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What are clinical trials, and why are they important?

May 20, 2021

Did you know that we conduct clinical trials at Baystate Health?

First and foremost, what is a clinical trial?

A clinical trial is a research study involving volunteers that is designed to answer a specific question, such as "Does this new treatment work better than the usual treatment?" Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.

The goal of clinical trials is to determine if a new test or treatment is effective. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

Clinical trials are important. How so?

Carefully conducted clinical trials are the safest and fastest way to find new approaches that may prevent, detect, or treat health problems, or improve the health of the people in our communities. Many treatments that are now standard were first shown to be effective in clinical trials.

Did you know? Clinical trials are not necessarily treatment

When you visit your doctor, they will diagnose and treat your current illness or condition. A clinical trial may or may not help someone personally. Clinical trial volunteers agree to participate in the study to help answer the study question.

Conducting clinical trials at Baystate

Browse our clinical trials to learn more about the kinds of trials we offer. Questions about participating in a clinical trial? Take a look at our visual aid, "Why bother volunteering for a research study?"  

Celebrating our research staff on Clinical Trials Day

What is Clinical Trials Day?

Clinical Trials Day falls on May 20th every year. It is a national day to recognize clinical trials staff, researchers, and the history of clinical trials. It is also a day to bring awareness to clinical trials and pursuing clinical research as a career option.

Thanking our researchers and research staff

Baystate Health has dozens of researchers and research staff who explore the unknown every day, moving scientific and medical explorations forward.

“On Clinical Trials Day, we would like to express our gratitude to the Baystate researchers and staff who are the brains, heart and soul of our research enterprise,” said Peter Friedmann, MD, MPH, Chief Research Officer, Baystate Health, and Associate Dean for Research, University of Massachusetts Medical School-Baystate.

Learn more about the history of Clinical Trials Day.

Clinical Trials Unit (CTU) introduces Clinical Trial Specialist

The CTU is pleased to welcome Viorika Nelson, DNP, FNP-C, Clinical Trial Specialist (CTS). The CTS is responsible for assisting Primary Investigators (PIs) in directing the care of subjects enrolled in clinical trials.

What will the Clinical Trial Specialist do?

Dr. Nelson will work collaboratively with the PIs and other healthcare team members as a sub-investigator on various clinical trials. She will work at the new Clinical Trials Unit, located at 80 Wason Avenue in Springfield.

“There is a substantial need for this role,” said Judith Pride, RN, MSHS, CCRC, CCRP, CIP, Program Director of the Clinical Trials Office (CTO) at Baystate Health. “The CTU is located offsite from the main Baystate campus and 3300 Main Street in Springfield. Our investigators sometimes have competing responsibilities, which makes it more difficult to attend each study participant visit. The CTS will be available to complete required study activities when the study PI is unavailable.”

Dr. Nelson will assist with physical exams, reviewing lab results, monitoring patients, consenting study participants, and various protocol-required study assessments.

She began working for Baystate in 2001 as a registered nurse on the surgical floor. Since then, she has held other roles in cardiology, psychiatry, and substance abuse as a Nurse Practitioner (NP). On top of this experience, she has a diverse background and is multi-lingual in English, Romanian, and Russian. She has always had an interest in teaching and/or research and is excited to be the first to take on this new role.

“[I am learning that] there are lots of protocols, ensuring safety for the patients, confidentiality for the patients, and the ins and outs of the different trials,” explained Dr. Nelson.

“I think she will be a great addition to our team. It is important to have a diverse team to help contribute to diverse enrollment in our clinical trials,” added Mrs. Pride.

Growing the gastrointestinal (GI) research program at Baystate

Gastrointestinal (GI) research is a budding field in western Massachusetts. Currently, Baystate Health has 12 GI physicians, three advanced providers, and six GI fellows and residents.

Dr. Rohit Singhania, Director of Clinical Research (Department of Gastroenterology) at Baystate Medical Center, believes GI research has a great future at Baystate. His primary goal is to create an outpatient inflammatory bowel disease (IBD) clinic that serves patients with Crohn’s Disease and Ulcerative Colitis through care and therapy.

“We want to improve the care of our GI patients and provide access to investigational therapies,” said Dr. Singhania. “We are collaborating with our GI physicians at Baystate to identify how we can improve care for our patients.” This includes several funded programs so far:

1. A study for moderately to severely active Crohn’s Disease.
2. A study for moderately to severely active Ulcerative Colitis.
3. Alliance for IBD (All4IBD): A Digital Quality Improvement network for Inflammatory Bowel Disease with a goal to improve outcomes for patients through digital patient engagement.

Other recent efforts to aid GI patients are through a COVID-19 registry, led by Dr. Mihaela Stefan, as well as several resident projects submitted for publication or as posters (with a Presidential Poster Award from the American College of Gastroenterology’s annual meeting in 2020).

Clinical Trials for GI

“We are beginning our first GI studies in 2021, starting with studies for Crohn’s Disease and Ulcerative Colitis patients,” said Mrs. Pride. “The CTO will be instrumental in the conduct of the trials by providing study coordination, regulatory services, helping enroll patients and complete study visits.”

The studies were planned to launch in 2020 but were delayed due to the impact of COVID-19.

“Obviously, these efforts could not have been initiated without the guidance and mentorship of Drs. Ira Schmelkin (Division Chief, GI), Abraham Thomas (Chair, Department of Medicine), Peter Friedmann, Jay Steingrub, and David Desilets, as well as the entire team of Baystate Gastroenterology,” added Dr. Singhania. “Through these efforts, we have been able to distinguish Baystate on the forefront of GI care.”