When a pharmaceutical, biotech, or medical device company wants to develop a new drug or medical device, the drug manufacturer will need to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA). An IND application is the means by which sponsors/investigators obtain authorization from the FDA to start human clinical trials. Clinical trials on human participants must undergo multiple phases before being approved by the FDA.
A Phase I clinical trial is the first time that a new drug, treatment, or medical device is tested in human study participants. If the Phase I results are positive, a trial will typically move from Phase I into Phase II. Phase II clinical trials are the second stage in the development of a new drug, treatment, or medical device and usually involve testing in a larger group (usually 100-300 people). Phase III clinical trials are the final stage of research and development before regulatory authorities decide whether or not to approve for the market. These trials are larger, more cost-intensive, and more complex than previous phases of drug development. A Phase III clinical trial aims to validate the results of a Phase II clinical trial. What happens after Phase III? If a treatment is approved by the FDA it will go to market. However, the clinical trial phases don’t end there. Many clinical trials will move into Phase IV. What is Phase IV? Find out below!
What is a Phase IV clinical trial?
A Phase IV clinical trial is a study that examines the long-term effects of a drug or treatment after it has been approved by the (FDA). These studies are typically conducted by the sponsor that created the drug or treatment, which may be an individual company or consortium of companies that worked together to develop it and bring it to the market.
Similarly, these trials expand upon initial safety data, like how the product interacts with other medications and the long-term side effects. Phase IV clinical trials are also sometimes called Post-Marketing Surveillance (PMS) studies and contain a large patient population.
In some cases, there may not be enough time for sponsors to conduct Phase IV studies before approval is granted for their medication or device through the FDA’s New Drug Application (NDA) or Investigational Device Exemption (IDE) process. Phase IV trials can be planned during the Phase III process—before NDA submission—and conducted after approval has been granted.
What is the purpose of a Phase IV trial?
Phase IV studies are conducted by pharmaceutical companies to learn more about how their product is being used, or they may be continuing to gather additional information about the potential side effects of the drug.
Phase IV trials can help doctors determine if a drug should be removed from the market if it poses too much risk to patients. For example, if there were serious side effects with one particular medication and this information was not discovered during pre-marketing (phase I-III) trials. Similarly, Phase IV trials can reveal side effects for patients with certain comorbidities or in combination with certain medications that may require advertised warnings.
How much do Phase IV clinical trials cost?
Clinical trial costs depend on the type of study/phase being conducted. Phase IV clinical trials can cost anywhere from $50,000 to $150 million. These trials are typically more expensive than Phase III trials because they’re being conducted on a drug that has already been approved by the FDA and require significantly higher enrollment rates.
How long do Phase IV clinical trials last?
The length of a Phase IV clinical trial depends on the nature of the drug or treatment being tested. For example, if you’re working on an Alzheimer’s medication and have been conducting Phase III trials for several years, it may take a few more years for a subsequent Phase IV trial to come to its conclusion.
However, all trial durations are dependent on primary and key secondary endpoints, as described in their study design. It is more common that Phase IV trials last from only a few months to several years after the drug has been approved by the FDA. In many cases, these projects are funded by either government agencies or pharmaceutical companies, and relevant data must be reported regularly.
How can Phase IV clinical trials help your business?
Phase IV clinical trials can also assist biotech and pharmaceutical companies to improve their products, services, and technologies by helping them meet regulatory requirements and provide peace of mind to patients. For example, Phase IV trials can provide sponsors with data on whether or not the investigative product is statistically effective at treating certain conditions for which it was designed.
Receiving this type of information from Phase IV clinical trials before FDA approval may allow pharmaceutical companies additional time for making necessary changes prior to submitting applications for marketing authorization.
What happens after a Phase IV trial is complete?
A Phase IV trial is typically considered complete when enrollment is reached, and each patient undergoes their last visit. Once a Phase IV trial is complete, its results are typically published in a peer-reviewed journal. The results will also be submitted to the FDA, which will review them and decide whether the drug should be approved for use by consumers or if any additional safety messages need to be announced.
Researchers, site investigators, sponsors, and CROs involved in a Phase IV clinical trial should receive information about the results of the trial as well as the time frame that the data will be shared with the community.
What are the benefits of using a CRO for a Phase IV trial?
Before beginning a clinical trial, one of the first things sponsors will typically do is consider utilizing a Clinical Research Organization (CRO) to manage the details of the study. Employing a CRO can save time and money as well as provide access to the latest technology.
The following are a few benefits of sponsors using a CRO for their Phase IV clinical trial:
- A CRO can provide access to the latest technology needed for conducting Phase IV studies. This includes the availability of tools like electronic data capture (EDC), Internet-based applications, and more. These tools can help ensure that all information is collected efficiently, accurately, and is easily accessible by those who need it most—like researchers!
- CROs have experience managing Phase IV trials. This means that they know what kinds of protocols work best when conducting Post-Marketing Surveillance studies; which types of people should participate in these studies; where the study sites should be located; etc. The CRO’s main purpose is to ensure everything goes smoothly during the Phase IV trial.
- Another advantage of working with a CRO is the partnership they have with sites, investigators, and vendors. CROs are much more knowledgeable as to which sites can enroll patients for a specific indication. Similarly, an experienced CRO will have a large network of prominent investigators and scientific advisory board members. For the services that the CRO must outsource, they will likely have several vendors with which they’ve had success with in the past.
- The staff employed by a CRO can also be a great benefit during a Phase IV trial. The CRO will vet staff members such as Clinical Research Associates (CRAs), legal representatives, medical monitors, Clinical Trial Managers (CTMs), regulatory coordinators, medical writers, budget advisors, and sometimes even Clinical Research Coordinators (CRCs). These staff members are skilled at managing the complex nature of Phase IV trials and can be invaluable during the start-up and close-out processes in particular.
Ready to Start Your Phase IV Clinical Trial?
Although Phase IV clinical trials can be lengthy and expensive, they are necessary to satisfy regulatory requirements and conclude any unanswered queries that arose during earlier phase studies. In order to manage the complexities and nuances that arise in Phase IV trials, sponsors frequently elicit the assistance of an experienced CRO. CROs like Vial, IQVIA, and PPD can be advantageous through their network of sites, the availability of new technology, and their expert staff.
Vial is a next-generation Contract Research Organization (CRO) powered by technology. Our vision is to empower scientists to cure all human disease. We deliver on this vision by providing faster, more efficient trials at an affordable rate.
If you’re planning a Phase IV clinical trial and want a tech-enabled CRO backed by an expert team of clinical operation leaders, contact Vial today. Vial 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. Contact us today to discuss your trial needs and request a free quote.
