What is a clinical trial? Let's talk about this simply!

Have you ever heard the word 'clinical trial'? Maybe you've seen it in a movie or in a newspaper. Some people think it's a big, scary thing. But in fact, many of the medicines and treatments we use today were created because of research like this. Without them, new, life-saving medicines wouldn't be available. So, today we're going to talk about what a 'clinical trial' is, what it is, how it's done, and what the benefits and risks are.

Simply put, what is a clinical trial?

It's very simple. A clinical trial is a medical research study involving people who volunteer. These are the only way to find out if a new treatment really works and if it's safe for people to use.

This research can be about a variety of things.

• About a way to discover a new disease.
• About a way to prevent getting sick.
• About a new medicine, a combination of several medicines, or a new medical device.

In this article, we will mostly talk about research into new treatments. Sometimes, because you have a medical condition, you may want to get involved as a way to get a new treatment for it. Also, healthy people who are not sick at all volunteer to help advance medical science and help others who are sick.

What happens before starting a research project?

A clinical trial cannot be started all at once. There is a long process before that. Think of it like researching the route, checking the car, and getting everything ready before going on a long trip.

• Preclinical tests: All research begins with an idea. That is, an idea like "This new drug will work for this disease." Then this drug is first tested in the laboratory (laboratory tests) and sometimes in animals (studies in animals).
• Clinical trial protocol: If the initial tests show that the new treatment has a chance of success, the researchers then create a very detailed plan. This is called a ``protocol.'' It should clearly state why the trial is being conducted, what treatments are being tested, and what the ``trial endpoints'' are expected to measure at the end of the trial.
• Obtaining approval: Before conducting a research involving people in our country, or anywhere in the world, approval must be obtained from the health authorities in that country (for example, from institutions like the National Medicines Regulatory Authority - NMRA in Sri Lanka) and a special ethical committee (Institutional Review Board - IRB or Ethics Committee) of the hospital or institution conducting the research. The main purpose of this committee is to ensure the safety and rights of your participation in the research.

Only after all of this approval has been received can researchers begin looking for people who are willing to participate.

A very important thing: Informed Consent

If you're thinking about joining a clinical trial, this is the most important step. It's not just a piece of paper you sign. It's a detailed discussion between you and the research team.

During this ``Informed Consent'' process, the research team explains everything to you.

• What are the objectives of the research?
• What treatments are available to you?
• How long has this been going on?
• What are the risks and benefits you might experience?
• What other treatments are there that you can get that are not related to this?
• Will it cost you anything?
• How do you keep your personal information confidential?

You will be given a document with all of this information to read. It can be a bit complicated, so don't be afraid to ask any questions you have, no matter how small.

Some trials are ``randomized.'' That is, they randomly decide whether you get the new drug or the current standard treatment, like flipping a coin. This is also something you should be aware of beforehand.

Phases of a Clinical Trial

There are typically four main phases of research into a new drug. Each phase has a different objective, and new volunteers are recruited for each phase.

What are the benefits and risks of participating in a clinical trial?

As with anything, there are benefits as well as risks. All of this will be explained to you during the ``Informed Consent'' process.

Potential Benefits

• Access to the latest treatments: You may have the opportunity to receive the latest treatments that have not yet reached the general market, which may be more successful than existing treatments.
• More control over your health: Learn more about your condition and treatment, and work closely with your medical team.
• Helping others: Your participation could help thousands of people with the same condition as you in the future. By participating as a healthy person, you are making a significant contribution to the advancement of medical science.

Potential Risks

• Side effects: New experimental treatments may cause unexpected side effects, which may require medical treatment.
• More time and commitment: You may have to come to the hospital more often, have tests, and even stay in the hospital longer than usual for treatment.
• Treatment failure: The new treatment may not work for you, or it may not be any better than the current standard treatment.
• Not getting the new treatment: In a randomized trial, as we discussed earlier, you may receive the current standard treatment instead of the new treatment, or perhaps a placebo that contains no active medication.

Some questions you should ask

Before joining a clinical trial, you may have a lot of questions. That's normal. Here are some important questions you can ask the research team.

• Why is this research being done?
• How long do I have to be involved in this?
• If I am receiving treatment, how will it be given (as a pill, as an IV, or some other method)?
• How many times will I have to come? Where do I have to come?
• How long does it take to get there once?
• Will I have to pay for anything in this research?
• What are the risks? How could it affect my health?
• If I don't join this or leave halfway through, what will happen to my regular medical care?
• Who is responsible for my medical care?
• Will I be informed about the results of this research?
• If this treatment is successful and approved, can I continue to receive it?
• If I experience severe side effects, can I withdraw from the study?

What is the difference between a clinical trial and regular treatment?

This is something that many people are confused about. If you are participating in a clinical trial because of a medical condition, your usual health problems (e.g., diabetes, high blood pressure) will continue to be taken care of by your regular doctor and medical team.

The team in charge of the clinical trial focuses solely on the new drug or treatment being tested. They monitor your body's response to the new treatment and treat any side effects that may occur. This means you will receive care from two medical teams.

Ultimately, clinical trials are the engine that drives medical science forward. While they may seem like science to the outside world, at their heart are people who volunteer to help improve medical treatments. Without them, researchers would never be able to determine whether a new drug is safe or effective.