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Our Services

Clinical Research

Service Details

Clinical research is a medical discipline dedicated to studying new and innovative therapies to help improve overall quality of life. The standard therapies, preventions and diagnoses used today to save millions of lives were at one time evaluated through the clinical research process. Participating in clinical research as a staff member, a provider, a sponsor or, most importantly, as a patient, contributes to the well-being of future generations.

Springfield Clinic’s physicians have contributed to clinical research for over 50 years. Today, Springfield Clinic has a dedicated clinical research staff that collaborates with providers to offer central Illinois patients an opportunity to participate in clinical trials. These trials may provide promising treatment options that are otherwise not yet available.

Successful clinical research requires strong partnerships between patients, providers and sponsors.

Current Trials

To date, the Clinical Research department has conducted more than 400 clinical trials and continues research activities today. Search the table below to review our current clinical trials, investigators and medical conditions under study.

Condition
Principal
Investigator
Description
Cancer

Preet Singh, MD (and Oncology Department)

Members of Heartland NCORP Cancer Research

Condition
Principal
Investigator
Description
C-difficile

Steven O'Marro, MD

A Phase 3 study of SER109 (Ecobiotic Drug) to reduce recurrence of C-diff infection in adults who have received antibiotic treatment for recurrent C-diff infection.

Condition
Principal
Investigator
Description
Chronic Cough

Renu Govindaiah, MD

Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough

Condition
Principal
Investigator
Description
Colorectal Cancer

Peter Hofmann, MD

Prevention of Colorectal Cancer Through Multiomics Blood Testing.

Condition
Principal
Investigator
Description
Colorectal Cancer

Peter Hofmann, MD

Sample Collection for cfDNA diagnostic development

Condition
Principal
Investigator
Description
Diabetic Macular Edema

Ramanath Bhandari, MD

Aflibercept vs. Bevacizumab + Deferred Aflibercept for the Treatment of DME

Condition
Principal
Investigator
Description
Diabetic Macular Edema

Ramanath Bhandari, MD

A RANDOMIZED, DOUBLE-MASKED, ACTIVE-CONTROLLED PHASE 2/3 STUDY OF THE EFFICACY AND SAFETY OF HIGH-DOSE AFLIBERCEPT IN PATIENTS WITH DIABETIC MACULAR EDEMA.

Condition
Principal
Investigator
Description
Diabetic Retinopathy

Ramanath Bhandari, MD

Intravitreous Anti-Vascular Endothelial Growth Factor Treatment for Prevention of Diabetic Retinopathy (Enrollment Closed)

Condition
Principal
Investigator
Description
Healthcare Machine Learning

Chaitanya Mamillapalli, MD

Development and evaluation of a machine learning algorithm for prediction of clinical diagnosis.

Condition
Principal
Investigator
Description
Kidney Transplant

Brad West, MD

APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)

Condition
Principal
Investigator
Description
Kidney Transplant Rejection

Bradford West, MD

Sample collection for dd-cfDNA diagnostic development.

Condition
Principal
Investigator
Description
Lung Cancer Screening

Jessica Moja, MD

Nano-Chip Diagnostic Development for Lung Cancer Screenings.

Condition
Principal
Investigator
Description
Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Ram Bhandari, MD

A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) (BEACON).

Condition
Principal
Investigator
Description
Neovascular Age-Related Macular Degeneration

Ramanath Bhandari, MD

A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.

Condition
Principal
Investigator
Description
Plaque Psoriasis

Vivianne Beyer, MD

Phase 3 Study of TYK2 inhibitor (oral) Compared to Otezla in adults with mod-severe Plaque Psoriasis

Condition
Principal
Investigator
Description
Plaque Psoriasis

Katherine Stealey, MD

A Phase 3, Multicenter, Randomized, Double-Blind Study Evaluating the Efficacy and Safety of ABP 654 Compared with Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis.

Condition
Principal
Investigator
Description
Prostate Cancer

David Lieber, MD

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Condition
Principal
Investigator
Description
Psoriatic Arthritis

Robert Trapp, MD

Comparison of risankizumab to placebo in subjects with active Psoriatic Arthritis with inadequate response or intolerance to biologic therapies

Condition
Principal
Investigator
Description
Psoriatic Arthritis

Robert Trapp, MD

Comparison of risankizumab to placebo in subjects with active Psoriatic Arthritis with inadequate response or intolerance to Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy

Condition
Principal
Investigator
Description
Rheumatoid Arthritis

Robert Trapp, MD

Long-term open-label follow up of GLPG0634 in patients with Rheumatoid Arthritis (Enrollment closed)

