Has your doctor ever told you or someone in your family about a 'clinical trial', a new medical research project? It's normal to feel a little scared and curious when that happens. "Will this do me any good? Will it cause any harm?" Many questions probably come to mind. When people hear this word, they think they're being used as a "fire pig." But that's not really the case. So today, let's talk very simply and clearly about what a clinical trial is and what it entails.
Simply put, what is a clinical trial?
Simply put, this is when a team of scientists and doctors come together to test a new drug, treatment, medical device, or new way to diagnose a disease on a group of people to see how effective and safe it is. The main goal is to find treatments that are more advanced, effective, and safer than existing treatments.
Just think, some serious illnesses may not be cured by current conventional treatments. At such times, new research like this could be very useful for you.
These new treatments are not given to people all at once.
1. First, these are subjected to very rigorous testing in laboratories.
2. Then, experiments are conducted using animals.
3. Only if the treatment is proven safe and effective in these first two phases will human trials begin. But first, it will be given to a small group and then to larger groups.
Through this research, doctors are seeking answers to questions like:
- Is this treatment safe? Is it effective?
- How good a result will this give?
- Is this better than current treatments?
- What are the side effects and risks of this treatment?
What are the phases of this research?
There are several main stages, or "phases," in a clinical trial. The information obtained in one phase builds on the information obtained in the next phase. Depending on your health condition or the severity of your disease, you may be selected for a specific phase. Typically, most patients participate in Phase III or IV.
| Phase | What's going on here? |
|---|---|
| Phase I | Doctors test the new treatment on a very small group of people (healthy volunteers or patients) to determine its safety . They look for a safe dosage, the best way to give the drug, and what side effects it may cause. |
| Phase II | Here, researchers look at how well this treatment works for a specific disease. This involves a larger group of people than in the first phase. |
| Phase III | This involves comparing the new treatment with the standard treatment currently in use. It also looks at how the treatment works in different populations (e.g. men, women, young people, older people) and at different doses. A large group of patients participate in this phase. |
| Phase IV | In this phase, even after the treatment has been approved and released to the market, information is collected about it. The aim is to find out how effective the treatment is in the long term and whether there are any rare side effects that were not identified in earlier phases. |
What are the benefits of joining a clinical trial?
- Opportunity to receive the latest treatment: You may have the opportunity to receive the latest, most advanced treatment before it is available to the general public.
- Help for the future: The information you provide will greatly help researchers develop better treatments that will help thousands of other patients in the future.
- Cost reduction: Many of the costs of tests and doctor visits related to research are usually covered by the organization sponsoring the research. However, it is important to discuss this clearly with your medical team before participating in the research.
Can this kind of research cause problems?
Yes, as with any treatment, there are some risks. The extent of the risk depends on the nature of the treatment and your general health.
The main thing is that because these treatments are still in the research stage, scientists don't fully know how they will affect your body. Therefore, there may be a higher risk of unknown side effects than with already established treatments.
What is Informed Consent?
This is the most important part of a clinical trial. Before you are included in the research, the doctors and nurses will explain the treatment to you fully, including its potential benefits and risks. They will give you the opportunity to ask any questions you may have.
Once you fully understand all of this, you will be asked to sign a document stating your willingness to participate in the research. This process is called "Informed Consent".
Remember, signing up does not bind you to this research. You have the full right to withdraw from this at any time, for any reason.
Also, this awareness process does not end in one go. If new information about the treatment becomes available during the research, the medical team is committed to continuing to inform you of all that information.
Questions you must ask before making a decision
If you're thinking about participating in a clinical trial, make sure you learn as much as you can before making a decision. Here are some questions you should definitely ask your doctor:
- What is the real purpose of this medical research?
- What tests and treatments are included in this research? How will they be given?
- Without this new treatment, what will my condition be like with standard treatment? How does this compare to current treatment?
- How will this research affect my daily life?
- What side effects can I expect?
- How long will this research take? Will I need to dedicate extra time to it?
- Will I have to stay in the hospital? If so, how often and for how long?
- If I decide to withdraw from the research, will it affect my treatment? Will I have to change doctors?
Take-Home Message
- A clinical trial is a scientific study conducted to find better, safer, and more effective treatments than currently available.
- There are several phases to this. The objectives of each phase are different.
- The benefits include receiving the latest treatments and helping the future. There is also the risk of undetected side effects .
- Informed consent is more than a signature. It is a process based on full explanation.
- You can withdraw from the research at any time, without any repercussions.
- Before making a decision, feel free to discuss all your concerns with your doctor.
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