Zenith

Clinical Research

About us

Zenith Clinical Research is a research site that is partnered with Primary Medical Physicians and specializes in offering advanced therapies and diagnostic tests to our patient population through clinical research.

what do we do?

Clinical research is the comprehensive study of the safety and effectiveness of the most promising advances in patient care. Clinical research is different than laboratory research. It involves people who volunteer to help us better understand medicine and health. Lab research generally does not involve people — although it helps us learn which new ideas may help people.

FAQs

What is a clinical trial?

A clinical trial is an experiment conducted by medical professionals to test newly developed medications or treatments on a group of volunteers. The objective of the study is to determine the safety and effectiveness of these innovative treatments. The study is led by qualified physicians selected by pharmaceutical and biotechnological companies. Participants in the clinical trial have the opportunity to try new treatments that are not yet available to the general public while receiving close monitoring and evaluation.

Who is eligible to take part in a clinical trial?

Clinical trials have specific rules that determine who qualifies to participate. These guidelines consider factors like age, gender, disease type and stage, previous treatment history, and other medical conditions. These factors are separated into “inclusion” and “exclusion” criteria, and those who meet the inclusion criteria are eligible to participate. Some trials require participants with certain illnesses or conditions, while others need healthy individuals. The purpose of these criteria is to identify suitable participants, ensure their safety, and gather relevant information for research.

Is the information kept confidential?

During a clinical trial, the investigator and research team usually have access to personal information. In certain situations, the Institutional Review Board (IRB), sponsor, and contract research organization may also have access to this information. Prior to participating in the trial, volunteers are informed of this in the consent form they sign. As the trial progresses, the researchers share their results with medical journals, scientific meetings, and government agencies. Volunteers who participate in clinical trials help to develop new medical therapies that may offer improved treatment options and even cures for life-threatening and chronic illnesses.

What is the process of a clinical trial?

After becoming an eligible participant, volunteers are allocated to particular research groups. They are then given various treatments. Some volunteers from a group may receive a new treatment or investigational drug, whereas others may receive a placebo or a pre-existing treatment. This method enables medical professionals and researchers to impartially monitor volunteers throughout the study. Regardless of the treatment, all volunteers receive the same medical care and attention.

What are the benefits of being a volunteer?

Volunteering for a clinical trial can be advantageous. Those who participate actively contribute to the advancement of healthcare treatments. Additionally, they get the opportunity to try out new research treatments before they are commonly accessible, and receive essential medical care at the healthcare centers during the trial.

What are the risks in being a volunteer?

Clinical trials require oversight by the government and an IRB to oversee biomedical studies on human subjects. The safety and welfare of the participants take priority to ensure that the benefits outweigh the risks. Nonetheless, there are some potential risks involved in clinical trials, including the possibility of severe, life-threatening side effects from experimental treatments, a lack of efficacy from the experimental treatment, and uncertain treatment timelines or requirements that may necessitate extra visits, treatments, hospital stays, or dosage regulations.

phases of Clinical trials

Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions. 

Phase I

Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.

Phase II

The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III

The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. 

Phase IV

Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.

How to enroll?

Please answers the following questions and our staff contact back to you soon.

Modern medical advances have helped millions of people live longer, healthier lives. We owe these improvements to decades of investment in medical research.

Ike Shelton

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Reach out with your questions, concerns and challenges. Or just to say hi. We’ll be happy to chat and help.