How many phases are there in clinical trials

Clinical trials testing new treatments are divided into different stages, called phases. The earliest phase trials may look at whether a drug is safe or the side effects it causes. Later phase trials aim to test whether a new treatment is better than existing treatments.

There are 3 main phases of clinical trials — phases 1 to 3. Phase 1 trials are the earliest phase trials and phase 3 are later phase trials. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed.

Some trials are randomised. This means the people taking part are put into one of the treatment groups at random. Doing this means the results are more reliable. Skip to main content. Phases of clinical trials. This page is about the different phases of clinical trials. It has information about What are trial phases? Trial phases at a glance Phase 0 trials Phase 1 trials Phase 2 trials Phase 3 trials Phase 4 trials Trials covering more than one phase What are trial phases? Trial phases at a glance Phase Number of people taking part Cancer type Main aims of trial Is it randomised?

But your doctor might ask if you would like to join a phase 0 study. These studies aim to find out if a drug behaves in the way researchers expect it to from their laboratory studies.

Phase 0 studies usually only involve a small number of people and they only have a very small dose of a drug. The dose of the drug is too small to treat your cancer, but you are also less likely to have side effects. You might have extra scans and give extra samples of blood and cancer tissue biopsies to help the researchers work out what is happening. Phase 1 is sometimes written as phase I. They are usually small trials, recruiting only a few patients.

The trial may be open to people with any type of advanced cancer, usually those who have already had all other available treatments. Patients are recruited very slowly onto phase 1 trials. So even though they don't recruit many people, they can take a long time to complete. They are often dose escalation studies. These are all ways to learn how well the treatment works.

A Phase II clinical trial lasts about 2 years. Volunteers sometimes receive different treatments. For example, a phase II trial could have 2 groups. Group 1 — People who receive the usual treatment for the condition. This is also called the standard treatment. It is the best treatment known. Or a phase II clinical trial could have 3 groups. Volunteers in each group get a different dose of the treatment doctors are studying. If the phase II clinical trial shows the treatment works and is as safe as the regular treatment, doctors can do a phase III trial.

Doctors use a computer program to put volunteers into different groups. The computer does this at random, which means by chance. Each volunteer has an equal chance of going in any of the groups.

The name for this process is "randomization. Using a computer to put volunteers in groups keeps the research staff from possibly changing the clinical trial results. They might do this if they chose who went in which group. For example, they might think a certain volunteer would benefit from the new treatment. So they might put that person in the new-treatment group. But this could change the clinical trial results. Randomization helps avoid this. It is very important to use randomization when a clinical trial compares 2 treatments or more.

A phase III clinical trial tests a treatment that worked well for volunteers in a phase II clinical trial. Doctors use phase III to compare the new treatment with the standard treatment. They want to know if the new treatment is better, has fewer side effects, or both. So they put volunteers in different groups. The volunteers in each group get a different treatment. Phase III clinical trials can take many years. They may have several thousand volunteers.

These must include men, women, and people of different ages and ethnic groups, if possible. This helps doctors learn how the treatment works in different people.

If a phase III clinical trial shows the treatment works well, doctors might begin using it with people outside the clinical trial. For example, if they learn that a certain amount of exercise lowers your cancer risk, they publish a report. During phase one, a small group of willing participants who would be ideal patients for your product will use it and report their results back to you. These participants will be monitored closely for any signs of adverse effects or symptoms you will need to report.

If your product is a medication, you will have established the appropriate dosage amount in phase one. In phase three, you will test your product in more depth on much larger groups of people. At this stage of the FDA clinical trials, your product has received FDA approval, and your marketing campaigns are underway.

Studies performed in phase 4 focus on discovering the long-term effects of your product and gathering more data on how it interacts with other drugs if your product is a medication. Paper-based systems are outdated and inefficient. You are more likely to lose or misplace critical documents with these types of systems. Download our free guide to learn the 12 questions you need to ask before investing in an eQMS for your company.

Learn from the best in quality. Download your guide now.