A clinical trial helps us learn how an investigational medicine works in the body. Clinical trials must be reviewed by a regulatory agency. In the United States, it's the Food and Drug Administration (FDA). In Europe, it's the European Medicines Agency (EMA). Agencies vary by region. They decide whether to approve the investigational medicine for doctors to prescribe.

The first step is discovering and developing a new investigational medicine to study. After that, clinical trials show if it is safe and effective and provide information on any side effects. Sometimes, researchers compare the potential medicine to a placebo. The placebo looks and is administered like the potential medicine but has no active ingredients. The new medicine may also be compared to a standard medicine that is already approved and used for treatment.

A placebo looks like the investigational medicine being studied but has no active ingredients. Results for those who take the potential medicine are compared to results for those who take the placebo. Researchers can tell whether a potential medicine is effective by understanding if it works better than placebo.

Anyone can search for clinical trials and ways to join. Some trials are for people with diseases. Some are for healthy volunteers. Healthy volunteers are people with no known major health concerns. Researchers want people who meet certain eligibility criteria. These vary based on the trial. They may include diagnosis, age, gender, ethnicity, medications they are taking, medical history and more.

Your primary doctor, as well as clinical trial doctors and staff, can help you understand the requirements.

To find a Pittsburgh Research Institute clinical trial, contact us at pghtrials.com or call us at 412-223-6334

Healthy volunteers do not have the medical condition or disease being studied. Scientists look at information from healthy volunteers without the condition and patient volunteers who do have the condition. This helps us better understand the investigational medicine or even the disease itself.

If you are eligible, clinical staff will ask you to sign an Informed Consent document. “Informed Consent” means you learn about the study before you decide to join. The document has all the information you need to know, including the study purpose, length of time, procedures, potential risks and potential benefits.

The study doctor may then run tests and review your medical history. Ask the study doctor and team as many questions as needed.

Generally, during a treatment period, study participants may receive one of the following:

• The investigational medicine (the medicine being studied);

• A placebo (looks like the medicine being studied but has no active ingredients);

• A standard medicine already approved for the disease.

Throughout the study, your health and well-being are monitored. This may happen at the clinical trial site, through telemedicine or during home visits. Ask about these visits as you consider enrolling.

It is possible that your condition could remain the same, improve or get worse.

Nothing else is usually needed or expected from you. The clinical trial staff may give you contact information in case you have questions. You may also be asked about your experiences with the clinical trial treatment.

Pittsburgh Research Institute supports data transparency that advances science and medicine and is committed to sharing data from our clinical research and clinical trials in a responsible manner. As part of our commitment to data transparency, we make the results from our clinical trials available in an easy-to-understand format. These are called Plain Language Summaries, and they summarize the results from a clinical trial in everyday language. They include information about the reason for the trial and the results.

The duration of a clinical trial depends on the goals of that trial. Staff will tell you how long a trial will take and how many site visits to expect.

All clinical trials are approved by an institutional review board (IRB), which may also be known as an Ethics Committee (EC). IRBs are formal committees. They protect you by making sure research is ethical. These boards include doctors, researchers and other members of the community.

When a trial is approved by the IRB, the study organizers must follow a plan called a protocol. A protocol describes exactly what happens during the study. Researchers stick to the protocol to protect everyone. You will know the full details of the protocol before joining a clinical trial. You will also have the chance to ask questions.

The Informed Consent document talks about risks involved in participation. Before starting a clinical trial, you must sign the document. Signing it means you agree to participate in the research study. The trial staff will walk you through the study schedule and design. Ask questions so you are comfortable moving forward.

Clinical trials are 100% voluntary. You can stop at any time.