What is a Phase 4 Clinical Trial?

Following the completion of Phase 3, a drug is approved (or not approved) by the US Food and Drug Administration (FDA) for use by specific patients. Phase 4 may only begin if the drug is approved.
Phase IV clinical trials study the side effects caused over time by a new treatment/drug after it has been approved and is on the market. These clinical trials look for side effects that were not seen in the earlier phases of clinical trials and may also study how well a new treatment works over a long time. Phase IV clinical trials may include thousands of participants. Also called phase IV clinical trial and post-marketing surveillance trial.

Understanding Clinical Trials Phases

Clinical trials follow a specific timeline, from early, small-scale, phase 1 clinical studies to late-stage, large-scale, phase 3 studies. Although there are many clinical trial phases involved in developing new treatments, clinical research is a part of drug development that involves human participants.

Purpose of Phase 4 Clinical Trials

By the time phase IV studies begin, the treatment has already gone through 3 to 4 phases of clinical research. Although researchers have already studied the treatment extensively and secured FDA approval, they usually still have questions about the long-term safety and effectiveness. For example, does the treatment produce rare side effects that have not been recorded yet? Do some side effects only come up after a participant has taken the treatment for a long period? Does the treatment’s effectiveness wane over time? How well does the treatment work when used along with other treatments?

Pharmaceutical companies may also use phase IV studies to check other aspects of treatment. They might compare the treatment with other treatments available. They might examine how the treatment affects participants’ quality of life. Or they might determine the affordability of the treatment.

Phase IV studies aim to answer a very important question for researchers and pharmaceutical companies: “Is there anything else we need to know about the treatment?”

Key Points of Phase 4 Clinical Trials

• Phase IV studies look at drugs that the FDA has already approved. The drugs are available for doctors to prescribe for patients, but phase IV clinical studies might still be needed to answer important questions.
• These studies may involve thousands of participants.
• Phase IV studies are often the safest type of clinical trial since the treatment has already been studied and has likely been given to many people. Phase IV clinical studies look at safety over time.
• Phase IV studies may also look at other aspects of the treatment, such as quality of life or cost-effectiveness.

Number of Participants

Treatments in phase IV research trials are already on the market and available to physicians and patients. The care provided in the study is similar to the care patients can expect to receive outside the study. Also, because the treatments have received FDA approval, phase IV clinical trials are typically the safest phase to join as a study participant.

Typically, several hundred or thousands of participants take part in phase IV trials. In joining a phase IV clinical trial, participants are helping researchers collect more information about the treatment, which may help patients who will need the treatment in the future.

Uses of Treatment Groups

While extensive, the first 3 phases of clinical research involve a small number of participants compared to the general population. Phase IV clinical trials provide important information about a treatment’s effectiveness by testing more people over a longer time. If the trial reveals harmful side effects, the treatment may be placed under restrictions or taken off the market.

Uses of Placebo

There is little use of blinding or placebo control in Phase IV because efficacy has already been established. These studies are pragmatic and may be considerably more informative in terms of everyday clinical relevance.

Safety and Efficacy Evaluation

In a phase IV clinical trial, any rare or long-term effects of the treatment can be observed in a much larger population of people and over a much longer period.

If the safety surveillance reveals concerns about the drug, it may be withdrawn from the market and no longer made available on prescription.

Length of Study

Since phase IV studies aim to study how a treatment will perform in the long run, it shouldn’t come as a surprise that it takes quite a long time. Typically, they’re conducted for at least two years.

Interested in Enrolling in a Clinical Trial? Call Santos Research Center today!

Enroll in our currently open research studies and join us in helping the future of medicine at Santos Research Center, Corp. now!

We have completed over 400 clinical research trials. We use efficient and reliable systems to plan and manage quality research studies.

For more information about Phase IV clinical trials, you may visit us at www.santosresearch.com.

If you are interested in participating in a paid clinical trial, call us at (813) 249-9100.