A clinical trial is the process after conducting laboratory research to find out if a drug is safe and effective enough to research on people.
Drugs first have to be created, discovered, cleansed, characterized, and tested in cell and animal studies. Second, most drugs have at least 6 years of laboratory research behind them before they even make it to a clinical trial. Drugs sometimes take up to 8 years from when they enter the clinical trial until they are FDA approved.
Each new treatment is looked at in many different studies and is tested on only those patients who specifically qualify to take part in the trial.
This is the first step in trying a new drug in a person. Phase I groups are normally small and as the phases move up so do the sizes of the groups. To begin with, the physician will start the participant with the lowest dose of the drug. The physician will monitor the participant frequently to see if there are any adverse reactions and how long the drug stays in the participant's system. Once this first dose is determined to be safe, the physician will slowly increase the dosage until the most effective and safest amount is determined.
An example of the process:
The physician finds a participant that fulfills all recommended requirements for the study. The participant agrees to take part in the study, is given the lowest dose of the drug possible, and is monitored regularly for a set amount of time. During the time that the first participant is being monitored, the drug may have been determined safe. The physician finds another participant with the same diagnosis and who meets all requirements for the study. The participant agrees to the study, is given the next highest dose, and is monitored. If no adverse reactions , the steps continue until the physician has determined the most effective and safest dose to give patients with this disease.
Generally this group is a little larger than the phase I group. These participants receive the dosage that was found to be the most effective and safest in the previous phase. Participants are given the drug to determine its effectiveness in treating the disease. Sometimes the group is broken up and given a different regimen of the drug. Regimens may consist of different doses of the drug and/or different types of treatment with the drug. This is done to determine which treatment is most effective in treating the disease. If the drug proves to be beneficial for the study patients, the next step for the drug is to go to Phase III.
This is the phase that if the drug passes it will be approved by the FDA for a standard treatment. The group in phase III is substantially larger than the previous two. Typically the group will be split into two sections. One group will receive treatment with the new drug and the other group will receive treatment with the standard drug. Often times the participants are masked and dr. are unable to choose what drug the patient will be administered. This allows for a more accurate result.
An example of this process:
Patients who are further progressed in a disease may all wish to have the new treatment, whereas those patients who are not as far progressed may all wish to stick with the standard treatment . This will distort the perception of the treatment and the true results of the treatment. In order to see what the treatment is capable of and to have a clearer picture, groups and the dr. are often blinded as to which treatment will be used.
The FDA has already approved the drugs and treatments in this phase for public use. This phase looks at the possible long-term side effects of approved drugs and treatments.
Integrated Clinical Research, LLC
dba Retina Research Institute of Texas
Sunil S. Patel, M.D., Ph.D.
S. Young Lee, M.D.
5441 Health Center Dr.
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