patterns and decisions about which patients are offered the ‘opportunity’ to participate in a research study.
- Characteristics of the trial and the trial setting also influence the opportunity to participate. These factors include access to locations where the study will be conducted (e.g., access to a health care facility) and specifics related to study design (e.g., inclusion exclusion criteria).
Acceptance or refusal to participate
As reflected in the conceptual framework, multiple factors influence an individual’s acceptance or refusal to trial participation. A few of these factors are noted below:
- At this point of the recruitment continuum, trust can play a significant role. Trust may involve the trust of the institution conducting the trial, the sponsor of the research, and/or trust in the investigator/physician/research staff.
- Previous experience either with a cancer diagnosis or prior exposure to a clinical trial may also influence willingness to participate.
- The perceived benefits of trial participation can also influence willingness to participate.
- An important component of this conceptual framework is the sociodemographic factors that are hypothesized to influence the barriers and promoters of awareness, opportunity, and willingness to participate in trials. So for example, a researcher designing a recruitment plan would consider how sociodemographic variables (e.g, culture, age, gender), for example, influences barriers and promoters to recruitment across the recruitment continuum (i.e., awareness, opportunity, and acceptance/refusal).
Welcome to our interview with Dr. John Ford, Associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. Dr. Ford also serves as the director of the John Hopkins Center to reduce cancer disparities and the associate director of community programs and research for the Sidney Kimmel Comprehensive Cancer Center. How did you first become involved in minority recruitment efforts?
Well I first became involved in minority recruitment efforts when I was in Harlem I was leading asthma clinical trials and at that time we were trying to recruit a population that historically had not participated much in trials, and we quickly realized that some characteristics of the population led us to have difficulty. So I began to investigate why it is that this population was less likely to get involved But then when I came to Hopkins several years later it became evident that this was also a problem with respect to cancer clinical trials. There was a funding opportunity and i jumped at it and i have been doing this work more intensively since. How did you become interested in studying the recruitment of minority populations into cancer clinical trials?
As I mentioned, we conducted the systematic review of the literature with support from the AHRQ and funding from the National Cancer Institute to try to understand what are some of the factors that constitute barriers to minority participation, also participation of underrepresented populations in general in clinical trials and there is a vast literature in this area and that sort of peaked my interest in terms of what could we take out of this and potentially relate to our own local population here in Baltimore.
In the twenty years since the NIH mandate to investigators to increase minority enrollment what progress has been made? Well that is a really good question, I think that there has been a lot of progress made in the 20 year and pretty much concurrent with that was a doubling of the NIH budget close to that and clinical trial accruals rose in general, but not all populations benefited at the same rate. But still during that time we’ve seen a rapid proliferation of articles in the literature about minority accrual to clinical trials, and that proliferation I would say has accelerated even over the past few years. There has been a lot published about barriers.
In fact in our systematic review, we’ve identified a hundred and fifty distinct barriers that were documented in the literature. This was as of 2005, but there has been less progress with respect to developing evidence based solutions in terms of things that we do that we know are likely to work in improving minority accrual to clinical trials.
Please give us a brief overview of your conceptual model and how it is practically applied to study the recruitment of minorities in clinical research. Well first let me say that this conceptual framework, as probably any conceptual framework, has an intellectual pedigree because we started out from the work of my colleagues, Tiffany Gary and Neal Poe, who had developed a conceptual framework where they looked at both barriers to awareness and barriers to acceptance, to participation in research studies as we reflect including clinical trials. As we reflected on that on that, with respect to cancer clinical trials, it occurred to us that people may be aware of trials, but if they don’t have the opportunity to participate, then that may not necessarily translate into the potential for making a decision whether or not to participate.
So we included in our conceptual framework, which that opportunity is in fact, one of the components of whether or not someone gets to participate in the trial, and in order to participate one must be aware and have to have the opportunity to participate and given those two conditions, one has to decide.
And there are barriers that arise at every step of the way.
Could you discuss some of the documented barriers and promoters to minority participation in cancer clinical trials?
