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Clinical Trials

What is a clinical trial?

  • A clinical trial is a type of research where disease treatments are tested on patients. A clinical trial can test many aspects of treatment, including the safety and effectiveness of new medications, the addition of new medications to standard treatments and potential new methods of administering standard treatments.
  • Trials usually compare a new treatment with a standard treatment whose effects are already known. These trials are called randomised controlled trials. In these trials, half the patients receive the new treatment and half receive the standard treatment. A computer determines which patient receives which treatment to ensure that the comparison is truly objective and not biased. This is the process of randomisation and hence the term randomised trial. If the doctors who treat the patients were to decide who receives the new treatment and who does not, they might be biased towards choosing the sickest patients to receive the new treatment, making the results less accurate and less reliable for the future.
  • The protocol of a clinical trial is examined and approved by ethics committees and must meet rigorous government and medical standards. A significant amount of careful, detailed research is conducted on the new medication before it reaches the stage where it is tested on patients.

 Clinical Trial Phases: Differences 

There are different types of trials in which a person may participate. They are listed in the following table:

Trial Type

Major Differences

Phase I

  • Tests for safety and appropriate dose of a new treatment (does not compare it with another treatment)
  • Increased risk of side effects
  • Usually includes only a small number of patients who often have advanced disease that has not responded to current treatments

Phase II

  • Tests for side effects and effectiveness of new treatment (does not compare it with another treatment)
  • Larger number of patients than a Phase I trial

Phase III

  • Further tests the new treatment on large numbers of patients once the Phase II trial has shown the treatment to be safe and effective
  • The new treatment is compared with a standard treatment to assess if the outcome is more beneficial for patients (randomised controlled trial)

Phase IV

  • Further study of the treatment after it has been approved for use in clinical practice

Participating in a Clinical Trial

  • Many people respond very well to lymphoma treatments. However, there are some people who do not respond as well to treatment and there are some types of lymphoma where treatment is less successful. As such, research is constantly searching to develop new treatments and to improve existing ones.
  • A major part of developing new treatments involves clinical trials' carefully planned research that is conducted on patients in order to test new medications or new treatment approaches. The new treatment is usually compared with an existing treatment to assess if the outcome is more beneficial for patients.

What are the benefits of participating in a clinical trial?

  • Experimental treatments are not available to people outside of a clinical trial. For a treatment to be given to people in Australia, it must have been rigorously studied and tested, and must be approved by the Therapeutic Goods Administration (TGA). The TGA is the government body which assesses and monitors all therapeutic goods to ensure that they are of an acceptable standard before becoming available to the Australian community. 
  • The main benefit of participating in a clinical trial is that people can receive new treatments that are not yet available for clinical practice. For example, if a person has received the standard therapy for their particular type of lymphoma and has not achieved the desired response, a clinical trial may be a good option.

What are the risks associated with participating in a clinical trial?

You should be aware of the risks before participating in a clinical trial. They include:

  • The treatment may be toxic such that you may experiences severe side effects
  • The treatment may prove less effective than standard therapies and offer little or no benefit
  • You may be in the control group of the clinical trial and as such may receive a standard lymphoma therapy and not the experimental drug.

People who choose to take part in a clinical trial must give informed consent. This means they acknowledge that they understand both the potential benefits and associated risks and that they are a willing participant. No person should be forced or pressured into participating in a clinical trial. Furthermore, once a person is in a trial they have the right to leave the trial at any time without explanation. Leaving a trial will in no way affect the attitude of your healthcare team, and you will still receive the best current standard treatments.

Video: Clinical trials in the treatment of lymphoma