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Sunday; 18 September 2011
July 2011
In view of the upcoming Head & Neck Symposium at Pantai Hospital Kuala Lumpur on 30th July 2011, Dr John Low provided the background and context about the overall theme, namely the multidisplinary care as well as its content.
Venue : Dewan Pantai, Pantai Hospital Kuala Lumpur
Clinical Trial at Pantai Hospital Kuala Lumpur
Introduction
If you have cancer, you may want to think about taking part in a clinical trial. Clinical trials are a treatment option for many people with cancer.
Clinical trials are research studies that involve people. They are the final step in a long process that begins with research in a lab and animal testing. Many treatments used today are the result of past clinical trials.
Clinical Trials Take Place in Phases
For a treatment to become part of standard treatment, it must first go through 3 or 4 clinical trial phases. You do not have to take part in all phases. The early phases make sure the treatment is safe. Later phases show if it works better than the standard treatment.
| Purpose | Number of people who take part |
| Phase I | |
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To find a safe dose. To decide how the new treatment should be given. To see how the new treatment affects the human body. |
15-30 people |
| Phase II | |
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To determine if the new treatment has an effect on a certain cancer. To see how the new treatment affects the human body. |
Less than 100 people |
| Phase III | |
| To compare the new treatment (or new use of a treatment) with the current standard treatment. | From 100 to thousands of people |
| Phase IV | |
| To further assess the long-term safety and effectiveness of a new treatment. | Several hundred to several thousand people |
Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the study, called a protocol, which is like a recipe for conducting a clinical trial.
The protocol explains what the trial will do, how the study will be carried out, and why each part of the study is necessary. It includes information on:
- The reason for doing the study.
- Who can join the study.
- How many people are needed for the study.
- Any drugs they will take, the dose, and how often.
- What medical tests they will have and how often.
- What information will be gathered about them.
Common criteria for entering a trial:
- Having a certain type or stage of cancer.
- Having received a certain kind of therapy in the past.
- Being in a certain age group.
Criteria such as these help ensure that people in the trial are as alike as possible. This way doctors can be sure that the results are due to the treatment being studied and not other factors.
These criteria also help ensure:
Safety - Some people have health problems besides cancer that could be made worse by the treatments in a study. If you are interested in joining a trial, you will receive medical tests to be sure that you are not put at increased risk.
Accurate and meaningful study results - You may not be able to join some clinical trials if you already have had another kind of treatment for your cancer. Otherwise, doctors could not be sure whether your results were due to the treatment being studied or the earlier treatment.
If you decide to participate in clinical trial, you may contact Pantai Cancer Institute at number 03-2296 0800 for more details.
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