Clinical trials take new drugs and devices into human testing. Thousands of people around the world are enrolled in clinical trials at any given time. These clinical trials have paved the way for many of the new advances that have changed the course of medical history for the better. Clinical trials follow very stringent procedures and rules, known as protocols, to help the participants from any possible health hazards, and to collect valid and accurate data from the trial for submission to regulatory agencies. To participate in a clinical trial, each patient must sign a document that says they understand there are possible risks, but that the benefits might be worth it; so they agree to join.
In order to record the effects of medicines or devices being tested, clinical trials are conducted in phases. These are
step by step levels in which a clinical trial is being accomplished. It is generally divided into 5 different phases. Here are a few brief details on each of the phases and associated activities.
Phase 0 is the name of the first stage of the clinical trials in humans. During the first test in humans, the treatment or medication is applied to the patient in micro doses. A small amount of the drug is administered to a patient group- called participants. Patients are evaluated and monitored so closely to determine if the expected effects are visible over their body or disease or not. The dose is usually minute because the therapeutic goal is being tested to determine if the effects are visible or not. It is intended to test the tolerance. This allows researchers to test the feasibility of a large number of drugs and make decisions accordingly.
Phase 1 trials are those where a normal therapeutic dose is injected into humans. Different types of studies in this phase of the studies, including ascending single dose of the multiple dose study bottom-up study of the effects of food, are made and recorded here. Once approved for an increase in dose, the participant is given multiple doses and then recorded for reactions. This helps to determine the effectiveness as well as absorption of drugs in the human body.
Trials of phase II begin only after the drug safety has been verified in the previous phase. The largest groups of up to 300 patients are used at this stage and are intended to assess the effectiveness of the treatment or drug. Researchers continue to monitor side effects, tolerability and safety of the band of the largest groups on the other.
The phase IIA deals with the evaluation of effective dose. In phase II B, studies determine the effectiveness of the medication and its effectiveness on the participant.
Trials of phase III usually begin with the patient group generally numbered in thousands. They are designed in such a way that they provide data on how it works on established broader population. In order to provide information on the side effects of the drugs and grants, current therapies are measured against performance.
Trials of phase IV follows phase III and the final process when the drugs reach the market. These studies allow monitoring long-term side effects that are not seen and the study medication in some previous population groups not included in the original studies. The bad side effects in phase IV often can lead to drugs being withdrawn from the market. This terminates the clinical trial cycle here.
Which One is Right for you?
Quite a typical question to be asked! Most of the people assume that they can enter any phase of clinical trial without any problem however, as we can see, it is a sequential flow of experiments and events, you need to follow the complete pattern of trials to make sure that no harm is done to your body as well as the tests producing positive results. In case you already have been a part of a clinical trial and are now opting for a new one in between, you need to consult the researchers and medical scientists. They will know the details and history of tests that have already been performed on you and then suggest which phase you should join. Usually, you will be asked to join the first phase of the clinical trial as the process and procedure being followed in each of the phases is different from others. Furthermore, it also depends on the stage of illness you are currently at. If you are suffering from severe disease then you will be might join Phase II or others as per the condition and capabilities of your body.