Clinical Trials

All new medical drugs and treatments must go through clinical trials before they can be considered safe for use in the general population. Therapies and drugs that have become standard in the current medical industry use have been through extensive clinical testing before becoming widely used.

These types of trials can be a source of hope and encouragement for people who have treatment-resistant, aggressive, and nearly incurable diseases such as mesothelioma. When considering taking part in a clinical trial, however, it’s very important to remember that taking part does not by any means guarantee the treatment will improve your health.

The Clinical Trial Process

Any given clinical trial includes three different stages, or phases.

· Phase One: A limited number of people are enrolled, and the trial mainly involves determining the most safe and effective dose to use of a new drug.

· Phase Two: A larger number of people are enrolled in this phase, where the efficacy of the drug in treatment of a particular illness is tested. In this phase, all that is tested is whether or not the treatment actually works.

· Phase Three: The goal here is to show the experimental treatment is more effective than existing treatments. In this phase, the new drug is compared to existing treatments for the disease.

If a new drug passes through all three phases successfully, it may be approved for use amongst the general public, and may become part of the established standard of care for the disease it is designed to treat.

How can you find out About Clinical Trials?

There are several sources of information about clinical trials. Your first point of call may be the internet, where you can find resources about clinical trials being carried out all over the country. The National Institute of Health (http://clinicaltrials.gov/) and the National Cancer Institute (http://www.cancer.gov/search/clinical_trials/) provide databases that can be searched for information about clinical trials.

Second, you can consult your doctor, who will be able to help you access information about specific trials, and help you determine if you meet qualifying criteria for trials you are interested in. Finally, you can also contact regional cancer centers in your area, which may have information about clinical trials being carried out in hospitals with which they share an affiliation.

What Should You Expect at a Clinical Trial Screening?

Not everyone who applies for entry to a clinical trial will be accepted. The primary purpose of a clinical trial is to collect information about a particular drug used in the treatment of a particular disease. To make the information-gathering process as accurate as possible, the people who take part in a clinical trial have to be chosen very carefully.

This is done to control what are called “variables” in the clinical trial, which are all the various characteristics that make each person in the trial different. In a clinical trial, the aim is to remove as many variables as possible, as these can potentially affect the results of a trial, and pose difficulties in establishing the effectiveness of the experimental treatment.

This means that in a clinical trial for mesothelioma, the trial may only accept people with a particular kind of mesothelioma that is in a particular stage. For example, the trial might only accept people with pleural mesothelioma in stage two, but not people with peritoneal or pleural mesothelioma in any other stage. The trial may also accept people based on the type of treatment they have received. For example they might only accept people who have not received any treatment, or who have not received a particular kind of treatment (such as surgery or chemotherapy).

General health is also a consideration, in that clinical trial coordinators will generally only accept people who don’t have any other pre-existing medical conditions, and who are not taking medications. Again, this is done to control the variables in the trial—don’t take it personally if you apply to enter a clinical trial and are not accepted.

Points to Consider before Participating in a Clinical Trial

If you are thinking about participating in a trial, there are several different important factors to consider besides whether or not you will be accepted into the trial. The following are some questions you can ask the trial coordinator during the screening process.

· What is the trial testing?

· What treatments are being used?

· What potential risks and side effects are there?

· What were the results of any previous trials that used this treatment?

· How long will the trial last?

· How often are treatments administered, and how long will treatment take?

· Will I have to cover any of the costs of treatment?

· Will I have to be hospitalized, or will the treatment be out-patient?

Another very important consideration is that you lose control over your medical treatment. In some clinical trials, not all patients receive the experimental treatment—some receive an existing standard treatment, and some receive a placebo, which essentially means they receive no treatment at all. If you participate in a trial like this, you cannot choose and will not know which type of treatment you are given.

One particular benefit of a clinical trial, however, is that you will receive excellent medical care throughout the trial. You will also be participating in an event that may help produce a new and more effective treatment for mesothelioma.