Clinical trials

Clinical trials are research studies involving human volunteers that test new medical treatments, devices or diagnostic tools to determine if they are safe and effective and to compare them to the current standard of care. When researchers can show that a new medical treatment, drug or device is generally safe and effective, they can be offered to people through a clinical trial. People who have been diagnosed with an illness or disease may participate to gain access to new and promising treatments that are not yet available to the general public. Healthy volunteers may also take part in clinical trials to advance medical knowledge and serve to compare against people with specific diseases.

There are 4 phases to most clinical trials:

• Phase I – New treatments are tested for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
• Phase II – Phase I was successful and now the group size for participants can be expanded to 100-300 or so volunteers.
• Phase III – An even bigger, and more diverse group of people are allowed to participate in the trial. This phase is often the step right before a new treatment is submitted for government approval.
• Phase IV – The FDA approves the treatment and it is made available to the public, but researchers continue to track its safety, benefits and best use.

Roper St. Francis Healthcare typically offers Phase III and IV trials. 

You will always receive the established standard of care treatment for your specific medical condition. If you participate in a clinical trial, you may receive a new medical intervention in addition to your standard care. You may receive the newest available treatment or receive extra attention from the clinical research staff. There are also trials that simply collect information to advance science and help future patients, in which case your regular medical care would not change while participating. 

Information collected from clinical trials can advance science and help to improve future medical care. Participating in a clinical trial may be beneficial for patients with specific medical conditions that have not improved under standard treatments, as trials sometimes offer treatment options that are not yet available outside of the trial. However, there is no guarantee that participants will benefit from a trial.

Clinical trial treatments and devices can cause side effects or have other health risks, and researchers may not yet know all of the risks. Because these treatments are so new or being used in a new way, it can be hard to predict all of the risks ahead of time. Your doctor will discuss the potential risks before you participate as part of the informed consent process and will notify you of any changes in risk during the trial. 

Your eligibility for a clinical trial depends on many factors. It can depend on things like your age and gender, lifestyle choices, overall health, medical history, the specific type and severity of disease you have, and how well you meet other criteria the researchers are studying. Your doctor and the study staff will assess your health and the requirements of the trial to determine if you are able to participate. Sometimes, additional tests are needed to determine if you are eligible.

Informed consent is the process by which researchers communicate all the details a patient needs to make an informed decision about participating in a clinical trial. Information about the trial is typically provided in a document called an informed consent form, which patients are asked to sign if they choose to participate. Details in the consent form will usually include the purpose of the clinical trial, how long it’s expected to last, what tests or procedures will be done, the potential risks and benefits, cost and payment information, privacy protections, and who to contact for more information. 

The informed consent process also allows time for patients to ask and receive answers to any questions they may have and includes being informed of any changes during the trial that may impact their decision to continue participating. Even if you sign an informed consent form agreeing to take part, participation in clinical trials is always voluntary, and you can change your mind before starting or at any time during the trial. 

If you are thinking about participating in a clinical trial, you should be given points of contact who can answer any questions you may have. You may talk with your regular doctor, the study doctor or study staff. Consider asking:

• Will I have to pay for any part of the trial?
• Will my health insurance cover my regular medical costs while I participate in the trial?
• What kind of therapies, procedures or tests will I have during the trial?
• What are my other options if I don’t participate in the trial?
• Who will oversee my care?
• What are the long and short-term benefits/risks of participating?
• How could being in this study affect my daily life?
• Who are the researchers conducting the trial?
• Who reviewed and approved this clinical trial?
• How will my safety be monitored and protected if I participate?
• Will I be told the results of the study?