What are the different phases & types of clinical trials?

Clinical trials are the best way to test a new treatment or drug and find out if it is safe and effective. Usually, clinical trials are aimed at evaluating an intervention: behavioral, medical or surgical. Without them, there won’t be new advancements in medicine, better treatments or even cures for illnesses.

 

Clinical studies, on the other hand, are observational and can help to identify new possibilities for clinical trials. In such a setting, researchers compare changes within a group of volunteers over time to learn more about the effects of different lifestyles on areas such as cognitive health.

 

There are different phases of clinical trials and before the FDA can approve a drug, usually Phase I, II, and III trials need to be conducted in order to learn more about the new treatment, possible side effects, and the correct dosage.

 

• Phase I: This is an experimental treatment on a small number of people (usually 20-50) to learn more about a drug’s side effects and safety and also find the correct dosage.

• Phase II: This phase is all about effectiveness and aims to find out if the new drug or treatment works in people with a certain health condition.

• Phase III: This is a trial on a larger scale - with about 500-3,000 people involved and can last several years. The aim of this phase is to collect more information on effectiveness and safety while studying different demographics and populations with different dosages, while also combining the drug with other drugs. If the result of Phase III is positive, the FDA usually agrees to approve the drug.

• Phase IV: This phase happens after the FDA has approved the drug and aims to further monitor the safety and effectiveness of the new drug in a large, diverse population. 

 

When considering being part of a clinical study, you should know what type of study you might participate in:

 

• Prevention trials: As the name suggests, prevention trials are looking into preventing a disease. Usually, researchers are looking for people who have never had the disease or for people who want to prevent the disease from returning. Lifestyle changes, vaccines, or new drugs are approaches to this type of trial study.

• Quality of life trial: A quality of life trial approaches people with chronic conditions and aims to improve their comfort and quality of life in different ways.

• Treatment trials: In a treatment trial, new treatments, new approaches to surgery, or a new combination of drugs are tested.

• Screening trials are testing new ways to detect health conditions or diseases.

• Behavioral trials look into how behavioral changes can improve health.

• Diagnostic trials: Diagnostic trials compare tests or procedures for diagnosing a specific disease or health condition.