St Lawrence Health Clinical Research

Vax Versus Fiction: Answering Questions and Presenting the Facts about COVID-19 Vaccines

Discussion included comparing the Pfizer and Moderna vaccines, vaccination safety, phased approach to vaccine distribution, herd immunity, how to prepare to get the vaccine, and what to expect. Presented by Kylie Broughal, PA-C. Watch a recording of the webinar.

COVID-19: Fact Versus Fiction

Discussion included COVID-19 compared to the flu, the effectiveness of masks and social distancing, and COVID-19 testing. Presented by Kylie Broughal, PA-C. Watch a recording of the webinar.

COVID-19 in Rural America

Discussion included how COVID-19 can be treated, and how the pandemic is different here than in urban America. Presented by Eyal Kedar, MD. Watch a recording of the webinar.

COVID-19 and Behavioral Health/Substance Use:

- The Impact of COVID-19 on Substance Use, presented by: Emily Marquart, LMHC, CASAC; Emma Brackett, LCSW, CASAC; and Elizabeth Stiles, LPN

- Navigating COVID-19 and the Impact on Children and Families, presented by: Heather Rich, LCSW, CASAC; and Laurie Zweifel, PhD

- COVID-19 and School, presented by: Andrea Randall, Canton Central School Social Worker

- COVID-19 and Behavioral Health, presented by Tyree Smith

- St. Lawrence County COVID-19 Response: A Year in Review, presented by: Dana McGuire

Learning Together, Leading Together: Shaping Patient-Centered Research in the North Country, 3-Part Series:

Part 1: Introduction To and Examples Of Patient-Centered Outcomes Research.

Part II: Research Methods and Engagement Principles

Part III: Key Considerations for Engaged Research and the Importance of PCOR and Community Involvement

Watch This Video- What Does PCOR Mean to You? 

• Respect for persons: each person is to be treated as an autonomous individual, with emphasis on providing informed consent that ensures the comprehension of information, and voluntary participation.
• Beneficence: the participants’ well-being will always be held above all else. Trials will be accepted that minimize the risk, and maximize the benefits to participants, the health system, and the community.
• Justice: one group of people shall not be more favorably selected over others. As a rural site, we are contributing to the overall justice of clinical research, by offering trials to a non-urban population. Within our county, we offer trial opportunities to all qualifying persons, regardless of sex, race, religion, culture or background.

• RECOVER AUTO: RECOVER Clinical Trials | AUTONOMIC (recovercovid.org)
• RECOVER-VITAL: RECOVER Clinical Trials | VITAL (recovercovid.org)

 Watch this short video of CPH Rheumatologist Eyal Kedar, MD, discussing Long COVID and the clinical trial. 

• TILIA "Inpatient Viral Lung Infection"

• Cord Blood

• MT Group (MTG): Blood sample collection study with constantly changing set of available cohorts
• Partnering with Caris Life Sciences to bring oncology trials to SLH.
• Taproot under Oncology -Taproot Health – The Regulatory Real-World Data Experts 

• Triton - COPD

Watch this short video of CPH Pulmonologist Frederic Seifer, MD, discussing COPD.

Principal Investigator: Eyal Kedar, MD
Sub-Investigator: James Horrocks, PA

• ILD - Systemic Sclerosis
• Tulip (Lupus)
• M23-699 SELECT-SLE (Lupus)

Clinical research is a branch of healthcare that systematically and scientifically assesses new drugs, devices, and treatment regimens for safety and effectiveness in volunteer participants. Pharmaceutical and device companies partner with health systems like St. Lawrence Health throughout the nation and world, to execute the same research protocol in multiple locations, resulting in standardized data that can help the US Food and Drug Administration (FDA) determine if the new treatment should be approved for use in a medical setting. Each clinical trial has a strict protocol that specifies which patients can be included in a trial and outlines every detail of the study, including the schedule of study appointments, the dosage of the investigational drug, and the tests and procedures that will be completed at each appointment.

Hear it directly from one of our team members in this short video.

If you are interested in participating in a clinical trial, please reach out to the research department at (315) 261-6311 or at SLHResearch@rochesterregional.org and let us know which category you fit:

1. You are interested in one of our active studies (listed above)
2. You are not currently diagnosed with one of the conditions listed above, but you are interested in participating in a clinical trial if one does become available that fits your medical history.

Each clinical trial protocol is different, but they typically follow the same sequence of events outlined below:

1. Informed Consent: Before any study-specific treatments, tests, or procedures are performed, you will sit down with research staff to go over the informed consent form. This form is a detailed document that outlines all the information about the study and the study treatment. You will have as much time as you need to ask questions to the research staff and study physician, and to think about the decision before you choose to sign the consent form or not.
2. Screening: If you decide to sign the consent form, you will enter the screening period, where we match your health information with the criteria for the study to determine if you are a good fit to participate.
3. Treatment Period: If you are a good fit for the study and you are still interested in participating, you will enter into the treatment period, where you will attend study appointments at your physician's office, and receive study treatment as specified in the consent form. The length of your involvement varies for each study but is typically between 6 months to 2 years. The frequency of the study appointments is often monthly but can be more or less frequent depending on the study.
4. Follow-Up: After the treatment period is over, you will typically have a couple of follow-up visits, where we check up on your health and work with you to come up with a treatment plan moving forward.

Screening and treatment procedures depend on the specific study, but may include blood work, electrocardiogram, pulmonary function test, chest X-ray, etc.

Yes. Participation in a clinical trial is voluntary, and you can stop participating at any time by notifying the research team. It is helpful, but not required, to tell the research team why you have decided to stop participating.

Every study is different; however, the pharmaceutical/device company that sponsors the clinical trial often provides the study treatment at no cost to you and pays for all research-related tests and procedures. Any routine tests or procedures, which are not related to the research study, will always be the participant's responsibility.

Depending on the study, there is often compensation available to cover the costs associated with your time and travel.

Clinical research is regulated by the ethical and legal codes that apply to medical practice, in addition to clinical research-specific federal regulations that protect the rights and well-being of research participants. Clinical research trials must be approved by an Institutional Review Board (IRB), which is an independent ethics committee that ensures that the potential risks involved in participating are worth the potential benefits. During the trial, all identifying information, like your name, phone number, and address, will be kept confidential, and only shared with people directly involved in the clinical trial, or as required by law.

For more information about clinical trials, what to expect when participating, or for information about specific clinical trials being conducted throughout the world, check out https://clinicaltrials.gov/. The "For Patients and Families" section of the website may be particularly useful.