Medical researchers are required to undertake clinical trials to test all new drug therapies, devices, techniques and other treatments that are intended to be used to treat humans. Volunteers, often with serious diseases, are recruited to test new therapies and determine how well they work. Proposed treatments involving genetic technologies are subject to the same, or higher, level of scrutiny in clinical trials as all other new treatments.

Government regulatory bodies oversee clinical trials and consider their results a central part of the approval process for all new treatments. Australia’s Therapeutic Goods Administration (TGA) has national responsibility for approving and monitoring all new medical treatments. Its powers and procedures are consistent with its counterparts in other countries, including the US Food and Drug Administration which provides the international benchmark in this field.

Clinical Trials

Clinical trials involving human subjects are generally undertaken after a treatment has been developed and tested using animal trials.

Up to four phases of clinical trials can be undertaken:

  • Phase 1: the proposed treatment is administered to a small number of human subjects to ensure it’s safe, identify side effects, and determine safe dosage levels.
  • Phase 2: the treatment is given to a larger number of subjects, usually several hundred, who suffer from the targeted illness, to test its effectiveness and further evaluate its safety.
  • Phase 3: up to several thousand sufferers of the illness are given the treatment to confirm its effectiveness, monitor side effects, compare it to existing treatments, and refine safety controls.
  • Phase 4: patients who receive the treatment after its approval and release are monitored to provide ongoing data on effectiveness, optimal treatment regimes, and safety.

The National Health and Medical Research Council (NHMRC) has set strict and comprehensive guidelines for clinical trials in its National Statement on Ethical Conduct in Human Research.

These include:

  • A clinical trial must be approved by a Human Research Ethics Committee (HREC) attached to the institution conducting the trial. Ethics committees are made up of professional and community representatives.
  • Clinical trials must observe Commonwealth, State and Territory laws, NHMRC guidelines, World Medical Association guidelines, the Note for Guidance on Good Clinical Practice (as set by the International Committee for Harmonisation) and meet standards set by the TGA and the International Standards Organization.
  • They must be designed to answer specific questions about a therapy or procedure that shows promise of being at least as good as existing ones.
  • Clinical trials must be conducted by qualified people who must be fair in their selection and recruitment of participants.
  • Risks to trial participants must not outweigh likely benefits.
  • Participants, or their legally responsible guardians, must be given sufficient information to ensure they can give their informed consent, and their privacy must be protected.
  • It is unethical to use placebos or other means whereby a control group of participants do not receive a treatment that has been shown to be effective, or where there is risk of significant harm in the absence of treatment. Proposed trials involving control groups may be considered by the HREC if there is genuine uncertainty about the net clinical benefit of a treatment.
  • Trials may be terminated if participants experience unexpected side effects or if it is deemed to be in the public interest.
  • If a trial is comparing treatments and one proves much better or worse than the others, the trial may be modified or terminated so that no participants are disadvantaged.
  • Data, records and biological samples should be preserved, so that participants can be traced if late or long-term effects emerge.
  • Researchers must make arrangements for adequate compensation to be provided to any participant injured in a trial.
  • HRECs must be informed of any possible conflict of interest facing researchers involved in the design and conduct of a clinical trial. The HREC must be kept up to date on the trial as it progresses, and must be told about any serious or unexpected events in the trial

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