At Brigham and Women’s Hospital (BWH), oncologists who’ve been doing gene therapy trials for a decade are teaming up with researchers in other fields to apply their knowledge to the new wave of non-oncology cell and gene therapy studies and avoid recreating the wheel.

And at Beth Israel Deaconess Medical Center (BIDMC), one researcher’s challenges enrolling Black patients for a diet intervention study led to the development of a satellite center at a community-based clinic, which other researchers are exploring for their own studies.

These are among the ways Harvard Catalyst’s Connector sites facilitate and accelerate clinical/translational research across the hospitals affiliated with Harvard Medical School (HMS). Connector links investigators to the medical centers’ sprawling clinical research enterprises and troubleshoots research bottlenecks. (Boston Children’s Hospital and Mass General Hospital also have Connector sites.)

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The premise behind Connector is that clinical research can be challenging, especially in complex academic healthcare environments. Individual scientists can’t do it alone. Connector sites help researchers get science done right–hopefully the first time–while maintaining the highest standards for patient protection, regulatory compliance, and quality.

Connector draws upon the collective expertise of HMS-affiliated institutions to guide studies through the lifecycle of science. For investigators struggling to recruit or wrestling with logistics, the programs offer a kind of life-raft of resources and support, big or small.

As the administrative directors of Connector sites at BIDMC and BWH, respectively, Michelle Beck and Yemi Talabi-Oates are like the Ghostbusters of translational research: They are “who you gonna call” when you’ve got a research problem to solve.

We caught up with them both in one Zoom to find out what they wish investigators knew about Connector.

What’s your cocktail-party summary of what Connector is?

MB: A cocktail-party summary is hard because Connector does a bit of everything, depending on what the investigator wants. Connector sites are really good at figuring out how to set studies up. Our special sauce, so to speak, is the experience in knowing how to make things work.

“Connector sites are really good at figuring out how to set studies up. Our special sauce, so to speak, is the experience in knowing how to make things work.”

At BIDMC, Connector encompasses our Clinical Research Center, a full-service operation providing research coordination and personnel for the lifecycle of a study, including recruitment. We provide laboratory, dietary, specialized nursing–because research nursing is a little different than clinical care nursing–and all affiliated services for inpatients and outpatients in our own research space as well as in other locations.

We help research teams get the tools and resources they need in other parts of BIDMC or across the network of HMS-affiliated hospitals. We might refer them elsewhere or integrate their research into our portfolio.

YTO: Brigham’s version of the Connector is the Center for Clinical Investigation (CCI). We call ourselves the home of clinical research. We are the first stop if an investigator needs help or wants to learn how to implement clinical and translational research studies.

Investigators can use any or all of our resources, from something small to running the whole study. We can connect them with potential collaborators or just find somebody to read an EKG, if that’s what’s needed.

We have clinical space dedicated to research so we can accommodate patient visits. But just as importantly, investigators have access to vital services that are not patient-facing, such as data management, research coordination, and biostatistics support.

What do you wish investigators knew about Connector?

MB: People sometimes think that Connector is the CRC. While it is at some level, it’s also much more. Our strength lies in the collective experience of the many people who have already figured out how to design and conduct high-quality studies, who understand the steps for getting from point A to point B.

Our program director regularly meets with investigators to provide feedback on their grant applications, offer advice on how to find funding, or connect them with mentors.

All of the Connector sites have a role called a navigator. BIDMC navigators are experts in regulatory and operations. Depending on when they’re brought in, they can point investigators to resources or work through specific aspects of their study that might be challenging.

YTO: What I find with investigators is they don’t know what they don’t know. They may come to us with one question and not realize how many other things need to be considered before we can address that one question. Having that dialogue as early in the process as possible will help the investigator in the end.

Connector lets investigators tap the experience of a diverse clinical research team, whether it’s the nurses on the floor or a physician-investigator who’s done this before. It’s about knowing your patient population and what works with recruiting, right down to which time of day is easier for patients. It’s helping avoid the pitfalls that may come with being a newbie to research.

