Phase 1 of clinical trials are the first step in the development of human treatments. They are designed to test a new drug's safety, and they're for people who have a serious illness and no other treatment options.
Cohort Size
Typically this stage of clinical trials has around 20-80 volunteers participate. The study may last for about eight weeks and participants will be given either one or two doses of the drug in different phases. The first phase is called the placebo condition with no medication, followed by four conditions:
- 1. Placebo (no medication)
- 2. Placebo + 1 dose
- 3. Placebo + 2 doses
- 4. Double-blinded placebo control
Enrollment
You can't enroll in these studies yourself. You must be invited by a doctor or researcher to participate, and then you'll meet certain medical requirements before being enrolled in the study.
The first step to participating in a clinical trial is to make an appointment with your healthcare provider, who will check your medical history and assess any potential health conditions that may interfere with the clinical trial process. If everything checks out, they'll send you an invitation letter explaining what's involved with the phase 1 clinical trials programs.
To participate in the study, you must agree to follow the study's requirements. This includes keeping all appointments and taking all required medications as directed by your physician or pharmacist.
You also should not have any medical conditions that would limit the study's ability to provide accurate results for participants such as heart disease or high blood pressure (hypertension)
When researchers evaluate the safety of new therapies.
Phase 1 clinical trials are designed to evaluate the safety of new therapies and not their effectiveness. The goal is to find out if there are any harmful side effects that may occur when you take a drug. This information will help researchers determine whether or not your body can handle the medication without problems.
In some cases, phase 1 clinical trials can last several months or years. You'll often see patients who have been diagnosed with cancer being given certain medications in these phases due to their condition being highly invasive or deadly: they need to know if they're going through treatment safely before moving forward with more complex treatments like surgery and chemotherapy that may cause serious damage if administered incorrectly.
The benefits and side effects of a drug become evident.
Although phase 1 clinical trials are often thought of as a "proof of concept" for drugs, they can also be used to determine the safety and efficacy of new compounds. In phase 1 studies, researchers test a drug's ability to safely and effectively treat patients with certain diseases or conditions.
Phase 1 studies may involve testing only one dose or level of medication (the "single arm" design), or multiple doses and levels (the "double-blinded" design). The goal is to determine whether the potential benefit outweighs any possible side effects; if not, then researchers will need to look for better ways of doing things before moving forward with further testing or approval in larger populations.