Clinical trials ensure the new drug is safe to move forward into further testing in larger groups of people. They test new cancer treatments for safety and determine the best dose for patients and are the first step in bringing innovative therapies to cancer patients who may not have other treatment options. A phase 1 clinical trial is the first step in testing a new drug or treatment in humans. Here's a simple breakdown:

1. Purpose: The main goal is to evaluate the safety of the new drug or treatment. Researchers want to figure out the right dose, how the drug is absorbed, and whether it causes any side effects.
2. Who participates? A small group of healthy volunteers (usually 20-100 people) or patients with the condition the drug is meant to treat may take part. The focus is not necessarily on how well the drug works, but on how it affects the body.
3. What happens? Participants are closely monitored in Intermountain Cancer Center’s controlled environment. They may stay there while the drug is given, and doctors watch for any adverse reactions.
4. Length: These trials can last from a few days to several weeks or years, depending on the type of treatment and how well a patient responds. Participants may need to come back for follow-up visits.

Goals of phase 1 clinical trials

These trials focus mainly on safety and dosage rather than testing how well the treatment works; however, there are many patients whose disease will respond to Phase I Trial therapies. The primary goals of conducting phase 1 clinical trials are:

• To evaluate the safety of a new drug or treatment and identify any potential side effects.
• To determine the best dose of the treatment that is both safe and effective without causing harmful effects.
• To understand how the drug is absorbed, distributed, metabolized, and eliminated by the body.
• To study the drug's effect on the body and its mechanism of action.

While phase 1 trials may offer direct benefits benefits, they also carry risks. Here are some benefits and risks of participating in a phase 1 clinical trial for you to consider:

Benefits

• Access to new treatments: Participants are among the first to try a new drug or therapy, which may not be available to the general public for several years if proven effective.
• Close medical attention: Participants are monitored very carefully by medical professionals throughout the trial, often receiving a higher level of care than in regular healthcare.
• Contributing to science: Participants help researchers learn more about new treatments, which can potentially help others in the future.

Risks

• Unknown side effects: Since the drug is being tested on humans for the first time, the side effects are largely unknown and could be serious.
• No guaranteed benefit: There’s no assurance that the treatment will help or even treat the condition.
• Time commitment: Participation often requires regular visits and follow-ups, which can be time-consuming. The trial sponsor may offer travel reimbursement or support for transportation.