Learning the ropes of clinical trials to bring cures to patients
When Matthew Baker began his Ph.D. training at Mayo Clinic Graduate School of Biomedical Sciences, he became fascinated by the neurobiology of addiction. Baker worked in the lab of molecular pharmacologist Doo-Sup Choi, Ph.D., and his thesis project focused on identifying distinct firing patterns in the brain related to addictive behaviors — areas that might be targets for treatment.
Dr. Choi's research involves numerous collaborations with Mayo clinicians that connect basic science findings to emerging drug discoveries and, eventually, to clinical trials. Baker likes the idea of a career that may bring potential cures into patients' lives. "I hope to translate discovery into treatment that can be applied to improve human health," he says.
But research based on people is different from research based on cells. To understand some of the steps involved in clinical studies, Baker applied through the Graduate School to conduct a two-month internship away from the lab bench, learning about the later steps of the research continuum. His internship took place with Mayo Clinic's Office of Clinical Trials. "I wanted to learn the overall logistics of human research studies, what's involved in a research protocol and how it's carried out," he says.
Every study is unique
The Office of Clinical Trials turned out to be just the right place to gain that sort of insight. Established as a centralized resource in 2016, the office helps investigators on all Mayo campuses address questions as they develop studies that involve human participants. The principal investigator of a study is responsible for the clinical trial, which includes protecting the rights, safety and welfare of study subjects and ensuring the integrity of the data. The office provides education and guidance for the investigator and members of the research team.
"We are heavily invested in educating and helping develop not only a strong workforce but also future leaders for the clinical trials effort at Mayo. We provide both project management and consultative support to help develop, initiate, conduct and translate high-quality and high-impact clinical trials to bring hope and solutions to our patients," says Naveen Pereira, M.D., medical director for the Office of Clinical Trials.
Some clinical trials require significant orchestration. Clinical research coordinators are trained to help carry out the day-to-day steps of each trial, facilitating the outreach to people or the availability of samples, obtaining consent from patients and collecting data.
It's no small feat. "Every clinical trial protocol is different," says Jane Smith, a clinical research study coordinator who has been involved in research for 25 years and who oversaw Baker's internship. The protocols may have different requirements and regulations if the sponsor of the trial is from the pharmaceutical or device industry, a government grant or another funding source, such as a foundation. The office connects with other Mayo offices — such as the Office of Research Regulatory Support and the Office of Sponsored Projects — to ensure compliance for each study. "It was eye-opening to learn how much coordination is involved," says Baker.
A glimpse behind-the-scenes
During his internship, Baker received an introduction to clinical trials through lectures and readings, getting a glimpse at how studies are conceptualized, the process of monitoring their progress, the regulatory requirements and the necessary documentation. In some studies, patients provide permission for researchers to access health information. Some studies ask patients to be active participants. The clinical trials coordinators help determine whether patient-participants need to come to Mayo or can engage virtually, or they may help establish how often patients are queried or answer a questionnaire. "Because no two clinical trials are alike, the clinical trials coordinators need to learn each protocol individually and review and evaluate the processes that will meet the objectives of the study," says Smith.
Baker also spent time shadowing clinical research coordinators working on protocols that were underway, one a study of smoking cessation, and another, a study involving genetic testing for early detection of cancer. One of the most important aspects, he says, was learning about the process of obtaining consent from patients.
"I gained appreciation for how much is involved in patient interaction: the commitment to visiting and spending time with study participants, having conversations with each and every subject that signed up to be screened and making sure they understand what a study is asking of them before they sign up," he says.
"It's not a one-time interaction, either, but can be an ongoing process of obtaining consent as the trial progresses, and patients can pull out at any time if they want to. And then there's considerable planning, so that if someone participating in a trial does show up with a sign of an early cancer, there's a pre-determined plan for clinical care and follow-up."
Baker, who graduates this year, intends to pursue a career in translational and clinical research and is enthusiastic about having learned more about the route from discovery to potential cure. "I hadn't really given thought to the relationships — the ongoing connection and the sensitivity — that it takes to develop an effective clinical trial," he says.
That perspective can be essential in helping students along a professional path. "Through our personal and professional development programs at Mayo Clinic Graduate School of Biomedical Sciences, we can connect students with academic, research and industry partners within Mayo Clinic and beyond," says Christopher Pierret, Ph.D., assistant dean of academic affairs, who oversees the Graduate School's Career Development Internship program.
"The internship was definitely just a snapshot of the entire clinical trials process, which can be many years," Baker says, but the experience helped bring more focus to his long-term goals.
"I'm interested in making scientific discoveries that can translate into actionable treatments or therapies," he says. "I understand more about the process now and hope to be involved in the whole continuum of research to have that kind of impact for patients."
Mark Lewis is an advocate for participating in clinical trials. He hopes to inspire others to join clinical trials for "the greater good."
Meet three Mayo Clinic research pharmacists working to investigate new pharmaceuticals and drugs as key members of multidisciplinary research teams.
Clinical research coordinators are often a patient's first point of contact in the research process and play a central role in the successful execution of clinical trials.