What are Phase 3 clinical trials?
Phase 3 clinical trials are large-scale studies that gather more information about safety and effectiveness by studying different populations and different dosages, using the drug in combination with other drugs, or studying the effects over a longer period of time. Phase 3 trials typically involve several hundred patients.
How do you participate in a Phase 3 trial?
If you think a Phase 3 clinical trial may be right for you, there are several ways to get involved. You can speak with your physician and see what they recommend; they may be able to suggest some trials that fit your medical needs. If you’re interested in researching trials yourself, sites like ClinicalTrials.gov offer directories of trials that meet specific medical criteria. Finally, asking friends and family members who have participated in clinical trials can also lead to great resources.
What happens during a Phase 3 trial?
Typically, Phase 3 trials take a long time to complete because they involve hundreds or thousands of participants. These trials typically last from one to four years.
In a Phase 3 trial, you might be randomly selected to receive the experimental treatment or a placebo (treatment with no active drug), though some trials compare the experimental treatment with a standard treatment that is already approved and in use. For example, some researchers may want to test whether an experimental drug is better than an already FDA-approved drug for treating a certain disease or condition.
In Phase 3 clinical trials, participants are closely monitored by the research team throughout their participation. This can include regular visits with study staff and sometimes staying overnight in the hospital so medical staff can monitor your progress and collect data such as blood samples or ECG (electrocardiogram). Most of these clinical research studies provide free medical care related to the trial and free investigational products (for example, medications being studied). You may also be compensated for your travel expenses.
What risks are involved in participating?
As with any type of clinical trial, there are potential risks that you should be aware of. Phase 3 clinical trials will test the safety and effectiveness of a new drug or medical device, but since they involve human participants, there is always a risk of unexpected adverse effects. Depending on the type of study being conducted (e.g., randomized double-blind), it’s also possible that you may receive either a placebo or an already existing treatment rather than the experimental drug or device being tested.
How likely are these adverse effects? Well, it depends upon the drug/device being tested and what types of side effects have been seen in participants who have taken it in previous phases. Side effects that can occur from taking these drugs include headache, flu-like symptoms, nausea, vomiting and diarrhea. Depending on what’s being tested, though, these side effects may be milder than if you were to get them from taking too much cold medicine or had food poisoning—or they may be more severe than other risks involved (more about those later).
The most important thing is to inform yourself before enrolling as much as you can about the risks associated with taking an experimental treatment so that you can make an informed decision whether this is something that’s right for your situation and lifestyle!
Who pays for a Phase 3 trial?
A trial sponsor pays for the costs of a clinical trial—usually, this is the pharmaceutical company, but it could also be a university, hospital, or government agency. The budget for Phase 3 trials is determined during Phase 1 and Phase 2 based on the estimated number of patients and study sites needed to test a product’s safety and effectiveness. This budget will cover not only the costs of the trial (such as administering treatments, monitoring adverse events and lab tests) but also the cost of drugs or devices being tested.
What if there’s an emergency during a trial?
You may be wondering, “What if there’s an emergency during a trial?”
Well, the emergency procedures are defined in the protocol and the study sponsor has a plan to respond to emergencies. The study team will work with your insurance company and the medical staff at the study site to ensure that you get the best care possible.
What if I change my mind after joining a trial?
You have the right to leave a trial at any time. However, you should talk to your doctor before you decide to leave a trial. If you stop taking a drug that’s being tested during the trial, your symptoms could return or worsen.
Also, if you leave a Phase 3 clinical trial early, it may be difficult for researchers to know whether the drug helped or hurt you; this might keep them from completing their study. In addition, in some trials, participants taking a placebo receive treatment after the study ends. If you leave early and are on the placebo, it’s possible that you could miss out on this benefit.
Finally, if you leave a Phase 3 clinical trial early and need medical care for an illness related to participating in the study—whether it was caused by treatment or occurred without treatment—you may have to pay for the cost of that care yourself. Although these costs are rare, they can be significant if they do occur.
If you finish all required visits and procedures while enrolled in a Phase 3 clinical trial but stop taking your assigned therapy before completing all required follow-up visits and procedures specified in the protocol (schedule of tests), remember that even then:
Who’s involved in a Phase 3 trial?
A Phase 3 clinical trial is a complex operation. In addition to the people who participate in it, there’s an entire team of highly-trained professionals working behind the scenes to ensure that it runs smoothly and safely. They work together with the trial sponsor (a pharmaceutical company, university, research institution, or other organization) to carry out all the necessary steps of a Phase 3 trial.
We’ve already discussed how participants are recruited into a clinical trial with help from doctors and other healthcare professionals. These individuals may also be considered investigators because they’re involved in every aspect of patient care during the trial—everything from prescribing treatment to diagnosing conditions and collecting biological samples for testing. Other investigators include pharmacists, nurses, data analysts and physicians with special expertise in study design or statistics.
It can be difficult for patients to find out about clinical trials at their stage in development, so another group called recruiters contacts potential participants through media ads or posters put up around town. These typically describe what type of person would fit best into each different kind of study (e.g., “Women age 18-40 needed for diabetes research”) so that only appropriate volunteers sign up for specific trials.
Phase 3 Trials are critical to finding new and effective treatments for patients.
Phase 3 trials are important for several reasons. They allow drug companies to provide the strongest evidence of drugs’ safety and efficacy, which is necessary in order to get FDA approval and start selling the drug on the market. Additionally, they play a critical role in finding new treatments and therapies for patients, who may have previously been unable to find effective treatment. Phase 3 trials also provide us with a better understanding of diseases by helping us learn more about how they progress, which helps us treat them more effectively.