“Connector lets investigators tap the experience of a diverse clinical research team, whether it’s the nurses on the floor or a physician-investigator who’s done this before. It’s helping avoid the pitfalls that may come with being a newbie to research.”

One of the things I often say to early-career investigators or those testing a really novel idea is if you’re going to fail, fail fast. It’s okay to fail because you can use what you learn to make the next study better.

Give us an example of something you’re engaged in right now that illustrates how the Connector sites work.

YTO: One of our big pushes right now is to help investigators in the non-oncology space who are interested in conducting cell and gene therapy studies. We don’t want to recreate the wheel, so we’re connecting them to oncology physicians who have been doing these studies for a while. We’re bringing together players who aren’t otherwise talking to one another to figure out how current systems might be adapted for studies outside of oncology.

MB: We have a general medicine investigator who is running a diet intervention study for hypertension, focusing on enrolling Black Boston residents in areas with ‘food deserts’ –areas with grocery store scarcity. This investigator met with our Connector team early in his grant planning process. His studies are now funded, and he’s running them through our main Clinical Research Center at the Boston campus. But he is having a really hard time meeting his recruitment goals, so we are working with him to set up research support at our Bowdoin Street clinic.

Because of that collaboration, the clinic is being developed as a CRC satellite with a focus on community-engaged research that allows the local community to provide input on the studies conducted there. We are now working with other clinical groups to expand research at the site.

So by addressing a recruitment problem one investigator was having, we’re establishing a resource that other investigators can access to bring research to our community and potentially improve participant diversity in their studies.

Connector’s goal is to accelerate translational science, in line with the mission of Harvard Catalyst and other clinical and translational science programs funded by the National Center for Clinical and Translational Science (NCATS). From your perspective, is clinical research efficient enough?

MB: I think sometimes we have unrealistic expectations about efficiency. I honestly believe that we make things very efficient in our programs and within our institutions, but I don’t think clinical research itself is efficient, through no fault of our own.

It’s really difficult to run a study, especially if you think about the whole lifecycle. For an industry-initiated clinical trial for example, a sponsor wants you to have a budget, contract, IRB approval, and be ready to enroll your first patient within 60 days of being selected as a site, which is crazy. It’s not impossible but it’s highly unlikely, with so many steps and the complexity of various studies.

If you move too fast, you risk making mistakes. If you don’t think carefully about what’s involved in a study from a participant’s perspective, for example, you might meet your recruitment goals right away but have 60% who don’t meet inclusion/exclusion criteria at screening and 20% who didn’t realize they’d have to come in every day for the next six weeks. Those kinds of circumstances can be largely avoided with the right planning.

YTO: We definitely take some time on the front end to get all the information and tweak things where necessary to make sure the patient’s experience and the study team’s experience is positive and efficient. We want to make sure it’s done right, and that might take a little longer.

In the end I’d rather be confident that patients are safe and the data is accurate because we thought these things through up-front. That’s the time to do it, not when the patient shows up for the visit or the investigator sits down to write that paper with flawed data.

How does Connector affect the experience of patients involved in clinical research and why does that matter?

MB: Using a Clinical Research Center is hugely beneficial from the participant perspective. We had a study many years ago in which two people came in every month for seven years for the same study. They got to know each other, and they knew all our staff; they would even bake banana bread for the research center staff. I think if patients get to know the research center, that’s another mechanism for patient retention, particularly for longitudinal studies.

YTO: Agreed. Our nurses and clinical staff on the floor definitely make connections with the research participants, and they often learn something that could be valuable to the study team. Having that connection is key.

It’s not just the study team; it’s every member of the staff. It’s the person who smiles when they walk in the door, or the one who knows about their child or their cat and asks about it. That matters when you want a patient to come back again and again into the next month or year.