About Clinical Studies

A clinical study (also known as a clinical trial) is a carefully controlled scientific investigation that helps us answer questions about an investigational drug, such as:

  • Is it safe?
  • Does it work?
  • Does it work better than another treatment?

What are the different phases of clinical studies?

There are 4 main phases of clinical studies – with 1 being the earliest and 4 being the latest. The FENtrepid Study is a phase 3 clinical study.

Phase 1


To assess the initial safety of an investigational drug in a small number of participants


(usually 20-80 healthy individuals)

 

Phase 2


To evaluate safety and efficacy by testing it on a larger group of participants


(usually 100-300 individuals)

 

Phase 3


To assess safety and efficacy on an even larger number of participants; often tested against any existing treatments


(usually 1,000-3,000 individuals)

 
Approved for use
 

Phase 4


To collect information about safety and efficacy in a “real-world” setting following a drug’s approval for use

An investigational drug generally enters the next phase if it meets the objectives of the previous phase(s).
Sometimes, more than one study must be conducted per phase.

Why take part in a clinical study?

There may be some risks or discomforts involved in taking part in a clinical study, for example:

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Regular health monitoring throughout the study

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Study-related drugs and procedures provided at no cost

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The opportunity to contribute to our scientific understanding of a condition

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

There may be some risks or discomforts involved in taking part in a clinical study, for example:

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There are no guarantees that a participant’s health will improve

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The investigational drug may cause side effects

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Some of the procedures may carry their own risks or be uncomfortable

Participant safety is the top priority of every clinical study. Governments have strict rules to protect the safety and privacy of study participants.

What happens if I decide to take part in a clinical study?

  • First, you will be asked to read and sign an informed consent form (ICF) to show that you understand the study and that you agree to being involved. The ICF describes what will happen and when.
  • Once this is signed, the study team will carry out some assessments to see if you are eligible.
  • If you are eligible, you will be asked to come to a clinic for some health checks. Every study is different, so the number of visits and time between them will differ depending on the study.

Do I have to join?

Taking part in a clinical study is a personal decision and no one has to join if they don’t want to. You may also leave a study at any time without any impact on your usual healthcare.