Interestingly, using our conceptual framework, we found that the preponderance of the barriers was at the level of opportunity. Both in terms of the barriers, we saw predominantly barriers to the opportunity to participate, and likewise in terms of the promoters and the literature, if you look at that constellation, it was also predominantly at the level of opportunity so this is overall the area where I think there is lot of potential although awareness and decision making are clearly critical areas that we, like others, are interested in. Now in regard to the specific to the barriers overall, the most frequently reported barrier that we saw in the literature was mistrust of research and researchers. There were other barriers that were quite prominent including the perceived harms and you know, the replica, the reciprocal of that in terms of promoters receive benefits and we saw barriers of multiple levels in terms, both at the level of individuals, institutions and the health care system and in terms of health care providers.
How do factors influencing minority participation in cancer clinical trials vary across multiple racial and ethnic minority groups? Well lets start with the easier question, even though there are cultural differences and ethnic differences and so forth we are all similar in some ways. And the Cochrane Collaboration recently published a review of the literature documenting some interventions that have worked in terms of recruitment to studies and if i recall one of them is you know, you try to get information about a study, if you get back to the non-respondents that’s one way. The other one is getting people to opt out rather than opting in. In other words, you let people know, hey we’re doing this research, if you don’t want to hear anymore about it, let us and we won’t contact you anymore.
And that’s one of the ways, one of the strategies that seems to have worked in the literature. And the third one is of course having studies that are unblinded, those are the strategies that are documented within the Cochrane Collaboration. And we found some strategies in our systematic review that applied to certain populations for example, in cancer prevention trial, a media campaign, I believe it wast the Brewster Study published in 2002, was more likely to succeed than just getting the word out in the usual way.
In terms of getting Latinos to come to clinics, that was a prevention trial. And I believe Mendel Vlad did a study published in 2005 where a brief educational intervention was more likely to get women to participate in a trial involving mammography screening. There are several other strategies that have worked, some of them from studies that are non-randomized. For example the minority based clinical oncology program has worked in terms of increasing the proportion of minority patients who are involved in cancer related clinical trials, although that has not been shown in a randomized way. So there is extensive evidence about strategies that work but in terms of studies that have looked at that have done comparisons of multiple strategies those are few and far between.
How well you think many of these recruitment strategies will work across different racial and ethnic minority groups? That is a good question many will but some won’t. And one of things to consider and there is a literature on the terminis of behavior in regards to prevention and treatment, there are different constructs and whether you talk about temporal orientation, communalism is one that is quite important.
Spirituality is very important as you know in the African-American community, but thinking about communalism you will see differences comparing African-Americans and Latinos in terms of which certain decisions are made with family members as opposed to being made on an individual basis, but what I caution is that this is really in terms of the prevalence.
We all have families and we all have relationships with our families and so extent to which communalism plays across cultures it may be different but families are important everywhere.
How can effective minority recruitment strategies be implemented with limited resources? I’d like to frame this a little bit differently because the reality is that, yes part of the expense of recruitment is the lack of evidence about what works. And what really boggles my mind is that we are scientists and this is a problem that like many other problems that we’ve solved can be solved using a scientific approach, which is why I’m so excited by the EMPACT consortium because we’re trying to develop scientific strategies to develop evidence on what really works to accrue people of color into cancer and inter-clinical trials in relation to cancer and other conditions.
So i think that the first thing is we need to research on what works within and across culture across cultures and given that evidence, we can apply it and judiciously in a way that I believe that is likely to be more cost-effective than what we do now, which is you know we try out this, or try a little bit of that. And so what we advise based on what we have observed through our systematic review is that people begin with a conceptual framework, in terms of, given the populations that they’re targeting for clinical trial, what may be some of the barriers to awareness, what may be the barriers to opportunity?
What may be the decision making barriers, so given that and given the specific population, ethnically and in terms of other demographic characteristics, age and so forth gender, what might be most likely to work with that population so they are always to really think through this and may get work better within the resources that the investigator has.
