How does the clinical trial process work?

One group receives an existing treatment for a condition and the second group receives a new treatment. Researchers then compare which group performs better. One group receives a new treatment and the second group receives a placebo, an inactive product that looks like the test product. clinical trials progress through four phases to test a treatment, find the right dose and detect side effects.

If, after the first three phases, researchers consider a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects. Clinical trials are conducted in phases. Each phase is designed to answer certain questions, while taking the necessary steps to protect the people involved. Each new treatment is generally tested in three phases of clinical trials before regulatory agencies consider it safe and effective.

The trials are also conducted in accordance with Good Clinical Practice (GCP) guidelines that regulators require to protect patient safety. Clinical trials follow a typical series, from initial, small-scale, phase 1 studies to large-scale, late-stage phase 3 studies. Phase 1 studies are closely monitored and collect information about how a drug interacts with the human body. Researchers adjust dosing schedules based on animal data to find out how much drug the body can tolerate and what its acute side effects are.

As the phase 1 trial continues, researchers answer research questions related to how it works in the body, the side effects associated with increasing the dose, and early information on the effectiveness of drug administration in limiting risks and maximizing potential benefits. This is important for the design of phase 2 studies. Phase 3 studies provide most safety data. In previous studies, less common side effects may not have been detected.

Because these studies are longer and longer lasting, results are more likely to show rare or long-term side effects. 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 used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA). Clinical trials provide the basis for the development and commercialization of new drugs, biologics and medical devices. Sometimes, the safety and effectiveness of the experimental approach or use may not be fully understood at the time of the trial.

Some trials may offer participants direct medical benefits, while others may not. 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. For trials approved by IRBs, IRB has decided that participation risks have been minimized and reasonable relative to anticipated benefits. These requirements will be described in the informed consent document.

A potential participant should also discuss these issues with members of the research team and with their regular healthcare provider. Anyone interested in participating in a clinical trial should know as much as possible about the study and feel comfortable asking the research team questions about the study, related procedures, and any expenses. The following questions may be useful during this discussion:. The answers to some of these questions are provided in the Informed Consent document.

Many of the questions are specific to clinical trials, but some also apply to observational studies. Clinical trials are conducted in steps called phases. In each phase, researchers try to answer a different question. Each phase needs a different group of participants, so one participant only joins one test at a time.

Clinical Trials Help Researchers Discover and Apply Critical Advances in Patient Care. Clinical trials follow rigorous scientific processes that usually take many years to complete. However, during the COVID-19 pandemic, people have been able to see and experience clinical trials that work with rapid progress. And many people wonder: How do clinical trials work? This quarter of 26A, the Mayo Clinic News Network team sat down with Dr.

Naveen Pereira, a cardiologist at Mayo Clinic, and Dr. Andrew Badley, Mayo Clinic Infectious Disease Specialist and Chair of Mayo Clinic's COVID-19 Research Working Group, for answers and ideas on some of the most common questions people have about clinical trials. It starts with understanding how these pathways work. And then a screening process is created to find chemicals or molecules that block that pathway.

Then, there is a phase called medicinal chemistry, in which chemists take the chemical or molecule they found through the selection process and make hundreds or thousands of variations to design the most desired properties, have fewer side effects or be more effective, of those thousands of compounds, it is often reduced to one or two with the desired characteristics, and then toxicity tests are performed to determine if they do something unwanted. You do hundreds of experiments to show that you pass that level of scrutiny. It then submits it to the FDA (Food and Drug Administration) for review and approval for clinical trials. And the FDA, with great caution, very often comes back and says, “Yes, this looks good, but please do more experiments”.

Therefore, the process for obtaining an FDA review is robust, and the process to go through an FDA review and approval is even more robust. We tested some of these drugs at hundreds of sites at the same time, which led to a faster accumulation of patients and, therefore, the ability to draw conclusions about efficacy in a more rapid manner. Before a clinical trial begins, researchers review previous information about the drug to develop research questions and objectives. An IRB is an independent committee made up of doctors, statisticians and community members who ensure that clinical trials are ethical and that the rights of participants are protected.

The goal of clinical trials is to determine whether these treatment, prevention, and behavioral approaches are safe and effective. Phase 4 trials are conducted once the drug or device has been approved by the FDA during post-marketing safety monitoring. Most, but not all, clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) to ensure that risks are reduced and offset by potential benefits. After a clinical trial or study is complete, researchers will collect and analyze the data to see what next steps are needed as a result of the findings.

Therefore, we gathered all this valuable information in early-stage clinical trials and tried to determine what we think is the most effective treatment. The dignity, rights, safety and well-being of individuals involved in clinical research must be promoted and protected at all times and in any part of the world where clinical trials are conducted. Informed consent is the process of knowing the key facts of a clinical trial before deciding whether to participate. As long as clinical trials are carefully designed, reflect what developers know about a product, protect participants, and comply with federal standards, FDA allows ample freedom in clinical trial design.

Therefore, a participant may change his/her decision; any participant has the right to withdraw at any time during the trial. Since clinical research participants voluntarily provide information that cannot be obtained in any other way, they clearly deserve the gratitude and respect of the global community. The developer is responsible for informing the review team about the new protocols as well as the serious side effects observed during the trial. Carefully conducted clinical trials are the fastest and safest way to find treatments that help people.

After researchers test new therapies or research procedures in the laboratory and in animal studies, those with the most promising possibilities move on to human clinical trials. . .

Bernice Gerchak
Bernice Gerchak

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