How clinical trials drive medical breakthroughs and help shape the future of health care
Are you someone willing to participate in a clinical trial so others, including yourself, could have a second chance at combatting a disease? What about being a volunteer to evaluate the safety and efficacy of potential new medications or vaccines? Since the first randomized controlled study of streptomycin in 1946, clinical trials have built a storied history with one common thread — those people participating contributing to the advancement of treatments and medicines.
Carol R. Bradford, MD, MS, FACS, dean of The Ohio State University College of Medicine, says that medical advancements and innovative patient care would not be where they are today without information and results obtained through clinical trials. Or without the volunteers who are willing to participate to assist researchers in uncovering medical breakthroughs and discoveries that improve lives.
“Clinical trials are the final step in a long process that begins with research in a lab,” Dr. Bradford says. “Most treatments we bring to the bedside today are the result of past clinical trials. These findings contribute to our ability to continually evolve to meet ever-changing demands in medicine.”
Randomized controlled trials: the “gold standard”
Ann Scheck McAlearney, ScD, MS, the associate dean for health services research, a distinguished professor of Family and Community Medicine, and the executive director of The Center for the Advancement of Team Science, Analytics, and Systems Thinking (CATALYST) in the College of Medicine, describes the ethical and regulatory evolution of clinical trials that centers scientific assessment and continual assurance of patient safety. In randomized controlled trials, study participants are randomly assigned to the group that receives the medication or intervention being studied, or to the control group that does not receive the intervention. Dr. McAlearney says this process is designed to eliminate any bias that investigators might have if they were to assign participants to groups themselves.
“When possible, neither the investigator nor the participant knows which group they are assigned to,” Dr. McAlearney says. “This is called ‘blinding’ and is another way to decrease bias in conducting the study and evaluating the results.”
Dr. McAlearney and her team have tested different strategies to encourage the use of patient portals during hospitalization and after discharge, and they’re currently evaluating whether a technique called “motivational interviewing” helps encourage pregnant individuals to reach out for assistance with social needs to improve their health and the health of their babies.
Richard Gumina, MD, PhD, serves as the associate dean for convergent research and as a professor of Internal Medicine in the College of Medicine, and is the director of the Division of Cardiovascular Medicine. He is also a physician-scientist who works to advance translational and clinical research. He leads the cardiovascular and STOP-COVID biorepositories, which incorporate a cross-disciplinary approach to moving research forward across the academic medical center.
Dr. Gumina and his talented team work to unravel the factors that contribute to cardiovascular disease by obtaining blood from their patients. This step unlocks the door to understanding the causes of heart disease using a multiomic approach and to determine how differences in an individual's DNA code affect their immune response following a heart attack.
He just received a $3.8 million, five-year grant from the National Institutes of Health (NIH) to study inflammation following myocardial infarction, or heart attack.
“Our team will determine how genetic differences that impact the function of a specific type of T cell called regulatory T cells, or Tregs, affect inflammation after a heart attack,” Dr. Gumina says. “Tregs are often dubbed the ‘generals of the immune system.’ They are critical in directing and controlling the immune response, preventing it from further damaging the body's own tissues, and also facilitating healing.”
Dr. Gumina says this clinical study will allow the team to advance our understanding of cardiac inflammation and healing, further solving factors that affect coronary artery disease and improve outcomes for patients after a heart attack.
“The ability to modulate inflammation following a heart attack may offer great hope for patients,” Dr. Gumina says. “Our patients hold the key to discovering more targeted ways to prevent, treat and cure patients after a heart attack that will lead to healthier and happier lives.”
Advancing discovery to improve health for all
For the past two decades, The Ohio State University Clinical and Translational Science Institute has worked collaboratively to advance discovery and improve health for all. Julie Johnson, PharmD, director of the institute, says the center has been an impactful resource to the scientific and research community and moving forward, it will more fully serve the entire clinical and translational research community at the Ohio State Wexner Medical Center and Nationwide Children’s Hospital.
“Our diverse pool of physicians and researchers work collaboratively to push the boundaries of knowledge to turn scientific discoveries made today into life-changing disease prevention strategies, health diagnostics and treatments of tomorrow,” Dr. Johnson says. “This innovative work holds the potential to improve health for all.”
Improving health for all entails having a diverse group of participants in inclusive clinical trials. This allows scientists to assess how a drug or intervention acts in both broad and specific populations and provides opportunities to develop treatments that seek to benefit diverse communities.
“It is important to recognize and thank all the people who participate in clinical trials,” Dr. McAlearney says. “Without their participation, medical progress would not be possible.”