Condition
Principal
Investigator
Description
Rheumatoid Arthritis

Robert Trapp, MD

Oral Filgotinib given alone or in combination with Methotrexate in patients with moderate to severe active Rheumatoid Arthritis who are naive to Methotrexate (Enrollment Closed)

Condition
Principal
Investigator
Description
Rheumatoid Arthritis

Robert Trapp, MD

A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products

Condition
Principal
Investigator
Description
Rheumatoid Arthritis

Robert Trapp, MD

Phase 3 study of ABT-494 (JAK inhibitor) for patients with Mod-Severe RA who are on stable doses of DMARD's and have had inadequate response or intolerance to Biologic DMARD's (Enrollment Closed)

Condition
Principal
Investigator
Description
Rheumatoid Arthritis

Robert Trapp, MD

Phase 3 study of ABT-494 (JAK inhibitor) for patients with Mod-Severe RA who are on stable doses of DMARD's and have had inadequate response (Enrollment Closed)

Research Patients

Patients, or clinical trial subjects, are the foundation for clinical research. Medical science would not advance without brave volunteers who are willing to enroll in studies to help develop future treatment options. As a community of caring, Springfield Clinic’s Clinical Research department strives to provide the best patient-centered clinical trial experience possible.

Before enrolling as a clinical trial subject, it is important to be well informed and knowledgeable about clinical trials and clinical research procedures. 

What is a clinical trial?

Clinical trials are scientific studies that seek to answer important medical questions about new investigational treatments or existing ones. All clinical trials are performed according to strict rules set by the Food and Drug Administration (FDA) and other regulatory agencies. These rules ensure everyone who volunteers as a study subject is informed thoroughly about the trial and treated with as much of a focus on safety and privacy as possible.

What are the different types of clinical trials?

New therapies progress through the clinical research process in phases.  Each phase designs clinical trials to answer different questions:

PHASE I:  Is the new treatment safe?

Phase I clinical trials test a new treatment on a limited number of healthy people (20-80 people) to determine basic safety.

PHASE II: Is the new treatment effective against a specific health problem?

Phase II studies test the treatment on a small patient population with a specific health problem to determine effectiveness and the best clinical dose.

PHASE III: Is the new treatment effective in a large patient population? Is the new treatment better than available standard treatments?

Phase III studies test new treatments on a larger patient population to see if it works as well as available standard or current treatments. These studies generally take many years to plan, perform, analyze and complete.

PHASE IV: Is the new treatment safe, effective and affordable after it is approved and on the market?

Phase IV studies perform post-marketing surveillance and cost-benefit analyses after the new treatment is approved by the FDA.

What are the benefits of participating in clinical research?

Participating as a clinical research subject offers a potential for unique and impactful benefits:

  • Subjects may have an opportunity to access innovative treatment options that are otherwise not yet available.

  • Subjects gain access to expert advice from specialized physicians.

  • In many trials, subjects are compensated for travel and time during their participation in research.

  • Subjects have an opportunity to contribute to medial technology and help to develop future treatment options.

What are the risks of participating in clinical research?

Clinical research is planned, approved by medical professionals and performed by highly-trained staff as safely and as carefully as possible.  However, many investigative treatments are not yet approved by the FDA and may have a risk of known and unknown side effects.  Research staff will fully explain all known risks to potential participants before they volunteer and enroll into a clinical trial.

How are clinical research participants protected?

Clinical research is governed by the same ethical and legal codes as medical practice.  Clinical research is also federally regulated with safeguards that protect research participants, their names, and their personal health information before, during and after a clinical trial.  To ensure they are following all enforced regulations, researchers are thoroughly trained and follow carefully controlled protocols.

What will happen if I agree to participate as a subject in a clinical trial?

If your doctor determines you to be eligible for a clinical trial and you agree to participate, research staff (including your doctor) will discuss the study details and answer any questions you may have.  You and the research staff will complete informed consent paperwork to show you were fully informed of all study aspects and that you agree to participate.

What is included in the informed consent process?

Clinical trial participants have a right to be fully informed before they enroll into a trial. The FDA requires all potential clinical trial participants to be given complete information about clinical studies before they agree to participate.  This process is known as informed consent. Prior to trial enrollment, FDA regulations require research staff to inform potential clinical participants of:

  • The purpose of the research

  • The length (time) of the study 

  • The study design and which parts of the study are investigational

  • Possible risks and/or discomforts resulting from the study

  • Potential health benefits that may result from study participation  

  • Alternative treatments to be considered instead of the investigational treatment  

  • The FDA’s right to look at your study records under strict confidentiality

  • Medical treatment available if you are hurt during the study, what those treatments are and who will pay for the treatments

  • The person to contact if you have questions about the study and/or your rights as a clinical trial participant

  • Your option to quit at any time

Clinical trials sometimes go through changes or adjustments during investigation. If a study changes in a way that is different from an informed consent agreement, research staff will provide study participants with new informed consent paperwork to reflect those changes.  

