The Four Phases of Clinical Trials

The Four Phases of Clinical Trials

Clinical trials test new medical treatments, such as drugs or devices. They are conducted in four phases. Before the FDA can approve a drug, it must pass through three clinical trial phases. Doctors compare the experimental treatment to the best existing therapy during these phases. Some clinical trials focus on prevention, screening or diagnosis. Others explore treatment approaches for already-existing diseases or conditions.

Phase I Trials

A critical stage in the creation of new therapies is the conduct of clinical trials. They test how well a treatment works, whether it’s a drug or a new way of doing surgery, for example. Often, they’re the final step in a years-long process that began with laboratory work and animal studies. Along with receiving the normal treatments we provide, some of our patients opt to participate in a clinical trial. They want to be part of advancing medical knowledge and receiving cutting-edge care, which they understand can lead to better outcomes.

The information collected from the patient’s experience in a trial is recorded and analyzed to ensure participants’ safety and the treatment’s efficacy. Each study has guidelines for who can or cannot join, called eligibility criteria. These criteria are designed to remove the chance of random chance-altering results. Eligibility criteria can include age, diagnosis and medical history.

Phase II Trials

In this clinical trial stage, participants with the condition being treated are randomly assigned to either the experimental drug or one of the standard treatments used in treating the disease. The experimental drugs are monitored for side effects and compared to the standard treatment to assess effectiveness and safety. During the research phase, you will be under close monitoring and medical attention from our physicians, nurses, and researchers. They can detect any side effects from the trial and alert you immediately, giving you a much higher level of medical care than you would receive otherwise. As the results of the clinical trials are gathered and evaluated, doctors use them to develop new treatments. It allows us to offer cutting-edge dermatology services that may not be available elsewhere. Doctors are always searching for ways to improve the lives of our patients and make their procedures more effective, safer, and quicker.

Participants of all ages and stages are eligible to participate in clinical trials as long as they meet the criteria for eligibility. Empirical interview results indicated that many nurses and physicians believe that participation in a clinical trial gives patients access to an experimental therapy superior to standard care. However, the interviews revealed no evidence to support claims that experimental treatment is better than usual care. Therefore, recruiters must refrain from making claims of this nature, as they are an inappropriate deviation from well-established requirements for providing information before consent.

Phase III Trials

Clinical trials are the only way to know if a promising new treatment will work. They are carefully designed and monitored, and ethical committees and regulatory authorities oversee them to ensure they are safe for participants. Hundreds of individuals in various clinical settings and hospitals receive the investigational medicine during the final trial phase. It helps doctors collect more information about the treatment over time and in a large group to watch for long-term side effects. The clinical trial results are analyzed to determine which treatments are most effective. Some of these trials are done with patients matched by factors like age, gender, stage or other criteria. It is called randomization and eliminates the possibility of bias. Some trials are double-masked, meaning neither doctors nor patients know which arm of the test each patient is in. Phase III clinical trials involve hundreds or thousands of people with the same disease. These larger trials compare the experimental drugs with standard treatment approaches to see if they are safer and more effective. They also look at longer-term side effects of the drug or treatment. If a drug proves safe and effective in this phase, doctors can recommend it to their patients.

People from diverse backgrounds must join clinical trials so that the results accurately represent the broader population of patients that will use the medical products. However, structural barriers prevent adequate representation of underrepresented populations in clinical trials. Insufficiently representative clinical trials can lead to care protocols that may not be appropriate for underrepresented patients, even if the results appear promising.

Phase IV Trials

Clinical trials help market new medical treatments, drugs, devices, novel surgical techniques, or genes faster. The research volunteers who participate in them are vital to the advancement of medicine, and they benefit from better health outcomes down the road. These early-stage studies are typically conducted with a small group of participants (20 to 50) and focus on determining the drug’s safe dosage, side effects, and signs that it works. These trials can also test different drug combinations or dosing schedules. During this phase, doctors can measure the drug’s effectiveness or treatment by comparing it to the standard therapy approach. These are often randomized studies (where similar groups of patients are assigned to receive either the experimental drug or the currently used treatment) and double-blinded (meaning neither the patient nor their doctor knows which medicine is being administered).

In addition to the time it takes for pharmaceutical companies, researchers, and physicians to recruit and enroll participants in their trials, several other factors can bog down the clinical trial process. For example, many patient-related expenses — such as travel, meals, and lodging — can add up. It is because trials are frequently conducted at multiple locations. And a lack of efficient methods for monitoring clinical trial progress can increase the time it takes to get a new drug to market.

Recommended Articles