Our Research Review Committee is comprised of Summit Health physicians and staff who manage all medical clinical trials, determine the scientific/ethical merits, and identify the potential impact of clinical research on patients.
What is Clinical Research?
Also known as clinical trials, clinical research involves patients who might benefit from new treatments that are not yet available. Research physicians use clinical research to test a medication, device, treatment approach, or medication dose. All research includes a panel of experts, also known as physician investigators, who decide how best to use the new treatment. The investigators also identify the types of patients who are likely to benefit most from the treatment. To be eligible for a clinical trial, the patients must fit certain criteria.
During a clinical trial, the researchers track and make note of all the changes (data) subjects experience as a result of the treatment they are given. The data are then used to make decisions about whether to use the medication, device, or treatment for a wide range of patients.
People who participate in medical research and clinical trials are volunteers.
In general, clinical research helps determine whether:
- A new medication, device, treatment, or dose is safe and effective for a specific type of patient
- An already marketed medication or device can be used for a different disease or condition than the one for which it was originally intended
- A new medication, device, or treatment is more effective than previous treatments for a disease or condition
Medical clinical trials also sometimes compare more than one medication, device, or treatment to determine which is the most effective.
What to Expect
Better research helps researchers and practitioners understand a disease, condition, or disability as well as examine and develop ways to prevent, diagnose, treat and improve quality of life.
It is the foundation of advances in healthcare processes, treatments, and technologies.
Clinical research helps determine whether treatments are safe and effective. It is used to help improve quality of life for people who are experiencing temporary as well as ongoing (chronic) illness. Clinical research can give participants hope for overcoming a disease or condition.
Types of Clinical Research Include:
- Natural history studies to gather information about health and disease
- Screening trials to identify how to detect a disease or condition
- Diagnostic trials to determine best tests or procedures for diagnoses
- Treatment trials that include medication(s), surgery, procedures, and other therapies
- Prevention trials, including medication, vaccines, and lifestyle changes to help prevent disease from occurring and recurring
- Quality of life (or supportive care) trials to identify ways to improve quality of life for people with chronic illness
About Clinical Research
All clinical research in the United States is conducted with the review and approval of an accredited, independent review board (IRB) comprised of physicians, and statisticians. The IRB reviews each clinical trial before and during research to ensure the trial is ethical, participants’ rights are protected, and that risks are minimal.
Clinical research involves a plan known as a protocol that:
- Identifies the purpose of the trial
- Outlines who can participate (eligibility)
- Defines how long the study will last (study duration) and its phases
- Describes the treatments, including frequency and dosages of medication
- Gives details about tests and procedures
- Identifies the researchers, including a principal investigator and coinvestigator(s)
- Specifies information the researchers will gather
- Suggests whether the data will be published
Informed consent is an important part of the clinical research process. It helps people decide whether to participate in a clinical trial. During informed consent, researchers explain details of the study, including its purpose, length, treatments involved, required tests and procedures, and benefits and risks. Participants also are given contact information so that participants know whom to call to get answers to their questions. Once a trial is underway, participants continue receiving information about the trial as part of informed consent.
All participants must sign a document of informed consent to engage in clinical research.
Informed consent is not a contract. All participants for clinical research are considered volunteers who are free deny treatments, test, or procedures as well as withdraw from the study. In some cases, however, denying treatments, tests, or procedures can mean being unable to complete (or becoming ineligible for) the trial.
Our Research Team
Clinical researchers learn about disease processes when they compare healthy volunteers with patient groups in a clinical trial.
View Our SpecialistsEnrolling in Clinical Research
Before enrolling in clinical research, potential participants must qualify for it.
If you are considering enrolling in clinical research, you should consider:
- Risks, including:
- Unpleasant side effects it might cause
- Potential complications that require additional medical attention
- Visits to the study site and time it takes from your other activities
- The need for additional treatments, test, and hospital stays
- Possible costs to you for traveling to the study site
- Benefits, including:
- Having an active role in your health care
- Access to new treatments before they are available to others
- Receiving medical care and attention from doctors and other health care practitioners
- Contributing to the health and well-being of others
Once a new treatment, device, or intervention is proven safe and effective in clinical research, it can become a standard of medical practice.
