The FDA usually requires a phase III clinical trial before approving a new medication. Due to the larger number of participants and longer duration or phase III, rare and long-term side effects are more likely to show up during this phase.

Although FDA had authority under the 1938 Act to establish rules governing the use of investigational drugs, FDA did not employ this authority to regulate clinical trials and clinical trial methodology until 1961.

Getting The Treatment FDA Approved When phase 3 clinical trials (or sometimes phase 2 trials) show a new drug is more effective and safer than the current standard treatment, a New Drug Application (NDA) is submitted to the Food and Drug Administration (FDA) for approval.

Summary

Clinical trials are an integral part of new product discovery and development, and are generally required by the Food and Drug Administration (FDA) before a new product can be brought to the market.

Types of Clinical Trials. There are several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials, and natural history studies.

Racial and ethnic minorities Racial and ethnic minority groups are often underrepresented in clinical trials. For example, African American patients represent 13.3% of the US population but only make up 5% of patients enrolled in clinical trials supporting FDA approval of new drugs9.

Types of clinical trials

• Pilot studies and feasibility studies.
• Prevention trials.
• Screening trials.
• Treatment trials.
• Multi-arm multi-stage (MAMS) trials.
• Cohort studies.
• Case control studies.
• Cross sectional studies.

Treatments that have been shown to work in phase II clinical trials must succeed in one more phase before they’re approved for general use. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment.

A type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market. These trials look for side effects that were not seen in earlier trials and may also study how well a new treatment works over a long period of time.

Information For

• Step 1: Discovery and Development.
• Step 2: Preclinical Research.
• Step 3: Clinical Research.
• Step 4: FDA Drug Review.
• Step 5: FDA Post-Market Drug Safety Monitoring.

A phase II clinical trial tells doctors more about how safe the treatment is and how well it works. Doctors also test whether a new treatment works for a specific cancer. They might measure the tumor, take blood samples, or check how well you can do certain activities.

Phase 2 trials are usually larger than phase 1. There may be up to 100 or so people taking part. Sometimes in a phase 2 trial, a new treatment is compared with another treatment already in use, or with a dummy drug (placebo). Some phase 2 trials are randomised.

The length of study for phase 3 clinical trials is usually 1 to 4 years. This phase involves 300 to 3,000 patients, with tests designed to determine the drug’s longer-term effects.

Phase III takes on the average 3 years. New Drug Application (NDA): Following the Phase III Clinical Trials, the drug manufacturer analyzes all the data from the studies and files an NDA with the FDA (provided the data appear to demonstrate the safety and effectiveness of the drug).