The Wyss’ Clinical Research Team plays a key role in a product’s journey from bench to bedside, ensuring research runs efficiently while following important regulations
By Jessica Leff
At the Wyss, we believe that breakthrough discoveries can’t change the world if they don’t leave the lab. One key step in a technology’s journey from bench to bedside is clinical research. Clinical research uses human subjects or human materials to better understand how to prevent or treat a disease or condition and promote human health. Before a therapeutic, diagnostic, or other piece of medical technology reaches clinical research, it is often the subject of preclinical research. These studies provide foundational information for future safety and efficacy testing. Prior to initiating this work at the Wyss, research teams typically work closely with our Clinical Research Team (CRT), making them vital to translating technology for near-term impact.
So much more than the IRB Team: protecting study participants while decreasing research barriers
Often when people think of clinical research, one of the first groups that comes to mind is the Institutional Review Board (IRB), a group that has been formally designated to review and monitor protocols to protect the welfare of human research subjects. The CRT does work closely with Harvard’s IRB offices, but they themselves are not the IRB and this is not their only role.
Sarah Sullivan, the Clinical Research Manager, explains, “Clinical research at the Wyss Institute and SEAS (Harvard John A. Paulson School of Engineering and Applied Sciences) is inherently complex. We have fast-paced researchers, dynamic teams, and cross-disciplinary collaborations, all happening with tight institutional, federal, and international regulations. Our team’s job is really to help all these investigators navigate those rules.”
This is incredibly important, as researchers are juggling competing priorities. While developing new medical technology is important, it also brings potential risks when it comes to human subjects testing or eventual use by patients. If something slips, like regulations or protocols are not adhered to, researchers can lose funding, ruin their reputations, or most importantly cause unintended harm to another person. Following rules and best practices ensures participant safety, reproducibility, and data integrity, which can help researchers to balance the exploration of new devices while maximizing safety for study participants, ultimately leading to safe and effective medical technology.
Years ago, the CRT successfully supported researchers with their development of a therapeutic vibrating mattress for infants. Because the research needed sick, premature infants who could not consent themselves, this study was particularly difficult to implement. Luckily, the hard work of the CRT paid off and continues to do so, even today. Jim Niemi, M.S., Senior Director of Translational R&D, remembers, “The CRT helped us navigate these challenges and established the framework for what would become a very successful clinical study resulting in, not only a published paper, but also the validation of our technology. These both contributed to the successful translation of the technology with a license to the startup company Prapela. This past year, the FDA had questions about this study, and the CRT was able to produce the forms used to recruit and test each subject many years prior.”
So, Sullivan concludes, “Instead of being seen as barriers to progress, the rules and regulations can serve their intended purpose of protecting study participants and enabling safe, translational, and fast-paced research.”
Above all else, Dionna O. Roberts Williams, M.S., M.P.H., the team’s leader, says, “We are a team of clinical researchers integrated with project teams from a study’s start to finish. We’re here to support these teams and increase productivity while keeping everything in compliance.”
A unique team of clinical researchers
So, who are the members of the Clinical Research Team, and what do they do besides working with researchers, the IRB, and other regulatory offices? Roberts Williams, who started at the Wyss in August 2015, and is the Director of Clinical Research and Director of the Clinical Translational Research Core, oversees the entire clinical research portfolio at the Wyss and human subjects research at SEAS. She develops protocols and standard operating procedures for the Institute, coordinates collaborations, agreements and clinical trial insurance, manages COMS (Committee on Microbiological Safety) protocols, and oversees research governance. She also serves as a primary liaison between various government, funding, and regulatory agencies and the Wyss. Roberts Williams was once a competitive cheerleader. She now uses her spare time to quilt and create unique bags and purses.
Sullivan has been at the Wyss since June 2016. She manages the clinical research portfolio at the Wyss and human subjects research at SEAS. Her duties include managing the day-to-day operations of the clinical research portfolio and the team, developing and maintaining protocols, facilitating device review, and managing clinical trials. Sullivan swam in college, and since then has been an avid runner.
Xiyuan (Ada) Huang, M.Ed. started at the Wyss in June 2021 and was joined by Keysa Garcia in August 2022. Both are Clinical Research Coordinators. Together they coordinate studies, implement protocols, manage regulatory files, and train and onboard other teams. They also screen, consent, and enroll study participants. Huang got into photography in 2011 and has since enjoyed the opportunity to hone her skills and work as a freelance portrait photographer. Garcia is addicted to game shows and hasn’t missed an episode of Jeopardy! since 2015.
