Phases of Clinical Trials

Did you know there are different phases in clinical trials and on average, it takes around 10 to 15 years from the initial discovery of a potential drug to its approval? Before any new medication or treatment can become accessible to the public, it must go through a series of clinical trial phases.

In this article, we will walk you through the different phases of clinical trials, offering insights into what each phase entails and how volunteers play a crucial role.

Phase 1:

In this phase, researchers aim to understand how a new drug or treatment interacts with the human body. Volunteers in Phase 1 are usually a small group of healthy individuals. The primary focus is to determine the safety of the treatment, its proper dosage, and any potential side effects. These trails provide valuable information that helps researchers make informed decisions before moving to the next step.

Phase 2:

Once a treatment has been deemed safe in Phase 1, Phase 2 trials involve a larger group of volunteers, including individuals who have the condition the new treatment is indicated for. The goal here is to evaluate the efficacy in treating the specific condition. Researchers closely monitor the participants and collect data on the treatment’s effectiveness, potential benefits, and any side effects.

Phase 3:

Should a treatment exhibit promising outcomes in Phase 2, it progresses to Phase 3 – the final phase before potential approval by regulatory authorities such as the FDA. This phase involves an even larger group of participants. Phase 3 trials aim to validate the treatment's effectiveness, monitor side effects on a broader scale, and compare the new treatment with existing standard treatments.

Phase 4:

After regulatory approval, Phase 4 trials continue to monitor the treatment's long-term effects, benefits, and potential risks in a larger patient population. These trials provide insights into the treatment's performance in real-world settings and help identify any rare or long-term side effects that might not have been apparent in earlier phases.

Each phase is conducted following a strict protocol and guidelines, aimed at ensuring not only the efficacy and safety of the new medical interventions but also the well-being and safety of the volunteers at every step.

Your participation makes a significant difference by contributing to the development of new treatments and improving the lives of many patients around the world.

At Altasciences LA, we offer a variety of clinical trials that you may qualify for. All studies are conducted in the Los Angeles and Orange County area. To find out more, please click here to see the studies available for participation.