It's hard to put into words the fear, shock, and uncertainty you feel when you're diagnosed with breast cancer. At this point, you probably have a lot of questions in your mind. "What do I do now?", "What treatments are available?", "Will I get better again?" Things like that. During this journey, when talking to your doctor, you may hear the word " Clinical Trial ". You may have seen it in the newspaper or on TV. So today, let's talk about what this Clinical Trial is, which many people are afraid of but don't really know.
Why do we conduct clinical trials like this?
Simply put, a clinical trial is a medical study that is conducted to find better, more advanced ways to treat diseases like breast cancer. This could be a new drug, a new surgical procedure, or another alternative treatment.
The doctors conducting this research are comparing the best current treatments with this new treatment. Through this, they are looking for answers to questions such as:
- Is this new treatment safe ? Does it have good results?
- Could this be better than current treatments?
- What are the side effects of this treatment?
- Is there any risk in this?
- How successful is the treatment?
- If it's a new drug, what is the maximum dose the body can tolerate?
It is only after examining all of this that a decision is made as to whether a new treatment is appropriate for everyone in general.
Are there different types of clinical trials?
Yes, every clinical trial is conducted in several phases. The information obtained in one phase is used in the next phase. Depending on your health condition, it is decided which phase of research is suitable for you. Most people participate in the third phase (Phase III). Let's take a closer look at this phase.
| Phase | Main objective | Number of participants (by appointment ) |
|---|---|---|
| Phase I | Ensuring the safety of a new treatment. In the case of a drug, the safe dose, how it is given (by mouth or by injection), and how often it is given are investigated. | Very small number of people (e.g. 20-80) |
| Phase II | Once the treatment is confirmed to be safe, it is tested to see if it is effective for a particular type of cancer. | Less than 100 people |
| Phase III | The new treatment is compared with the current standard treatment to determine which is best. | A large group of people (hundreds or thousands) |
Treatments that are successful in Phase III are usually approved for general use by world-class institutions (e.g. FDA - Food and Drug Administration).
Advantages and disadvantages of participating in a clinical trial
Like any other option, there are pros and cons to this one. It's important to understand both sides before making a decision.
| Advantages | Disadvantages |
|---|---|
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Are these really safe? Will they make me a 'fire pig'?
This is the biggest fear in the minds of many people. The fear of "will I be used like a lab rat?" is reasonable. But the truth is much different.
A clinical trial is not about putting you through an experiment. It is about doing something under very strict rules and safety procedures, with your safety as a top priority.
- Confidentiality: All personal information collected about you is kept strictly confidential . Nothing including your name will be published.
- Close monitoring: You will be closely monitored by doctors and nurses. They will check your condition more often than usual. They will always check for any unexpected side effects.
- Safety Boards: Every clinical trial is overseen by an independent ethics review board (Investigative Review Board). Their main job is to ensure the safety and rights of volunteers like you who participate.
- Right to withdraw: Most importantly, you have the right to withdraw from this study at any time . If your doctor or you feel that it is not right for you, you can withdraw without any problem. It will not affect any other treatment you may receive.
How do I get involved in this kind of research?
Participating in a clinical trial is entirely voluntary . Even if your doctor suggests it, the final decision is yours. Informed Consent is very important in this process.
"Informed Consent" simply means "informed consent." It means that before you participate, you will be given all the information you need to know about this research.
- Purpose of the research
- What treatments and tests are done?
- What are the potential benefits and risks?
All of this will be explained clearly and you will be given an Informed Consent Form to read and understand. Read it carefully, think about it, and ask the doctor or nurse any questions you have. Once everything is clear, sign it only if you are comfortable with it.
You are not bound by this by signing. Even after signing, you are free to withdraw at any time during the research.
Questions you should definitely ask your doctor
If you are being talked to about a clinical trial, be sure to ask these questions.
- What is the main purpose of this research?
- What tests and treatments will I need to have? How will they be done?
- What might my condition be like with and without this new treatment?
- What are the standard treatments for my condition? What is the difference between them and this research?
- How will participating in this affect my daily life ?
- What side effects can I expect?
- How long has this research been going on? Will I have to spend more time on it?
- Will I have to stay in the hospital ? If so, how often and for how long?
- If I decide to withdraw midway, will it affect my treatment? Will I have to change doctors?
Take-Home Message
- A clinical trial is a very important medical research conducted to find better, more advanced treatments for diseases like cancer.
- Participation in this is entirely voluntary. You have the right to withdraw at any time.
- Your safety is our top priority , and you will be closely monitored by doctors. You will not be turned into a "fire pig."
- Before making a decision, talk to your doctor thoroughly , ask all your questions, and understand both the pros and cons.
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