WHAT ARE CLINICAL TRIALS?

Clinical trials are carefully planned research studies. Sponsors of clinical trials include companies, universities, and healthcare institutions who initiate and support the research.

In clinical trials, scientists study medicines and their effects on healthy people or those who are dealing with a particular condition. The people who participate in clinical trials are dedicated volunteers.

Personnel (Doctors and non MD’s) who are trained in conducting clinical trials are the principal investigators. They carry out the research study and interact with study participants. There are other members of the research team that also help to coordinate the trial.

Before each trial begins, the research team establishes a strict plan, also called a protocol. This includes:

What is known about the disease and the medicine in the study
Why the is study being done and what question(s) will be answered
What tests and procedures will be performed
The study design and methods to test the questions being asked
How often study participants will be examined or evaluated

When it comes to creating new medicines, clinical study play an important role. However, several key steps must first take place before a clinical trial can even begin.

Discovery and Development

In this step, which can take years, early laboratory research helps reveal which drugs demand further study.

Preclinical Research

Before those drugs can be tested in people, this step helps investigators learn about a drug’s basic safety. This helps to understand some potential to cause serious harm. The studies done during this step are usually not very large in size. They help doctors learn the correct dose of the drug to give to people and more about the drug’s potential harmfulness, and are designed to gather detailed information on a drug’s dosing and potential level of toxicity (potential harmfulness).

Clinical Research

Although preclinical research answers important questions about safety, it doesn’t tell us how a drug will affect the human body. This is when Clinical Research comes into play. Clinical research uses trials or studies to help answer these questions, and are conducted in human participants.

WHAT ARE THE PHASES OF CLINICAL TRIALS?

Clinical trials take place in phases. Each one serves a different purpose and helps researchers answer very specific questions. The amount of time and the number of people involved is different in each phase to ensure that the drug in development is safe and effective and that the research can continue. Regulatory authorities must approve the results from each phase before the next one can begin.

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Pre-Clinical Development

Phase 1

Phase 2

Phase 3

Phase 4

Before clinical trials can be done with human participants, researchers study investigational treatments in the lab.
This stage reveals if the drugs should be studied more.
Once the researchers have enough information, they ask for permission to do clinical trials from the government and independent groups called ethics committees.

Small Sample Size

Healthy Volunteers

Usually the first time a new investigational treatment is studied in humans.
Learn if a new investigational treatment is safe enough to keep studying in other phases
Evaluate safety issues, including dose range, side effects, and how the drug works in the body
Usually take several months to complete
Usually includes less than 100 participants

Approximately 70% of drugs in a Phase 1 trial will move on to the next phase.

Test the safety of a new medicine

Test for side effects

Define the right dose

Larger Sample Size

Including those with the condition or disease

Learn if a new investigational treatment helps people who have a condition
Usually take several months to several years to complete
Usually include participants who already have the disease or condition for which the drug is being developed
Usually includes 100-300 clinical trial participants

Approximately 33% of drugs in a Phase 2 trial will move on to the next phase.

Test for its effects in the short therm

Compare a new medicine against an existing treatment/placebo

Monitor side effects

Larger Sample Size

Including those with the condition or disease

Help confirm how well the drug works and to monitor side effects
Provide the majority of a drug’s safety data
Usually take several years to complete
Usually includes 300-3,000 clinical trial participants

Between 25% and 30% of drugs in a Phase 3 trial will move on to the next phase.

Compare a new medicine against an existing treatment/placebo

Test for side effects

See if it’s better

Once a new medicine has passed all previous phases and has got a marketing licence.(marketing licence = a medicine can be available on prescription)

Larger Sample Size

(involving people being treated over several years and in different places)

Occur after a medicine is approved by regulatory authorities and is available for patients.
These trials take place over many years.
They are conducted to further learn how effective a treatment is when it is a part of everyday life.
Allow researchers to monitor a drug’s risks and benefits, as well as optimize its use.

Monitor its safety

Monitor side effects

Monitor its effectiveness

Will be continuously studied while it's being used in practice

WHAT TO EXPECT WHEN PARTICIPATING IN A CLINICAL TRIAL

There are several parts in each clinical trial. While volunteers receive treatment during the main part, there are other important parts to consider..

PRE-SCREENING

You talk with the trial team to learn about the trial treatment. The trial team asks questions to make sure you meet the “eligibility criteria”. These are a set of requirements specific to the trial. Every trial has its own requirements. Eligibility criteria are used to make sure that the trial population can help answer the main questions in the trial.

INFORMED CONSENT

You review an informed consent form that explains your rights and responsibilities. You ask any questions that you may have. If you decide to join the trial, you will need to sign the form. It’s important to know that this form is not a contract — you can withdraw from the trial at any time.

SCREENING

The trial doctor reviews your medical history and does a physical exam. He or she may do other tests or measurements to make sure you can participate.

ENROLLMENT

You join the clinical trial. The trial team explains what will happen during the trial.

TRIAL PARTICIPATION

You receive the trial treatment. The visits to the research center may be days, weeks, or months apart. They may include physical exams, questionnaires, or other tests and measurements. You will have a schedule to follow. Some of the visits and tests may be similar to your usual care, but some will be specific to the trial. These visits and tests are needed to find out how the treatment is going and to check on your health.

END OF TREATMENT

The trial team may follow up with you to see how you are doing after ending treatment. Sometimes a trial is ended early by the company running the clinical trial. If this happens, the trial doctor will tell you and help you end the trial safely.

It is important to remember that you can leave the trial at any time for any reason. However, you should always talk to your trial doctor before you stop.

WHY JOIN A CLINICAL TRIAL

All participants are important to a clinical trial. Clinical Trial participants help researchers answer important health questions. These answers may help lead to the discovery of new medicines, which provides a unique opportunity to contribute to science.

UNDERSTANDING THE POSSIBLE BENEFITS AND RISKS OF PARTICIPATING IN A CLINICAL TRIAL

The results of every clinical trial are important because they give researchers more information about the risks and benefits of the treatments in the trial. These findings can go a long way toward informing future medical advances. As you consider taking part in a clinical trial, you should consider the following risks and benefits.

POSSIBLE BENEFITS

Access to potentially new study medications, therapies or devices that are not otherwise available
Getting an experienced team of healthcare professionals to closely monitor and care for your condition
Learning more about your own disease or condition
Helping to make a difference in the lives of others affected by the same disease or condition

POSSIBLE RISKS

The treatment being studied is not always better than other treatments or no treatment
Investigational treatments might have side effects that are not expected
Participants in some trials cannot choose the treatment they receive
Health insurance and managed care providers may not cover all of participant’s costs in a clinical trial
Participants may need to visit the doctor more often than if they were not in a clinical trial

Please talk to your doctor about study specific benefits and risks

As with any decision that affects your health, it’s important to discuss the benefits and risks of clinical trial participation with your healthcare provider. The decision of whether or not to participate is ultimately yours, so it’s important to make sure that you understand everything that is involved. It’s also important to know your rights as a clinical trial participant. Ethical guidelines are in place to protect trial participants while science moves forward. Remember, as a clinical trial volunteer, your participation is just that—voluntary. That means that you can leave a clinical trial at any time.

Carefully consider the benefits and risks for each clinical trial. Talk with your healthcare provider, your family, and the research team. Ask questions and discuss your concerns. The more you know about clinical trials, the better prepared you will be to participate and receive the care you expect.

NOTE: Looking for more resources on clinical trials? Click here to go the resources section of our website.