What is a clinical trial?

A clinical trial is a scientific study that determines if and how a drug or therapy works for people. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug, such as:

  • Is it effective?
  • Is it more effective than another established treatment?
  • Is it safe and/or what are the side effects?

The development of a new medicine can take more than 10 years. Although long, this length of time is vital to ensure each medicine is tested rigorously.

You may have heard of clinical trials and the “phases” associated with them.

There are 4 phases, which are defined by the FDA (U.S. Food and Drug Administration). Three phases are most commonly known.

Our knowledge about a medicine and its safety and effectiveness grows with each phase of the clinical trials.

PHASE ONE

Setting up the hive and start finding flowers

Researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

  • TIMELINE
    Months

PHASE TWO

Finding more flowers to pollinate

The study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

  • TIMELINE
    Up to two years

PHASE THREE

Preparing for large scale pollination

The study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

  • TIMELINE
    Up to two years

PHASE FOUR

Expanding to other places with different flowers to pollinate

In Phase 4 trials, studies evaluate post-market information gathered during a duration or period of usage. This helps to provide accurate drug effects, benefits and optimal use.

  • TIMELINE
    Up to two years

Finally

The essence of the trial

All the research is collected together from the trial and analysed helping health companies get closer to a cure. This will also help patients in the future by bringing treatments and drugs to the wider world quicker.