what does a phase III trial mean?

Question

i am doing research and i keep coming across the terms phase I, II & III trials, does anyone know what this means?

Answer 1

These are steps in the clinical trial process for a new drug/medicine.

Phase I clinical trials are principally designed to examine the safety of the drug. Further trials and development can not take place unless Phase I trials show the drug to be reasonably safe when administered to humans.

Participants in this trial are closely scrutinized for the smallest indication of harm caused by the medicine. Because safety is still a question, these trials are necessarily small in scope. But they also give researchers an opportunity to begin to understand how the drug will work in humans.

Phase II clinical trials are designed to confirm safety, determine efficacy in humans over the short term, and help set up parameters (e.g. dosage) of the longer-term Phase III trials. Phase II trials are typically placebo-controlled and double-blinded: neither the patient nor the medical personnel know whether the patient is receiving the drug or a dummy placebo. These trials are larger in scope than Phase I and tend to take more time.

Phase III trials are designed to prove the efficacy and safety of a drug over the long term. They are usually double-blinded and placebo-controlled and can involve hundreds or even thousands of patients over many months or even years. Though the numbers of patients involved can be great, the risks are relatively minimal
because of the earlier testing to establish safety. The large scope of these trials gives researchers opportunity to observe and prove benefits and overall safety of the medicine as well as to identify rare side effects of treatment, if any.
Phase III trials are extraordinarily expensive in terms of time, money and effort.

Awaiting Regulatory Approval
Once all phases of clinical testing have been completed, the biotech/drug company applies to the Food and Drug Administration (FDA) for regulatory clearance to market the medicine in the United States (other countries have analogous regulatory agencies). If the FDA agrees that the data proves the safety and efficacy of the drug, clearance may come in several months or years, with those medicines with the most urgent medical need typically cleared more quickly. Drug companies work closely with regulatory agencies at all stages of clinical development to help ensure it can provide needed data to obtain approval as quickly as possible.

Answer 2

Phase I trials are called "first time in man". This means that a drug or medical device is being tested for the very first time. These are usually small (10-15 patients) and are often done in "normal, healthy" people. They are done in very controlled environments, like a hospital.

Phase II is when a drug begins to be tested in humans for a particular disease state. These are a little bigger, and usually have 100-300 patients.

Phase III is also called "pivotal" and is the final stage of testing before a drug is submitted to the FDA for approval. These are large trials designed to show efficacy of a drug and safety.

Answer 3

I can give you a pretty good answer. When a company is preparing to put a new drug on the market, they must test it on actual people. This happens way down the line, right before it is approved. This testing happens in phases, phase 3 is the last phase before the drug is approved. I don't know if this terminology applies to the testing of other things other than drugs, but it probably does.

Answer 4

it means it had better work this time

it means I don't know, depends on the industry. If you're in the field of clinical trials, there is almost certainly a sequence of trials you'd need to go through that is standard for everyone. Could that be it?