Clinical trials are studies that are used to test novel medications, existing drugs, technologies, or other therapies. Many clinical trials investigate new methods for detecting, diagnosing, and measuring the severity of disease. Some researchers are even looking into ways to prevent diseases from occurring. Human volunteers are still used to test these methods, and the same regulations apply. Clinical trials are used to test medical interventions such as medications, cells, and other biological products, surgical operations, radiological treatments, equipment, behavioural therapies, and preventative care. Clinical trials must be authorized before they can begin, as they must be carefully prepared, evaluated, and performed. Clinical trials are open to people of all ages, including children.
What are the four phases of clinical trials in Houston?
Clinical trials go through four stages to evaluate a medication, determine the proper dosage, and examine for negative effects. If researchers find a medicine or other intervention to be safe and effective after the first three phases, the FDA approves it for clinical use and continues to evaluate its effects.
Phase I
The first stage in putting a new treatment to the test in people. A phase I clinical study evaluates a novel treatment’s safety, adverse effects, appropriate dose, and timing. It could also assess the optimal manner to provide a new medication (for example, by mouth, vein infusion, or injection) as well as how the medicine affects the body.
To determine the greatest dose that does not cause significant side effects, the dose is normally increased a little at a time. Only a small number of individuals who have failed to respond to other treatments are usually included in phase I clinical trials. They occasionally include healthy volunteers. Also known as a phase one clinical experiment. Investigators consider the best manner to administer the medicine, such as orally, intravenously, or topically, in addition to its safety and optimal dosage.
According to the FDA, around 70% of drugs are progressed to phase II.
Some key factors of phase I are-
- The first few participants in the research are given a very modest dose of the medication and are closely monitored.
- Phase I studies also look at how the medicine affects the body and how the body reacts to it.
- The researchers maintain a careful check on the participants and keep an eye out for any serious adverse effects.
- While some people may benefit from participating in one, the primary goal of a phase I trial is not to improve disease outcomes. Placebos (inactive therapies) are not utilised in phase I trials.
Phase II
A phase II clinical study is conducted if a new medication is found to be safe in phase I clinical trials and to see if it works in specific forms of cancer. The advantage that doctors seek is determined by the treatment’s purpose. It could indicate that the cancer is shrinking or disappearing. It could also suggest that the cancer will not grow any larger for a long time, or that it will take longer for the disease to return. According to some studies, the benefit could be a higher quality of life. Many clinical studies examine whether people who get a novel treatment survive longer than people who do not receive the treatment.
Some key points of phase II trial-
- In a phase II study, a group of 25 to 100 patients with the same form of cancer receives the new treatment. They’re given the dose and manner that phase I trials revealed to be the safest and most effective.
- Everyone receives the same dose in phase II clinical trials. However, some phase II studies allocate patients to different treatment groups at random.
- In phase II trials, no placebos are employed.
- Major cancer centres, community hospitals, and even doctors’ offices may conduct Phase II research.
According to the FDA, around 33% of drugs enter phase III testing.
Phase III
In a Phase III clinical trial, up to 3,000 people with the illness that the new medication is supposed to cure are routinely enrolled. This stage of the trial can last several years.
The goal of phase III is to compare the new medication’s effectiveness to that of other drugs for the same illness. To proceed with the trial, researchers must show that the medicine is at least as safe and effective as currently available treatments. Because doctors are unsure which treatment is better, research participants are often assigned to either the standard or novel treatment at random (called randomised). When feasible, neither the doctor nor the patient is aware of which treatment is being administered.
The FDA will normally authorize a pharmaceutical if scientists show that it is at least as safe and effective as other medications already on the market. Approximately 25 to 30 percent of drugs are moved to phase IV.
Some key factors of phase III –
- The majority of phase III clinical trials involve a high number of patients, usually several hundred.
- Phase III studies are often lengthier than phase I and II research.
- In some phase III studies, placebos may be utilised, although they are never used alone if a better treatment is available.
- Local community hospitals and doctor’s offices are more likely to provide Phase III clinical studies.
- These studies are frequently conducted simultaneously in multiple locations including Houston.
Conclusion
Clinical trials and their many stages are critical components of clinical research. They enable the correct assessment of the safety and effectiveness of new drugs or therapies before they are licenced for use in the general public. Investigators use human cell cultures or animal models to undertake preclinical research before starting a clinical trial. While clinical trials are vital, the decision to participate in one is a personal one that is based on your specific circumstances. When faced with a clinical study, everyone must measure the advantages against the dangers and decide what is best for them.