Clinical Study Phases
Glioblastoma multiforme can be considered a rare disease for which no cure exists yet. Traditional therapies include, whenever possible, neuro-surgical intervention, radiotherapy, chemotherapy. To increase the life expectancy we often talk about experimental therapies and trials. This article aims to explain what are the phases and the duration of a clinical study.
Let us say immediately that there are five stages in a clinical study. Only after passing one after the other, all these steps the drug or treatment enters a daily use as a therapy or protocol for the specific pathology.
The first phase is called Preclinical. In this phase from the idea and from some initial tests in the laboratory or with animals, we try to understand if the idea can be effective. The typical duration of this phase varies between 3 and 5 years.
Phase I is the first phase in which the drug is tested on humans. Patients with cancer with therapeutic constraints are selected to identify the safest dosages, the most effective way of drug taking and the side effects. This phase typically lasts 1 or 2 years.
Phase II involves more patients with the specific tumor and the purpose of understanding to what extent the drug is effective. These studies can last a few months but typically less than 1 year.
In Phase III, more patients are involved and an attempt is made to determine whether treatment is more effective than standard treatments. Patients who are given the new drug and others to whom the standard drug is given are randomly chosen and the results are compared. This phase lasts on average from 4 to 5 years.
Once this phase is over, there is the Launch phase which decrees the drug as a new standard. To insert a new drug on the market it takes therefore from 8 to 15 years. The hope is that new technologies will reduce this duration or at least that of the Preclinical phase and increase the efficiency of the process by helping to select drugs that are more likely to pass all clinical phases.
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