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With your help, together, we can develop new treatments that improve and advance medical care for future generations.

Clinical Trials FAQs

Clinical trials (also called clinical studies or clinical research) are paramount to new drug and treatment development. Clinical trials are research studies that test whether a new drug, treatment or device is safe and effective as treatment for a specific illness or group of people. Clinical trials can also test whether a known drug or treatment is safe and effective for new uses. Within a clinical trial, scientists are looking for critical information about the investigational drug, or device such as “Is it effective?” “Is it more effective than another established treatment?.” Clinical trials are the fastest and safest way to find treatments to improve patient care and advance medical knowledge.

Development of a new drug or treatment may take 10 + years. Clinical trials are the final stage of development for a new drug or treatment. First researchers start with an idea and develop and test it in a laboratory. Later, testing may involve animals. If the treatment has favorable results, clinical trials can begin. Clinical trials occur in multiple phases. Each phase has it’s own purpose, and with each phase, knowledge of the drug or therapy grows.

  • Phase I trials begin with a small group of participants (20-80 patients) and a therapy’s safety, side effects and safe dosage range are studied.
  • Phase II studies have a larger group of participants (100 – 300 patients) and are focused on side effects and safety, while confirming effectiveness.
  • Phase III clinical trials study an even larger group of participants (1,000 – 3,000 patients) and compare the new treatments effectiveness to common treatments while studying effectiveness and side effects.
  • Phase IV clinical trials occur after the new treatment is available in the mainstream market and study a drug’s side effects from long term use and it’s effectiveness in various populations.

Before beginning a clinical trial, the research team will provide detailed information you need to make an informed choice as to whether or not you agree to participate in the clinical trial. This process is called: Informed Consent. During the Informed Consent process you are informed of the known risks and benefits of the research study as well as details about the study. These details are found in a trial’s protocol, (or master plan). The protocol is a carefully prepared document describing the clinical trial’s purpose, length, and procedures involved. A protocol would answer trial questions such as: How many participants will be studied?, Who is eligible to participate?, What tests will be preformed?, and how often will they be preformed?, What data will be collected?, etc. During clinical trials, scientists and doctors follow strict guidelines to protect patients and to create reliable results. While volunteering in a clinical trial, you may get more tests and exams than usual to because doctors, nurses, social workers and other health care providers will be monitoring your health closely according to the plan’s protocol.

Researchers are doctors, nurses and trained research professionals who care first about a patient’s safety and well being. Clinical trial patients receive high quality care and careful medical attention. Many safety measurements are put into place during a clinical trial to protect patients, such as careful study design and Institutional Review Board (IRB) oversight. Researchers work within a strict regulatory and ethical framework provided by the FDA and ethics review boards who monitor each research trial to protect the rights and welfare of participants. Each trial follows a protocol which is approved by the IRB and each participant goes through the informed consent process before joining a clinical trial and through out the study if protocols change. Participation in a clinical trial is at no cost to the participant and may involve payment depending on the study. You can withdraw from a clinical trial at any time and for any reason.

Anyone can participate in a clinical trial. Some trials need healthy participants, other trials need patients with a particular disease or condition. Each trial has different eligibility criteria that defines who is eligible to participate in the particular study. Examples of eligibility criteria include: age, gender, stage or type of disease, medical history, and current medical conditions.

Plan ahead any questions that you may have. Write them down and bring them to the first meeting. Consider bringing a family member, friend or recording device to help you take notes. Depending on the clinical trial, your insurance may cover your treatment. You may want to talk to your insurance company or primary care provider prior to meeting with the research team.

Clinical trials are often under-enrolled and certain populations are often under-represented. Your participation in a voluntary research study is needed and appreciated. With your help, together, we can make a difference! Together we can move science forward and discover necessary breakthroughs to cure disease. Join a larger community while taking an active role in your own healthcare. While in a research study, you may receive better care and more attention from a dedicated research staff while receiving cutting-edge treatments. Your participation helps to develop new treatments that improve and advance medical care for future generations.

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If you are interested in joining a clinical trial, please fill out the confidential form below to be notified when clinical research that interests you becomes available.