What is a clinical trial and how does it work?

A clinical trial is a research study conducted in humans aimed at answering specific questions about new therapies, vaccines, or diagnostic procedures, or new ways of using known treatments.

clinical trials

are used to determine if new drugs, diagnoses or treatments are safe and effective. In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the researchers. These interventions can be medical products, such as medications or devices; procedures; or changes in participants' behavior, such as diet.

Clinical trials may compare a new medical approach to a standard one that is already available, with a placebo that contains no active ingredients, or with no intervention. Some clinical trials compare interventions that are already available with each other. When studying a new product or approach, it is generally not known whether it will be useful, harmful or will not be different from available alternatives (including non-intervention). Researchers try to determine the safety and effectiveness of the intervention by measuring certain outcomes in participants.

For example, researchers may give a medication or treatment to participants who have high blood pressure to see if their blood pressure drops. Clinical trials are research studies that aim to determine whether a medical strategy, treatment, or device is safe for human use or consumption. Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to participate in clinical trials to test medical interventions, including drugs, cells and other biologics, surgical procedures, radiological procedures, devices, behavioral treatments, and preventive care.

Clinical trials are carefully designed, reviewed and completed, and must be approved before they can begin. People of all ages can participate in clinical trials, including children. Clinical trials typically include participants from more than one medical or research institution and often from more than one country. As each country has its own requirements for clinical trial research, individual trials may be included in more than one registry and therefore appear in more than one registry database.

However, data from several clinical trial registries vary. In a phase 3 clinical trial, you'll be part of a larger group of people with the medical condition being studied. By participating in a phase 2 clinical trial, you are helping researchers better understand how well the study medication may work for the condition being studied and the side effects that may occur. It is essential that clinical trials include people with a variety of lived experiences and living conditions, as well as characteristics such as race and ethnicity, age, sex and sexual orientation, for all communities to benefit from scientific advances.

Most trials involve some risk of harm or injury to the participant, although it may not be greater than the risks related to routine medical care or disease progression. The way to find out if a new drug is safe or effective is to test it in patients in clinical trials. Clinical research requires complex and rigorous testing in collaboration with communities affected by the disease. When clinical trials include diverse participants, the results of the study may have much broader applicability.

Clinical trials in humans are carried out in the final stages of a long, systematic and thorough research process. The purpose of a clinical trial is to find a new and improved way to treat, prevent or diagnose different types of diseases. The trial sponsor, often the pharmaceutical company that develops the therapy or drug, designs the protocol for the clinical trial. Clinical trials also have a research team that may include doctors, nurses, social workers and other health professionals.

Participants are expected to carefully read the consent document, decide if they want to register and sign it before they can be included in the trial. Several federal agencies, including the Office for the Protection of Research on Human Subjects and the FDA, have the authority to determine whether sponsors of certain clinical trials adequately protect research participants. The following is information that can help you decide if participating in a clinical trial is right for you. .

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