Other than participant characteristics, could you give some examples of factors related to minority recruitment in cancer clinical trials? I’m thinking about some study design barriers. For example, if you are going to plan a trial, for example, and you exclude people based on a risk factor that is highly prevalent in minority populations, and it’s much more prevalent in minorities than in the majority population, then you’re less likely to be successful in recruiting minorities based on that.
So you have to ask yourself, “Is there a biologically valid reason why you should have that particular eligibility criteria?” One of the things that happens quite often is the age criteria for older adults where people above a certain age are excluded in a trial that features a nephrotoxic drug. Well, gee, you may have people sixty-five or seventy who have a normal creatinine level.
Should these people really be excluded and there’s substantial evidence that perhaps they shouldn’t so study design barriers the logistical characteristics of the trial is a major problem, in that if in fact you’re asking who are fully employed to be doing things that are going to require lot of time and income loss and so forth those could be some issues. Moreover, the strategy that is used to introduce the trial is often something that investigators could improve. That is, is it a culturally appropriate way that you introduce it? Is the timing right?
That is if someone has just been diagnosed with cancer, is this the right time to talk talk to them about that? Often times they’re really stressed out and they’ve heard “Well, you know, you have cancer” and that’s the last thing they heard and the trial just passes them by. And certainly, not taking into account the level of literacy of the population about cancer and cancer related trials, all of that those are some examples, but there are numerous example in which, the approach of the investigators in itself represents a barrier to participation.
What aspects of minority recruitment in cancer clinical trials need to be addressed to build on passed progress? I think that there are numerous aspects that need to be addressed and it really varies depending on whether one is talking about therapeutic trials or trials of prevention strategies and for example how is it that you promote awareness about our trial, in a particular context we still need to amplify the evidence in that area, with respect to opportunity barriers and this is something that we face across various institutions. To what extent can we design a menu, lets say, of clinical trials for a given institution that is well aligned to the prevalent morbidity in the target population.
And at the level of acceptance we’re very interested right now here at Hopkins in understanding decisional balance with respect to clinical trials because there is a number of different barriers that have emerged at the level of perceived harms and benefits and so forth and it is the balance of all the issues that the individual considers that determines whether or not and of course context of the individual that determines whether or not they will consider participation. So we need a lot more work to do in these areas.
Can community-based cancer clinical trials increase minority recruitment? Well, I think that this is something that is a larger question which cannot be handled by individual institutions but I strongly believe in the Willie Sutton rule. so to speak that if you want to drop money, got to a bank for example.
If you want to find people of color, you want to go to their communities and I think that I am an example. I came into clinical trials because there was a network that NHLBI put together that realized that in order to improve minority recruitment they needed to have minority institutions and I was in Halam at that time and I competed and was funded to be initially the minority center for the asthma clinical research network and that model worked in that context. And likewise as I mentioned the MBC COP, the minority based clinical oncology program is another example of placing clinical trials in the community and getting minority investigators involved as a basis for greater inclusion of minorities into clinical trials.
Having said that, depending on the nature of the trials, there is a requisite infrastructure that may or may not be readily replicable in community based settings. For example, if we’re talking about the early phase clinical trials that are commonly done here, which require highly sophisticated tools and extremely well trained staff that use those tools frequently, it probably is not realistic to expect that those tools would be available at a lot of community hospitals.
Having said that, what we need to do is to develop strategies to link world class centers such as the ones that are involved in EMPACT with community based hospitals and community based providers so that everyone can have access to clinical trials. And that’s the really attracts me to EMPACT – that we think of ourselves as a network of networks.
It doesn’t stop with those cancer centers but the vision is that we are going to work with our local communities, including local hospitals. Do you have any other thoughts or ideas about minority recruitment to share with us? Well, I would just like to reiterate here that all things are knowable including strategies for accruing people of color into clinical trials. And what it takes is the will and the investment to really make it possible to apply rigorous scientific methods to learn how to do it better. And it can be done within the existing vast clinical trials enterprise that exist, that we have here in the United States. That studies of accrual strategies could potentially be nested across some of the multi-center groups and so forth, and I think that we just have to come with a bold vision and the resources to make that happen.