About clinical research studies

Clinical research studies provide important information
that helps researchers find and evaluate potential medicines and treatments.

Every approved medicine available on the market today has gone through clinical research studies to ensure it is safe and effective for treating diseases. These studies also help researchers understand how medicines work in the body. When a medicine is being evaluated in clinical research studies, it is called an investigational medicine.

Below is a general guide to the four key phases of clinical research studies:

Phase 1 – testing safety

Up to 100 people
Up to 12 months
Researchers assess an investigational medicine on a small group of people who do not have the condition the medicine aims to treat. This phase helps scientists understand how safe the investigational medicine is and how it interacts with the body.

Phase 2 – dose and effectiveness

Up to 300 people
Up to 2 years
Researchers assess an investigational medicine on a small group of people who have the condition the medicine aims to treat. This phase helps scientists understand which dose of the investigational medicine works best for treating the condition and continues to study its safety.

Phase 3 – large-scale testing

Up to 3000 people
Up to 4 years
Researchers assess an investigational medicine on a larger group of people who have the condition the medicine aims to treat. This phase helps scientists understand how well the investigational medicine works, monitor any side effects, and compare it to existing treatments. If the investigational medicine proves effective and safe during this phase, it may be approved for use in general clinical practice.

Phase 4 – real-world use

Researchers conduct studies after a medicine has been approved for use in general clinical practice. These studies occur over a longer period of time, with a larger group of people who use the medicine in real-world settings. This helps scientists learn more about the long-term benefits of the medicine and how it affects the body over time.

What happens in a clinical research study?

Clinical studies vary in length but can last up to five years, depending on the phase and design. Participants in a clinical research study go through several stages:

Informed consent stage:

Before enrolling in a clinical research study, participants are provided with detailed information explaining what is involved, including the risks/benefits of taking part, and are given the opportunity to ask questions. Participants are asked to sign a consent form to say that they had sufficient information and understanding before making the decision to take part.

Pre-screening stage:

During the pre-screening stage, researchers perform health checks, review medical records, and conduct tests to ensure participants meet the study criteria.

Screening stage:

Data is gathered before the clinical research study begins to understand participants’ conditions before starting the study. This helps researchers track any changes in participants’ health during the study.

Treatment stage:

This is the main part of the clinical research study where participants receive the investigational medicine. They visit the research site for tests; some studies may offer at-home visits. Tests may include blood tests, health check-ups, urine tests, pregnancy tests (if applicable), and questionnaires to assess the medicine’s safety and effectiveness.

Follow-up stage:

After participants finish the treatment, researchers continue to monitor their safety to ensure there are no long-term effects from the investigational medicine.

Participating in a clinical research study can provide insights into new treatments and contribute to medical research.

Potential participants should discuss any questions or concerns with the clinical research study team to fully understand what to expect and the potential benefits and risks involved.

What is a placebo/comparator medicine?

In clinical studies, investigational medicines are often compared to either a dummy medicine, known as a placebo, and/or a medicine currently used by doctors to treat patients, known as a comparator medicine. This helps researchers determine if the investigational medicine is effective.

What are the benefits of taking part in a clinical research study?

People choose to participate in clinical studies for various reasons, including personal, altruistic, and medical motivations:

Taking control of their healthcare:

Participating in clinical research studies allows individuals to engage in healthcare decisions actively. By joining a study, participants have the opportunity to contribute to the exploration of potential new treatments.

Contributing to future treatments:

Clinical research studies advance medical knowledge and improve treatments for others with the same condition. While there’s no guarantee of personal benefit, participating helps researchers learn more about the condition and develop better treatments for the future.

What are the risks of taking part in a clinical research study?

Everyone taking part in a clinical research study is monitored very carefully and cared for should any side effects occur. Potential risks will always be explained by research staff and could include:

Experiencing unpleasant or serious side effects from the investigational medicine.
Finding that the investigational medicine does not effectively manage your condition.
Being assigned to a control group where you receive standard treatment or a placebo instead of the investigational medicine.
Needing to make extra visits to the study site, undergo additional treatments, or stay in the hospital.

Is it safe to take part in clinical research studies?

Clinical studies prioritize the safety of participants through strict regulations and guidelines:

Approval process: Clinical studies must receive approval from medical review boards and independent ethics committees before starting.
Monitoring and care: Participants are closely monitored throughout the study, and suitable care is provided if any side effects occur.

Government regulations: Clinical studies follow strict rules enforced by government authorities to ensure safety and ethical standards.
Voluntary participation: Participants can stop participating in the study at any time.

Why is diversity important in clinical trials?

Diversity is important in clinical trials to make sure the research accurately reflects the people it aims to serve. It’s also important to understand how a potential medicine affects people of all ages, genders, and ethnic backgrounds, as responses to potential medicines can differ among these groups. Some ethnic communities may also have a higher incidence of particular conditions, or they may be more susceptible to a specific type of condition. Often, these communities are underrepresented in clinical trials. This leads to a lack of understanding of how effective the medicine will be for those who aren’t included in clinical trials.

We welcome participants from all backgrounds who meet the ARIA study’s requirements. We are committed to ensuring that clinical study participants represent the diverse population affected by asthma.