Clinical Trials FAQs

Clinical trials are research studies done to find out if a treatment can improve people’s health. A treatment can be a drug, medical device, medical procedure, or a change in a person’s behavior such as diet or exercise. People who take part in clinical trials are volunteers. They may also be called “participants” or “subjects.”

Every clinical trial must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. Once the trial is approved by the IRB, the organizers of the study must follow a careful plan, called a protocol, that describes exactly what will happen during the study.  You will know the full details of the protocol prior to joining any clinical trial.

Every medication and treatment has been previously tested on humans and been declared safe for further testing.

You don’t always have to previously be diagnosed, but for some trials a previous diagnosis is required.

All clinical trials have guidelines spelling out who can participate. These are called eligibility criteria. The factors that allow you to participate in a clinical trial can include age, gender, the type and stage of your disease, previous treatment history, and other medical conditions. Following eligibility criteria helps us keep you safe and ensures that researchers learn the information they need.

Yes, you can. Most of the time, we require you to be on a stable dose of your prescribed medication during your trial participation.

A placebo is a pill or other substance that has no therapeutic effect. If a placebo is part of the trial you’re considering, you will be fully informed of that fact ahead of time. You would only be considered for such a trial when it’s safe and medically appropriate.

Informed consent is the process of learning about the clinical trial before you decide to take part in it. The Sharlin Health Research Team will explain the trial’s purpose, how long it will take, what will happen, all potential risks and benefits, and information on the privacy of your medical records.

If you want to participate, you will sign a consent form that details all of the information that has been discussed with the research team. You will be able to take that form home and refer to it at any time. Even though you have signed the consent form, you still have the right to leave the study at any time and for any reason.

Informed consent continues throughout the trial. This will give the research team an opportunity to update you on the progress of the trial as well as any side effects or other risks that have been identified.

There are possible risks, such as adverse events or side effects, to consider when participating in any clinical trial. Participants are informed of known risks or side effects before starting the trial. Risks also are explained in the informed consent document. Make sure you fully understand them. There is always the possibility of unknown risk. If any new side effects or risks are discovered during the trial, you will be informed.

You do not have to pay. SHNRC may compensate study participants for their time and, in some instances, for the inconvenience of a procedure. Compensation varies for each clinical trial. Compensation of over $600 is reportable to the IRS and requires a Form 1099.

Yes. Clinical trial participants have the right to change their minds at any time even after they have started the clinical trial or at any time during the trial. It is important to contact the clinical trial site and inform the research team of a decision to stop participating to make sure steps are taken to safely transition a participant back to their previous care.

The health of millions of people has been improved because of advances in medical care, made possible by clinical trial participants. People choose to participate in clinical trials for a variety of reasons, including the chance to play a more active role in their own health care, gain access to new medical treatments before they are available to the wider public, and help others by contributing to the future of medical science.

It depends on the trial; they can vary from days to a number of months or even years. You will be told the expected length of the trial before you start. This information is discussed with you during the informed consent process.