Theme 1. “Poor definitions” and “Translation is in the eye of the beholder”.

The terms of reference we use in CTR emerged as a barrier. Who qualifies as a stakeholder, what constitutes engagement, and how one understands translation were all points of confusion and contention. While definitions exist, there appeared to be a lack of shared understanding among many participants.

Whether research is deemed translational may be a matter of definition. Some participants felt uneasy with the general concept of “translational science” and viewed it as at odds with the fundamentally incremental nature of science. Some worried that a “rush” to translation could lead to skipping steps or avoiding interesting avenues of research that could lead to new discovery. One researcher said,

I struggle with the definition of what’s ‘translational research’ and who our work is supposed to affect. I think by using the word ‘translational,’ you tie it directly to patients, yet work in disease models is the fundamental first step to this. And so I guess I’m just somewhat uncomfortable even with the term ‘translational research’ in this whole need to directly tie everything we do immediately to some end outcome.

Another researcher suggested a different emphasis is needed to address research in T0 and T1 settings:

We really have a push at NIH to be translational and I don’t think that people really understand what that means…It doesn’t mean that you don’t do basic science or that everything has to be a model of some disease…[The] frustration is [with] the idea that every scientific work has to be transformational and not incremental.

Participants also shed light on what defines a stakeholder and which stakeholders are important in their work. No one disagreed with the definition of stakeholders that we put forward, the same one that is presented in frameworks for identifying stakeholders in T2 through T4 CTR(2)–namely that stakeholders are those who make decisions with evidence or are affected by the decisions that are made with evidence. However, several participants pointed out that this previous framework’s call to scan the “7Ps” (patients, providers, payers, purchasers, product makers, policy makers, and principal investigators) for relevant decision-makers obscures a necessary emphasis on involving one “P” in particular: the principal investigators (researchers, research entities, and research funders) doing similar basic science work in other disciplines. This special emphasis amounts to a call for multi-disciplinary research to broaden the evidence base before basic discoveries begin translation to humans: “There’s a lot of stuff in the ‘Stage 1’s’ of translational research that requires a lot of intensive investigations for a lot of potential applications.”

Recommendations to address Theme 1.

Researchers expressed a need a for better direction from NCATS and their CTSA hubs about the terms of reference surrounding engagement work in early stage translational science: definitions of translation need to allow for discovery research to proceed without being linked strictly to a clinical, intervention, or product pathway; identification of relevant stakeholders should start with an emphasis on researchers and research groups representing multiple disciplines; and guidance on identifying relevant stakeholders should shift to the “7Ps” framework only as clinical applications, interventions, and product pathways emerge from discovery.

Building the case for using T0 and T1 evidence in other applications often involves collaboration with a cohort of other principal investigators, often a multi-disciplinary team, before the work can progress from early stage to latter stage research. As careers progress, the more distal end users of T0 and T1 work may become apparent, as the investigator sees their work wending its way into T2 and T3 settings. Here, the end users may be the full complement of stakeholders: “We all want to feel that what we're doing is important and will one day lead to something, whether it’s directly from what we conceive or it might be a step in the process…That maybe we don't have the magic, but what magic we develop will be able to be part of the step, then, to the final process.”

Theme 2: “No instructions” and “Tell us what to do, in what order”.

The second theme that emerged was a skills barrier: This is the skills issue: absence of guidance, training, mentorship and skills.

For early career investigators the absence of training on practical approaches to stakeholder engagement is a barrier. For instance, a junior investigator said he did not need to be sold on the concept of stakeholder engagement in translational science; he bought it, “hook, line, and sinker.” What he lacked was instructions about which stakeholders to engage and when in the process to engage them:

I don’t even know what that pathway is. There’s not really a trail that says, ‘Do this, then do this, then do this. Speak with these people along the way.’ I don’t know what the path is or who the path is through, I just know very broadly where it needs to go.

Another echoed this comment: “Everyone wants to translate something, right? It’s a buzz word. Everyone wants to do that thing or say they’ve done that thing, but the ‘hows’ are not as well defined for at least people in my space.” Similarly, some participants talked about a lack of training in the mechanics of translating bench discoveries into clinical applications, interventions, or products. For instance, one participant focused on administrative hurdles they discovered when working with industry on patents and licensing: “[I] feel as a junior faculty that I don’t necessarily have the commercial training nor the time to learn this skill as I would perhaps after tenure.”

