Newlab

Clinical Trials

Before being made available to the general public, a new drug must pass rigorous evaluations to show that it is safe and effective for treating a disease. These evaluations are called clinical trials. The results of carefully conducted clinical trials in a number of patients are analyzed to determine if the benefits of taking the drug outweigh the risks. Clinical trials are normally done in four phases to evaluate the risks and benefits of the product.

Phase I
Phase I studies are the first tests of the drug in people. Although these studies are not performed by NewLab, all trials that NewLab executes have successfully completed this initial phase. They look mainly at a drug’s safety and are usually done in a small number of healthy patients which typically takes several months. Phase I patients do not necessarily have the target disorder of the treatment.

Phase II
Phase II studies test the drug in patients who have the disease that the drug is expected to improve. They evaluate both the effectiveness and safety of the drug and include more patients than phase I studies. These trials are usually double-blinded with placebo controls (neither the investigator nor patient know if the patient is receiving active drug or not). This phase can last up to two years. A well designed phase II trial can identify a drug’s likelihood of passing the more expensive phase III trial.

Phase III
Phase III studies are quite similar to phase II studies except they usually involve a large number of patients ranging from hundreds to several thousands. For dermatology there are usually 1500 patients in a phase III clinical trial. Because phase I and II trials have already established the safety of the candidate drug, the risks of phase III trials are minimal. Once a drug passes a phase III trial, the company that developed it can apply for approval to market the drug.

Phase IV
Phase IV studies are also called ‘post-marketing studies’, as they are conducted following the regulatory approval for the sale of new pharmaceutical products. These are usually long term studies that are used to pick up any long term benefits or side effects.

	Clinical Trials Before being made available to the general public, a new drug must pass rigorous evaluations to show that it is safe and effective for treating a disease. These evaluations are called clinical trials. The results of carefully conducted clinical trials in a number of patients are analyzed to determine if the benefits of taking the drug outweigh the risks. Clinical trials are normally done in four phases to evaluate the risks and benefits of the product. Phase I Phase I studies are the first tests of the drug in people. Although these studies are not performed by NewLab, all trials that NewLab executes have successfully completed this initial phase. They look mainly at a drug’s safety and are usually done in a small number of healthy patients which typically takes several months. Phase I patients do not necessarily have the target disorder of the treatment. Phase II Phase II studies test the drug in patients who have the disease that the drug is expected to improve. They evaluate both the effectiveness and safety of the drug and include more patients than phase I studies. These trials are usually double-blinded with placebo controls (neither the investigator nor patient know if the patient is receiving active drug or not). This phase can last up to two years. A well designed phase II trial can identify a drug’s likelihood of passing the more expensive phase III trial. Phase III Phase III studies are quite similar to phase II studies except they usually involve a large number of patients ranging from hundreds to several thousands. For dermatology there are usually 1500 patients in a phase III clinical trial. Because phase I and II trials have already established the safety of the candidate drug, the risks of phase III trials are minimal. Once a drug passes a phase III trial, the company that developed it can apply for approval to market the drug. Phase IV Phase IV studies are also called ‘post-marketing studies’, as they are conducted following the regulatory approval for the sale of new pharmaceutical products. These are usually long term studies that are used to pick up any long term benefits or side effects.