While having clinical research support is common, the way our team functions is not. Roberts Williams explains, “What makes us unique is that we are a fully staffed team, working at every level of research, and are centrally budgeted to help all Principal Investigators. This makes our clinical research portfolio quite large and one-of-a-kind.”
Communication is key
The CRT fosters a collaborative, supportive, and nurturing environment. Garcia, the newest addition to the team, felt this immediately, “The minute I finished my interview with Dionna and Sarah, I felt like we were part of a sisterhood. Everyone has been incredibly welcoming.” Huang adds, “Our team members are excellent at getting back to each other with supportive help. We are like a small community or even a family.”
They constantly assist and interact with one another. In addition to sharing their expertise, everyone on the team is willing to learn so they can grow.
Support and communication are essential, especially because their work spans different project teams, Wyss administrative and operations teams, Harvard departments, and even collaborating institutions. For example, Senior Compliance Officer, Katrin Duevel, Ph.D., typically works with the CRT when there is a financial conflict of interest related to an IRB protocol. But Duevel has also worked on more complex projects with the CRT, like how to perform a study overseas. She says, “There were a lot of considerations and questions that came up beyond what we usually deal with. It is always a lot of fun to brainstorm with the team.”
All roads start with the Clinical Research Team
Because most clinical research at the Wyss goes through the CRT, its members have had the opportunity to work on a wide variety of projects across different disciplines. Sullivan says, “The Wyss Institute is so cool. When I think of all of the studies I have been able to work on, especially the ones that I have seen from initial research then watched spin out into startups, it is amazing.”
One technology platform they’ve worked with extensively is the wearable exosuits developed in the lab of Associate Faculty member Conor Walsh, Ph.D. Sullivan remembers meeting with members of the military when the initial research was being done as part of DARPA’s Warrior Web Project, “The collaboration between the Walsh Lab and DARPA was amazing because of the way it connected the technology to the real world. The Walsh Lab team would test at various military locations and it was always fun to hear what the soldiers and military leadership thought.”
Now, three different soft wearable robotics devices have been licensed out – one for lower-extremity mobility to ReWalk Robotics, a glove for neuromuscular rehabilitation to Imago Rehab, and one for back support in industrial settings to Verve Motion. Walsh explains, “Advancing new wearable technologies from fundamental research to patients requires performing human subjects research and clinical studies to both guide their development and demonstrate their value. Without the support of the Clinical Research Team, we would not be able to perform our research and new technologies would never leave the lab.”
The CRT is still supporting this technology through an NIH-funded industrial clinical trial for of one of these innovations that is a first-of-its-kind for Harvard. As part of the trial, the team traveled out of state together to enroll and consent participants. Huang and Garcia both cite this as their most memorable experience at the Wyss thus far, with Garcia sharing, “I got to try on the device and that was mind-blowing.”
But it’s not all exosuits – Seun Araromi, Ph.D., a postdoctoral fellow, is leading the MyoExo project, an at-home smart, wearable sensor device to diagnose and monitor Parkinson’s Disease. He says, “Without the Clinical Research Team’s persistence, creativity, and enthusiasm, the project would not have gotten off the ground. We had a challenging study design using human subjects, and they found a way to get it through ethics approval while maintaining participant safety.”
Girija Goyal, Ph.D., a Senior Scientist, explains that members of the CRT have been incredibly helpful, especially in a recent project for patients with Lyme Disease. “Getting our IRB protocol approved would not have been possible without their knowledge, network, hard work, and enthusiasm.”
Having an impact
Niemi not only works with the CRT as a researcher, but also as a member of the Harvard Medical School/Harvard School of Dental Medicine IRB. This role has given him the chance to see their work on studies he is not directly involved with. He says, “In my opinion, the Wyss CRT consistently manages, with excellence, some of the most unique and complex studies across all of Harvard University. There is nothing more important than what they do to ensure the protection of human subjects who volunteer to participate in our clinical research.”
The CRT is there to support researchers at every step of a project, and works hard to implement their ideas and reach their goals, which usually include their technology reaching patients. “Every study leaves an impression,” says Garcia, “because you see how the work can affect the future and have a major impact on populations that really need help.”