Phase III clinical trials are the final stage of research and development before regulatory authorities can approve a drug. These trials are larger, more cost-intensive, and more complex than previous phases of drug development. Phase III clinical trials typically involve hundreds to thousands of patients at multiple sites globally across North America, South America, Europe, Asia, or Australia/New Zealand. Researchers test whether a new drug, treatment, or medical device is safe and effective under real-world conditions versus standard-of-care treatment options or placebo in patients with specific types of cancer or other diseases.
What is the purpose of a Phase III clinical trial?
A Phase III clinical trial aims to validate the results of a Phase II clinical trial. The drug, treatment, or medical device researched must be tested on a larger sample size of study participants and in more diverse locations to ensure that different types of patients can effectively and safely use it.
Phase III clinical trials collect information regarding short and long-term side effects. To have a drug approved, the FDA requires that it pass through three phases: Phase I (safety testing), Phase II (efficacy testing), and Phase III (testing on broader demographics and confirming efficacy).
What is involved in a Phase III clinical trial?
As mentioned above, Phase III trials confirm the efficacy and safety of a drug, treatment, or medical device in large groups of patients. Patient recruitment will be vital to the trial’s success. Hiring a CRO to help with patient recruitment can be a good investment as the CRO will have marketing tactics to recruit the right people for the right trial.
Phase III compares the standard treatment to the new treatment for the tested indication. Since researchers do not know which treatment is better, the trial will be randomized. Study participants will be chosen randomly to receive either the standard or the new treatment and sometimes a placebo. Many Phase III trials will be double-blinded, meaning neither the doctor nor the patient knows which of the treatments the patient will receive.
Phase III is crucial to a treatment coming to market, as this phase represents the final step before marketing approval by regulatory bodies such as the United States Food and Drug Administration (U.S. FDA) or European Medicines Agency (EMA).
How long does a Phase III clinical trial last?
Phase III clinical trials can last for years, as it is critical to have accurate data. Researchers must be meticulous if they want a shot at receiving approval. Phase III trials can be one of the most time-consuming phases. The longer the trial lasts, the more money it costs, making Phase III one of the most expensive in the clinical trial process.
What are the next steps after a Phase III clinical trial?
After a Phase III clinical trial, if successful, the drug will be approved for use. Once a new treatment has proven more effective than the current standard treatment, sponsors can submit a new drug application (NDA) for the FDA to review. If approved, the new treatment may become the new standard of care.
If not approved, the FDA may require more evidence to show that the new treatment’s benefits outweigh the risks. The FDA may request that the treatment be modified or retested in a later phase. It’s important to note that if results are inconclusive, a Phase IV clinical trial may be needed.
Benefits of hiring a CRO for Phase III clinical trials
The benefits of hiring a Contract Research Organization (CRO) for Phase III clinical trials are numerous. First and foremost, it can save you time and money. Many CROs offer reduced fees for early-stage companies or organizations that want to test the market before investing heavily in products and services.
Additionally, working with a CRO gives you access to specialized expertise that would otherwise be unavailable to you – particularly regarding regulatory compliance. Since CROs are experts in their field, they know how best to conduct, manage, and market your product once approved by a regulatory agency.
Ready to start your Phase III trial?
If you’re planning a Phase III clinical trial and want a tech-enabled CRO backed by an expert team of clinical operation leaders, contact Vial today. We can help you make the right decisions for your drug, treatment, or medical device and provide the clinical trial services you need for a faster, more efficient, and cost-effective trial.