Some researchers reported lacking the skills necessary to communicate scientific ideas to lay audiences in simple but meaningful ways. Good science communication skills were seen as crucial: “No matter how good their ideas, you have to be able to explain it to whoever it is you're talking to if you want them to pay attention;” but lacking: “Scientists aren’t exactly the best spokespeople for their own work much of the time.”

Lack of mentoring was also challenging for junior faculty. Variations in the culture of the discipline, department, or institution could also lead to researchers feeling isolated or silo-ed. “I feel a little isolated where I am. I don’t necessarily have a mentor to help guide me in a lot of the decision processes that I’m making.” The clinician-researcher role was seen as better established in some fields (cardiology) than others (gynecology), although this may vary between institutions, and this impacted both the availability of protected research time for clinicians and the availability of mentors. In non-clinical fields (chemistry), the proximity (or lack thereof) of the department to the healthcare setting could also create a barrier:

Very few of my colleagues are involved with anything that is beyond foundational basic research. And even fewer are involved in anything related to healthcare. I don’t necessarily have a mentor to help guide me in a lot of the decision processes that I’m making. That just adds to a feeling of isolation and flying by the seat of pants in not being savvy regarding who I contact about collaborations or grants because there’s no one telling me, ‘That’s a dumb idea, that’s a good idea.’

Recommendations to address Theme 2.

Several recommendations were made to address the barriers described by skills-related barriers. These include: training that folds engagement work into researcher education, creation of practical “how to” guides on engagement work, and more opportunities to use mentoring in CTR, including on how to identify and become engaged with potential en-users of the work.

You have at least two junior faculty members [here] that are begging for this sort of pathway forward. Tell us what to do, in what order, how to contact people, when’s the right time to engage this stakeholder and this stakeholder and this stakeholder.

CTSA hub investments in mentorship programs were identified as a way to overcome these barriers. After describing the absence of a clear clinician-research path in her field and institution, one participant said that the mentorship she encountered through her institution’s CTSA from colleagues outside her field had greatly benefited her: “One thing that [the CTSA] has given me that’s been a real boon is the mentorship…without that, I couldn’t have done it.”

Theme 3: “Competing demands on resources” and “lack of resources”.

Material resources to support research were viewed by our discussion participants as scarce, may have strings, and difficult to come by. All of this puts pressure on researchers to choose among the many competing demands of research, and stakeholder engagement can fall off the radar without funds that are directed specifically to that purpose, or without funding criteria that call for it.

Having protected time for research was one of the most basic challenges. Junior faculty without established research portfolios felt this acutely:

My chair is very morally supportive but nobody gives you startup money or protected time. So I started out, after my Fellowship, doing 100% clinical, and I had to rearrange my time in order to have a little bit of research time that wasn't 9:00 at night. That was very stressful, because I have the research knowledge, but I didn't have the time or energy to do it. And, slowly, I've crawled my way to having more protected time through luck and opportunity and meeting people–enough protected time that I was able to apply for this award [institutional K], but it's taken me four and a half years.

A tight funding climate was described by all participants as a barrier to adding stakeholder engagement to their list of priorities, but tight funding presents a unique challenge for junior researchers. Some participants described being unable to find a “home” in the National Institutes of Health (NIH), because their research interests do not line up with individual Institutes and Centers of NIH: “I don't really have an institute in the NIH where I can apply very easily.” An early career researcher said, “The mentality of the tenure track is just go, go, go, go, go, which is great. But sometimes I just wish I had the time to just sit back, think logically of the next step.”

Some participants described funding challenges in another context: the misalignment of industry profit motives and the patient or public health goals of researchers. Returning to an earlier example of a research who wanted to prioritize the health of humans over livestock, they state: “We have licensed an antibody that we developed to use for treatment of [this bacteria] … I’ve sort of hit a wall against finding somebody who is interested in, in developing the technology or marketing it for use in developing countries because there’s no money in it.”

Recommendations to address Theme 3.

To successfully engage stakeholders in the earliest stages of translational research, researchers need material resources that are specifically targeted to that purpose. CTSAs are in a unique position to deliver many of these material resources, and participants recognized this:

I think that the [CTSA] is an important space that values research and, maybe, could do some more pushing or open up some more opportunities for people who are in the clinical field that really would like to pursue research.

Participants had the fewest suggestions for how to address funding barriers. Everyone recognized it as a problem, but no one purported to have the solution. It may be this is where institutions, such as NCATS, need to take the lead in helping to create structures that support protected time for research and access to funding which prioritizes stakeholder engagement especially for researchers in the earliest stages of CTR.