Clinical Trials

Jefferson conducts cutting edge research to advance science and medical treatments globally. By participating in clinical research you are investing in yourself, your community and the future of research. It is our partnerships with our volunteers that help create breakthroughs and further medical knowledge and treatments. We pride ourselves on creating a research environment based on respect, trust and compassion between our teams and volunteers and work together as one to improve the outcomes of many.

A person may participate because they want to take a more active role in their health, or because they are interested in gaining access to new therapies and treatments before they are widely available. Volunteers for clinical trials may include healthy individuals from the communities Jefferson serves, as well as people with known health problems.

There are a variety of clinical trials, both for cancer and non-cancer health matters. These can include prevention trials, quality of life trials, screening trials, diagnostic trials and therapeutic trials, among others.

Remember, taking part or not taking part in a clinical trial is your choice, as clinical trials are all voluntary. It is a good idea to look at all of the treatment options available with your doctor, other healthcare team members and your family. This will help you decide if participating in a clinical trial is good for you.

Types of Clinical Trials at Jefferson Health:

Clinical Trial Phases

Clinical trials are performed in the following phases.

  • Phase I
    Tests a new therapy for the first time in a small group of people to determine if it is safe, find the right dose, and learn about side effects.

  • Phase II
    Involves more people to determine how well the new therapy treats a disease and whether the treatment is safe.

  • Phase III
    Broadens the study to include large groups of people to determine if the new therapy works well, if it has side effects, and how it compares to other therapies.

  • Phase IV
    Once the treatment is approved by the U.S. Food and Drug Administration (FDA), these studies evaluate the effects of new drugs and treatments over a long period of time in large groups. They are often focused on particular groups such as people of specific ages, genders, or races, or people who are taking other medications or have other diseases.

Frequently Asked Questions

By participating in clinical research you may provide important scientific information for developing new disease treatments and further medical knowledge.

There may be risks with any clinical study. The risks and benefits are reviewed in detail in the informed consent process. You are encouraged to ask questions throughout the consenting process and while you are in the study. There are no guarantees that the drug or device being studied will be effective. The principal investigator or study coordinator will explain the potential risks and the potential benefits before you sign the consent form and join the study

A human subject is a volunteer participant who is or becomes involved in a research study. A subject can be either someone who is healthy or someone with a particular medical condition.

A clinical trial is a research study designed to test the safety and/or effectiveness of drugs, devices, treatments or preventive measures in humans.

Informed consent is required for participation in all research studies involving human subjects. Individuals are given information about what is involved in the study, including possible benefits and risks. Prospective study participants are encouraged to ask as many questions as they like. Below are some examples of the type of questions to consider before signing a consent form.

  • What is the purpose of the study?
  • What type of tests and treatments are involved?
  • Are there any costs involved?
  • What are potential side effects?
  • How could this affect my daily life?
  • What is involved and for how long?
  • What other choices do I have? What are their advantages and disadvantages?

Researchers must follow the same ethical and legal codes they follow during routine care. Each research study and clinical trial is reviewed and approved by an Institutional Review Board (IRB) to ensure Human Subjects Protection. Potential risks and benefits of the study will be detailed in the Informed Consent of the study and reviewed with you by your study team.

A blinded study is done so that neither the researchers' nor the participants' expectations about the experimental treatment can influence the study results.

In a single-blinded study participants do not know whether they are in an experimental group or a control group. In a double-blinded study, neither the participants nor the researchers know which participants are in a group.

In a controlled study, participants are assigned either to an experimental group or to a control group. Participants in the control group are used as a standard for comparison. For example, a study may have two groups, an "experimental group" and a "control group." The experimental group is given the experimental treatment under study, while the control group may be given either the standard treatment for the illness or a placebo. At the end of the study, the results of the two groups are compared.

 

Research subjects are randomized in clinical trials so that bias does not weaken the study results. Bias refers to human choices, beliefs or any other factor besides those being studied that can affect a clinical trial's results. If physicians or participants themselves choose the group, assignments might be personally influenced and therefore unevenly slanted toward one side or the other.

 

Study participants in the experimental group receive the drug, device, treatment or intervention under study.

 

A treatment trial tests new treatments (new drug, approaches to surgery or radiation therapy, new combinations of treatments or methods may also be tested). A prevention trial tests new approaches-such as medicines, vitamins, minerals or other supplements-that doctors believe may lower the risk of a condition.

 

A placebo is an inactive agent used for testing against the active drug. The results of the active compound are compared with the placebo to better understand the actions of the active drug.

Yes. Participation in a research study is voluntary. You may leave at any time for any reason. The principal investigator can withdraw you from the study if new potential risks are reported and if you are no longer benefiting from the treatment.

All research participants receive a copy of their signed consent form for their own records and contact information is in the form.

With a team of globally renowned doctors and researchers we are here to partner with you for better outcomes tomorrow.