What will happen once I enroll in a clinical trial?

Clinical research participants enrolled in a study will be asked to follow specific treatment plans and attend regularly scheduled clinic visits. As a clinical subject, it is very important to follow specific study instructions. Participation durations will vary depending on the study and its objectives and participants may choose to leave a study at any time.

Do I have to be a Springfield Clinic patient to participate in clinical trials?

Clinical trial participants are not required to be Springfield Clinic patients. Any interested and eligible individual may participate in a clinical trial.

Where can I find Springfield Clinic’s current and enrolling clinical trials?

A list of Springfield Clinic’s current and enrolling studies, including the participating physicians, is referenced in the current trials section.

Research Providers

The Springfield Clinic Clinical Research team is dedicated to giving providers an opportunity to contribute to their professional communities while seeking out the best treatment for their patients. Sponsor-and grant-funded research efforts are centralized into the Clinical Research department to provide a standard clinical research environment that meets all local and federal regulations.

A list of Springfield Clinic’s current and enrolling studies, including participating physicians, is referenced in the current trials section above.

All Springfield Clinic providers interested in participating as an investigator or as a sub-investigator are encouraged to contact the Clinical Research team for additional information.

Research Sponsors

Springfield Clinic’s Clinical Research department has the health care staff and investigators, patient populations and the appropriate environment required for successful trial conduct. All sponsor- and grant-funded research efforts are centralized into the Clinical Research department to provide a standard clinical research environment that meets local and federal regulations.

Clinical Research Mission Statement

The Clinical Research department’s mission is to protect human subject safety and provide quality data to assess the risks and benefits of new and upcoming therapies. Springfield Clinic and the Clinical Research Department are committed to the following core values:

  • Beneficence – Risk is minimized and proportional to the anticipated benefit.

  • Justice – Benefits and burdens are distributed fairly among different groups.

  • Respect – Subject privacies, confidentialities and full informed consents are maintained at all times.

  • Excellence and accuracy are observed with subject selection and data collection.

  • Honesty and integrity are respected with all activities.

Clinical Research Department

Springfield Clinic’s providers have participated in research for over 50 years with more than 400 clinical trials conducted to date. As a result, Springfield Clinic is continually among the top-enrolling sites in numerous multicenter clinical trials. Our program consistently meets study goals and maintains high patient retention metrics.  

Clinical Research houses a highly-trained and dedicated staff including a director, a research manager, study coordinators, a recruitment coordinator and a regulatory specialist. Personnel continually adhere to current ICH/GCP, HIPAA and CFR guidelines and maintain GCP, IATA, CITI, CCRP and/or CCRC certifications as needed. Regulatory oversight may be provided either by local (inpatient) or centralized (outpatient) Institutional Review Boards (IRBs).

The Research Committee, a sub-committee of the Board of Directors, provides oversight to all research activities performed at Springfield Clinic.

Site Overview and Credentials

Please contact us if you are interested in Springfield Clinic as a potential site for your future Phase 2, 3, 4 clinical trials.

Accreditation

Springfield Clinic is fully-accredited by the Accreditation Association for Ambulatory Health Care (AAAHC), having received the highest marks and accreditation term allowed.

Ancillary Services

Springfield Clinic has direct access to ancillary services that are required for almost any trial. State-of-the-art facilities comprise a CAP- and CLIA-certified laboratory and a research-dedicated, on-site sample processing area, a fully-digital radiology department, specialty infusion centers and an outpatient surgery center. 

Clinical Research Facilities

The Clinical Research Department is housed within a newly constructed, limited-access administrative office. Office facilities include a dedicated monitoring room with internet access and office amenities, secured regulatory document storage and locked environmentally controlled and monitored investigational product storage. 

Resources

Interested in Clinical Research at Springfield Clinic?

Please use this form to communicate with us if you are interested in clinical trials at Springfield Clinic as a patient, provider or sponsor.  If you are experiencing a medical emergency, please dial 911.


Clinical Research Contact Information

Springfield Clinic Research

900 North 1st Street, Room 1104

Springfield, IL 62702

Phone: 217.528.7541 x 24464

Fax: 217.527.4747

Email: [email protected]