Clinical trials are essential for finding out new and improved ways to treat, prevent, or diagnose different types of illnesses.
There has been plenty of advancements at University Cancer Centers, thanks to these clinical trials.
Clinical trials are useful when you have an illness and have run out of effective treatments. In case you are thinking of applying to a clinical trial or are trying to understand the results from one, you are most likely to come across terms related to clinical research and what that trial is all about.
The category that each trial will fall into depends on the factors and the number of participants involved.
Four different stages in each clinical trial are called phases that build up information from the previous phase.
The Four Phases of Clinical Trials
In the initial Phase 1 trials, a newly launched drug is used on human beings to see the side effects and analyze the early signs of how well the therapy works. This trial enrolls about 20-50 patients.
Phase 2 clinical trials include about 20 to 100 participants, where the focus is to figure out whether the treatment is effective or not. The safety of the patients is in mind at all times. These trials are vital in studying whether this experimental treatment works in treating a specific type of cancer.
Phase 3 clinical trials compare the new experimental drug with the standard treatment approach to see whether the new procedure is better. These trials enroll over a hundred patients.
Phase 4 trials happen after the Food and Administration (FDA) approvals. These trials look to identify problems that did not come to attention before. This trial is also crucial in finding out the long-term benefits of the new drug in addition to any side effects.
Whichever phase you plan to join, here are 12 terms you must know
12 Clinical Trial Terms You Must Know
Adverse Event: Any side effect or an extreme negative change in health experienced after the experimental treatment is known as an adverse event. Adverse events can range from mild to severe. If serious they can cause temporary or permanent disability or may result in hospitalization.
Baseline Characteristics: All the data collected at the beginning of a clinical study for all participants is known as baseline characteristics. These usually include age, gender, race, or any specific measures (for example blood pressure, or diabetes).
Confidentiality: The participant’s identity and all personal medical details related to the clinical trial are kept extremely private. The results will not mention any name without permission and will be presented in terms of overall findings.
Control Group: The control group consists of participants who do not receive the experimental treatment. These participants are assigned to be in the group to compare with the experimental group.
Eligibility Criteria: These are the factors on which the clinical trial participants are chosen. These differ from trial to trial.
Experimental Group: These are the participants who receive the experimental treatment.
Endpoint: An event or an outcome that can be measured objectively is an endpoint. In a clinical study, the endpoints are usually relief of symptoms, improvement in the quality of life, survival, or disappearance of the tumor.
Informed Consent: If a participant provides informed consent, it means that he or she is aware of all the key facts, risks, and benefits of a research study and has agreed to take part in it.
Placebo: A placebo is anything that seems to be a real medical treatment but isn’t. It is most commonly combined with standard treatment. People in one group get the tested drug, while the others receive a fake drug, or placebo, that they think is the real thing.
Treatment Arm: To discover whether a new treatment has done better than the current treatments, patients in clinical trials are divided into different groups called arms to simplify the comparison.
Research biopsy: To help with the initial diagnosis, a tissue sample is removed from the tumor for testing in a biopsy. And for a better understanding of the experimental drug, some clinical trials prefer treatment for additional biopsies.
Performance status: Certain criteria have to be met for one to participate in a clinical trial. These require the patient to be healthy enough for daily activities such as walking, bathing and getting dressed. The score that you get is known as your performance status.
These frequent terms used in clinical trials will help you navigate through the process smoothly.
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