Understanding Clinical Trials
Updated February 09, 2015.
Clinical trials, sometimes known as clinical studies, are conducted in order to test new ways in which to prevent, diagnose, treat, or monitor prostate cancer. Clinical trials involve the use of human volunteers to test new methods before these methods are approved for use by a broader range of patients.
While there is not always a “best” kind of clinical trial, within the medical research community the “gold standard” (or very best type of) study is the double-blind randomized controlled trial.
This study provides the most clear-cut information about whether a particular treatment or other intervention is better than no treatment (placebo) or a currently accepted treatment.
In this type of trial, patients are randomized or arbitrarily assigned (usually by a computer) to either a treatment or a placebo group. The trial is described as double-blind because neither the patient nor the doctors are aware of who is receiving the actual treatment and who is receiving a placebo. This greatly reduces the odds of bias creeping into the study and warping the results.
First of all, it is important to understand that everyone involved in a clinical trial who is afflicted with a certain disease, such as prostate cancer, will receive at least the basic, standard treatment for that disease.
Most clinical trials split volunteers into groups which receive different treatments. One group typically receives a new, unproven treatment that researchers believe shows promise and another group receives a standard, accepted treatment.
This allows for a direct, head-to-head comparison of treatment options.
Some types of trials work differently however. In some trials that involve healthy patients, roughly half of the patients in a study will receive a placebo instead of the actual medical therapy being studied. A placebo is something given to a patient that is similar in every way to the treatment that is being tested, except that a placebo has no actual medical properties. For instance, a “sugar pill” can be used as a placebo instead of a pill with actual medical attributes (such as aspirin).
There are four “phases” of clinical trials. Phases I through III (one through three) are completed before a new treatment or other intervention is marketed and made available to the general public. Phase IV (four) is conducted after the treatment has been released to the general public.
Finding a clinical trial that you may be eligible to enroll in can be difficult. The National Cancer Institute (NCI)and CenterWatch keep updated lists of prostate clinical trials. These sites are great places to begin your search for an appropriate clinical trial.
Finally, the National Institutes of Health (NIH) has created an excellent resouce to properly understand what enrolling in a clinical trial entails and what you should consider before doing so.
What Is a Clinical Trial?
Clinical trials, sometimes known as clinical studies, are conducted in order to test new ways in which to prevent, diagnose, treat, or monitor prostate cancer. Clinical trials involve the use of human volunteers to test new methods before these methods are approved for use by a broader range of patients.
What Is the Best Kind of Trial?
While there is not always a “best” kind of clinical trial, within the medical research community the “gold standard” (or very best type of) study is the double-blind randomized controlled trial.
This study provides the most clear-cut information about whether a particular treatment or other intervention is better than no treatment (placebo) or a currently accepted treatment.
In this type of trial, patients are randomized or arbitrarily assigned (usually by a computer) to either a treatment or a placebo group. The trial is described as double-blind because neither the patient nor the doctors are aware of who is receiving the actual treatment and who is receiving a placebo. This greatly reduces the odds of bias creeping into the study and warping the results.
Does Everyone in a Clinical Trial Receive Treatment?
First of all, it is important to understand that everyone involved in a clinical trial who is afflicted with a certain disease, such as prostate cancer, will receive at least the basic, standard treatment for that disease.
Most clinical trials split volunteers into groups which receive different treatments. One group typically receives a new, unproven treatment that researchers believe shows promise and another group receives a standard, accepted treatment.
This allows for a direct, head-to-head comparison of treatment options.
Some types of trials work differently however. In some trials that involve healthy patients, roughly half of the patients in a study will receive a placebo instead of the actual medical therapy being studied. A placebo is something given to a patient that is similar in every way to the treatment that is being tested, except that a placebo has no actual medical properties. For instance, a “sugar pill” can be used as a placebo instead of a pill with actual medical attributes (such as aspirin).
What Types of Trials Are There?
There are four “phases” of clinical trials. Phases I through III (one through three) are completed before a new treatment or other intervention is marketed and made available to the general public. Phase IV (four) is conducted after the treatment has been released to the general public.
- Stage I trials involve testing the treatment in a small number of people in order to establish a safe dosage and to look for any side effects or problems with safety.
- Stage II trials involve testing the treatment in a somewhat larger group of people in order to determine if the treatment is effective and to further look for side effects.
- Stage III trials involve testing the treatment in a much larger group of people in order to be sure of its effectiveness, collect more information about its side effects over a longer period of time, and compare its results with treatments that are already available.
- Stage IV trials involve a very large group of people who have used the treatment following its marketing and release to the public. This allows for a broader range of patients to be studied for any long-term side effects or other problems.
Finding a clinical trial that you may be eligible to enroll in can be difficult. The National Cancer Institute (NCI)and CenterWatch keep updated lists of prostate clinical trials. These sites are great places to begin your search for an appropriate clinical trial.
Finally, the National Institutes of Health (NIH) has created an excellent resouce to properly understand what enrolling in a clinical trial entails and what you should consider before doing so.
