Participant

A clinical trial is a research study in human volunteers that aims to answer the following questions in a controlled environment:

1- Does the treatment work?
2- Is the treatment safe – does it have side effects?
3- Is the treatment ‘better’ that other treatments that are already available? ‘Better’ could mean:

  1. Does it have less side effects?
  2. Does it work faster?
  3. Is it cheaper to buy?

Carefully conducted clinical trials are the fastest and safest ways to find treatments that improve the health and quality of life of people with respiratory diseases.

Clinical trials are the final step in a long process that begins with research in a laboratory. Of 5,000 to 10,000 potential drugs, only 5 make it to be tested in clinical trials and of these only 1 is approved by the regulatory authorities and becomes available to patients.

CLINICAL TRIAL PHASES

  PHASE I PHASE II PHASE III PHASE IV
NUMBER OF
PARTICIPANTS
  • 10-20
    healthy volunteers
  • 100-300
  • 1,000-10,000
  • 10,000+
LENGTH OF STUDY
  • Days to weeks
  • Months to 1-2 years
  • Months to 1-2 years
  • Years
GOALS
  • Test if the drug is safe
  • Test if the drug is safe
  • Find the best dose
  • Confirm safety and efficacy
  • Compare to current treatment
  • Provide data for government approval of drugs
  • Post-marketing surveillance
  • ‘Real life’ – test long-term safety in a diverse patient population

At TrialsWest, we focus on Phase Ib, II, III and IV clinical trials.

WHAT DOES PARTICIPATION IN A CLINICAL TRIAL AT TRIALSWEST INVOLVE?

Clinical trials that we are involved in typically run for between 3 months and 2 years. All visits take place in our rooms at 6 Barrington Street, Spearwood in Perth, Western Australia. Each visit usually takes between 1 and 5 hours, but this varies from trial to trial.

The types of tests or procedures that are performed during the visits can include (but again vary from trial to trial):

  • Breathing tests (spirometry)
  • Blood tests
  • Urine tests
  • Vital sign measurements (blood pressure, pulse, temperature, oxygen saturation)
  • Physical examinations
  • ECGs
  • Questionnaires

Before you can be involved in a study you must provide your written, informed consent by signing and dating the Consent Form. This is done after taking the time to read and have explained to you the Patient Information Sheet that tells you:

  • What the purpose of the clinical trial is
  • How you/we will determine whether you are eligible to participate
  • What you will have to do if you are involved
  • What are the benefits and risks of being involved
  • What the known side effects of the treatment(s) are
  • What happens after the trial ends

Participation in a clinical trial is ALWAYS voluntary and even if you decide to participate, you can withdraw at any time and for any reason.

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