Clinical Trials For Mesothelioma

Posted by : indra budiman | | Published in

What is a clinical trials? clinical trials is a research study activity that use humans as  "guinea pigs" to test some new developed treatment or drugs ( how it effects the disease ). Many breakthrough comes from this clinical trial, from a new treatment for dangerous disease to a newly curative drugs. Since it is just a trial , there are certain risks that a volunteer must take, a risk that would cost their live if the trial is fail, but if the trial is a success, the reward would be wort the while.

Some people choose to be a volunteer for this clinical trial for different reasons. Some people want to have more interactive involvement in the treatment that they receive, while some others want to have an active role in helping other people with their condition. People with mesothelioma disease often think " since there are no curative treatment or whatsoever for this disease might as well take the clinical trial because i don't have anything to lose, if its fail then so beat it". Those courageous people contribute greatly to the understanding of their condition and make an advance to medical sciences options for mesothelioma treatment.

Clinical Trials Phase

Generally there are 3 - 4 phase of clinical trials for any treatment or medication, these are the list of each phase :

Phase I   : The first phase usually a small trials, start by recruiting small amount of patients (30 or less patients) with no specification on the type of cancer that the patients have. This phase is considered completed when laboratory testing indicate that a new treatment might help in treat cancer. This phase is conducted to see :
  • The green zone dose range (safe range)
  • What are the side effects
  • How the patients body synchronize with the medicine
  • Is the treatment shrink the threat level of the cancer
The recruiting process of volunteered patients is slow on this first phase, so though there are only a few patients that volunteered, this phase take quite a time to complete. The first few volunteered patients that take part in this trials are  given a very small dose of the medicine. If things go well, then the next group of volunteer will be given a higher dose of medicine, so basically they will gradually increase the dose of the medicine for each new group of patients until they find the best dose that they should give to the patients. This is refereed as a dose escalation study.

On this first phase trial, patients may have a simultaneous blood tests, as the researchers study how your body react to the medicines that  are given, and how the medicine affecting the patients. Any side effects may be recorded.

The participant of this phase are often patients with advance cancer stage and they generally have try every treatments that are available. They may have an advantage by doing this first phase of the clinical trials if the medicine that were tested can reduce the sick state that they are in or not.

Phase II  : Not all the treatment that were tested from phase I trial are in phase II trial. Opposite from the first phase, this phase of trial generally being used for patients with the same type of cancer. This phase goals is to find out  :
  • The type of cancer that most effected by this treatment
  • Advance study on what are the side effects and how to manage it
  • Advance study on the best dose to use
  • If the new treatment works good enough to test in the next phase ( phase III )
Though treatment have been tested in the previous phase, there might be some side effects that the doctors don't know about since medicinal drugs can effects different people in different ways. The participant that take part in this second phase trials are more larger than the first phase ( up to 100 participant or more ). If the result of this phase indicate that the treatments that being tested are as good as the existing treatment or maybe better, then this phase is completed and may be move to phase III.

Phase III : This phase goals is to compare the best treatment that currently available with a new treatment that are being tested. This trials compare :
  • New treatment with the standard treatment
  • Different doses or ways of giving standard treatment
  • New radiotherapy with the one that currently available
Volunteer that participate in this phase are greater than phase I and phase II, this is because there are differences in success rate

Phase IV :  This phase will be conducted after a medicinal drug indicating a good result in recuperating cancer patients and have been given a granted license. This phase study at the medicines that are already prescribe by doctors rather than the one that are currently in development. Many pharmaceutical companies use this phase because :
  • Need more comprehensive data about the safety and side effects of the medicine
  • Need to know more about the long term risks and benefits of the medicine
  • Need to know how well the medicine works when its used more widely than in a clinical trials.