Clinical trials are a key step in bringing new or improved medicines, interventions, or tests to market to prevent, detect, treat, or manage all types of diseases or medical conditions. 

A clinical trial involves people and aims to investigate whether a medicine is safe and effective for the treatment of a disease or medical condition. At PCRN, we conduct clinical trials on behalf of pharmaceutical and biotechnology companies which have been approved by New Zealand regulatory authorities.

There are several phases in a clinical trial process:

• Phase I Trials
  Phase I trials test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety and identify side effects.
  
  
• Phase II Trials
  After safety has been confirmed, phase II trials test the experimental drug or treatment in a larger group of people (100-300).
  
  
• Phase III Trials
  Phase III trials test the experimental drug or treatment in a large group of people (1,000-3,000) to confirm its effectiveness. Usually, two successful trials are required before a drug or treatment is approved by the U.S. Food and Drug Administration.
  
  
• Phase IV Trials
  Phase IV trials acquire additional information about an experimental drug or treatment after it has been approved

All clinical trials have guidelines about who can participate. Criteria may include age, gender, the type and stage of a disease, previous treatment history and other medical conditions.

Some trials need healthy participants to test the safety of new interventions or tests, particularly in early-stage trials. In these trials, healthy participants can be compared with patient participants. They receive the same test, procedure, or drug that the patient group receives, and researchers can compare the effects and side effects of the new test, procedure or drug between the two groups.

Many trials need participants who have the disease or condition that the new intervention targets. Patient participants test the new intervention to see what effect it has on their disease or condition.

If you participate in a clinical trial, you can access new research treatments before they are widely available, and your participation may also help others by contributing to medical research.

In addition, you may:

• Learn more about your health condition
• Potentially gain access to new medications at no cost
• Receive free regular health and wellbeing check-ups
• Assist with improving the health of future generations

Before agreeing to participate, our Clinical Research staff will clearly explain the risks and potential benefits involved. Once your eligibility to participate has been confirmed, you will be provided with an informed consent document containing information about the trial and what it will involve.

This informed consent document will need to be signed by the participant (or legal guardian) before taking part in the trial.

The information you will be given as part of the informed consent includes:

• Purpose of research
• Foreseeable risks
• Potential benefits
• Disclosure of alternative procedures
• Confidentiality
• Course of action if more than minimal risk involved
• Who to contact
• Participation is voluntary

We recommend learning as much about the trial as possible before signing the informed consent document. Here are some helpful questions to ask:

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the experimental treatment being tested may be effective?
• Has it been tested before?
• What kinds of tests and experimental treatments are involved?
• How do the possible risks, side effects and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the experimental treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow-up care is part of this study?
• How will I know that the experimental treatment is working?
• Will the results of the trials be provided to me?
• Who will be in charge of my care?

Depending on the trial, researchers conducting clinical trials can be part of hospitals and other medical institutions, specialised research groups, universities, or pharmaceutical, medical device and biotechnology companies, or a combination of these.

At PCRN our clinical trial team includes doctors and nurses and may also involve other health care professionals, social workers, biostatisticians and trial coordinators and monitors. At the beginning of the trial, the clinical team will take initial measurements and a medical history from the participant and give them clear information about what to expect in the trial and what they need to do.

During the trial, each participant is monitored carefully by members of the trial team.

Clinical trials can be sponsored by organisations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies.

This is very dependent on the nature of the clinical trial with some trials lasting just a few days while others can take several years.  Participants are generally asked to come into one of our clinics for regular visits. A number of our trials may require more doctor visits than would be normal for an illness or condition.

A description of what’s expected of the participant should be made available before signing the informed consent document.

At the beginning of a clinical trial, a team of doctors, nurses and other health professionals checks the health of the participant and gives specific instructions for using the treatment, medication, or device throughout the trial. The team monitors the participant as the trial progresses and stays in touch after the trial is completed.

In New Zealand, all clinical trials must be approved by the New Zealand Health and Disability Ethics Committee. This process involves evaluating whether the potential benefits of study participation outweigh the risks. 

For the most part, clinical trials are safe. However, there is always some risk associated with any medicine and because there is no way to predict how an individual will respond to a new medicine, there will be additional risks. We will always advise the participant of these risks and they will be closely monitored throughout the trial to check the new medicine or treatment is well tolerated.

If you would like advice as to your rights as a participant in a clinical trial you may approach a Health & Disability Consumer Advocate by contacting:

• Free Phone: 0800 555 050
• Free Fax: 0800 2 SUPPORT / 0800 2787 7678
• Email: advocacy@hdc.org.nz.
   

Clinical trials that are sponsored by manufacturers of drugs or medical devices are not covered by Accident Compensation Corporation (ACC). Therefore, compensation is provided by the company sponsoring the clinical trial which is at least as comprehensive as that available under ACC. The investigator will provide further details during the consent process.

Yes. Your privacy is of the utmost importance and we are committed to ensuring your medical information is kept strictly confidential. The data we collect gets de-identified and analysed but your personal information is closely guarded.

Participants are generally asked to come in for regular visits at an accessible clinical trial site, which may be a doctor’s office or a dedicated PCRN clinical trial centre. Some trials require more doctor visits than would be normal for an illness or condition.

Many trials involve a physical examination or medical history review after enrolment. A description of what’s expected of the participant should be made available before signing the informed consent document.

Yes. You can leave a clinical trial at any time without it affecting your future care with the primary health care provider.

The team at PCRN has over 35 years of experience in conducting world-class clinical trials across a wide range of therapeutic areas to enhance the health and wellbeing of our diverse population. In New Zealand, all clinical trials must be approved by relevant regulatory authorities before the trial can start.

There are a number of different types of clinical trials, including:

• Treatment trials test experimental treatments, new combinations of drugs or new approaches to surgery or radiation therapy.
• Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning.
• Diagnostic trials evaluate tests or procedures for diagnosing a disease or condition.
• Screening trials evaluate methods of detecting a disease or health condition.
• Quality of Life trials (or Supportive Care trials) evaluate methods of improving the comfort and quality of life of patients with chronic illness.