Michelle Mackenzie, RN, OCN, CCRC
Clinical Research, Oncology and Hematology
Kelly M. Ritter, LPN, CCRC
Clinical ResearchFor more information regarding our oncology trials, please call 973-436-1755 or email
Michelle Mackenzie, RN, OCN, CRC at mmackenzie@summithealth.com
Kelly Ritter, LPN, CCRC at kritter@summithealth.com
Current Active Trials - Last Updated January 16, 2026
In addition to the below trials, Summit Health has access to the Tempus TIME Trial™ Program which seeks to rapidly match patients to targeted clinical trials.
| Service | Type | Principal Investigator | Title | Description |
|---|---|---|---|---|
| Cancer Services | Breast | Dr. Winnie Polen | NCT03463954 | Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm |
| Cancer Services | Breast | Dr. Steven Papish | Early Breast Cancer with High Risk of Recurrence | Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT) |
| Cancer Services | Breast | Dr. Steven Papish | Hormone + HER2 - Adjuvant Breast Cancer | A phase IIIb study to characterize the efficacy and safety of Adjuvant ribociclib plus endocrine therapy in a close-to-clinical practice patient population with HR+ HER2− early breast cancer (Adjuvant WIDER) |
| Cancer Services | Breast | TNBC w/o Pathological Complete Response at Surgery Please be aware patients must complete RT prior to enrolling and NO doses of Pembro can be given in the adjuvant setting until randomized | A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery | |
| Cancer Services | Breast | Breast Cancer Survivors - Cognitive Impairment | NRG-CC011: Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial | |
| Cancer Services | Breast | Dr. Steven Papish | HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER | A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Inavolisib Plus A Cdk4/6 Inhibitor And Letrozole Versus Placebo Plus A Cdk4/6 Inhibitor And Letrozole In Patients With Endocrine-Sensitive Pik3ca-Mutated, Hormone Receptor-Positive, Her2-Negative Advanced Breast Cancer |
| Cancer Services | Breast | Dr. Steven Papish | ER+HER2- metastatic breast cancer | A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE) |
| Cancer Services | Breast | Dr. Steven Papish | Locally advanced, unresectable or metastatic Breast Cancer | A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer |
| Cancer Services | Breast | Dr. Steven Papish | Breast Cancer | GEMINI-BREAST: Evaluating Minimal Residual Disease (MRD) through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies |
| Cancer Services | Breast | Dr. Steven Papish | TNBC | A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD(L)1 therapy based on PD-L1 negative disease |
| Cancer Services | Gastrointestinal | ON HOLD Stage IIB, IIC, or Stage III colon adenocarcinoma PI | NRG-GI008: Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA) | |
| Cancer Services | Gastrointestinal | Dr. Jeanette Kovtun | First-Line Metastatic Gastric or GE Junction | A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma |
| Cancer Services | Genitourinary Oncology | Dr. Glen Gejerman | Prostate Cancer | Randomized trial of Barrigel® to increase distance between the rectum and prostate bed to decrease rectal dose in patients receiving moderately hypofractionated radiation therapy who have had recurrence of prostate cancer after prostatectomy. |
| Cancer Services | Hematology | Dr. Steven Papish | R/R B-Cell Malignancies | A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies |
| Cancer Services | Thoracic | Dr. Lalitha Anand | mNSCLC w/EGRFm | AstraZeneca, D516KC00001, A Phase III, Open Label, Sponsor-Blind, Randomized Study of Dato DXd With or Without Osimertinib Versus Platinum-Based Doublet Chemotherapy for Patients with EGFR-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed on Prior Osimertinib Treatment (TROPION-Lung15), 284004 |
| Cancer Services | Thoracic | Dr. Charles Kim | 1st Line NSCLC | A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer |