Glossary & key terms

The accumulation of trial participants registered on a cancer clinical trial.

This means that a trial has met all the requirements of the trial development phase (as determined by TROG Cancer Research), has been allocated a TROG Cancer Research number and given permission to begin the process of submission for ethics review and approval to commence accruing patients.

The phase that commences when a new proposal receives the endorsement of TROG Cancer Research (based on scientific merit); successfully completes a feasibility assessment; and is approved by the TROG Cancer Research Scientific Committee as appropriate for further development.

Any of the treatment groups in a randomised trial. Most randomised trials have two or more arms.

A publicly accessible online listing (register) of clinical trials being undertaken in Australia and New Zealand. Available at http://www.anzctr.org.au/about.aspx

A randomised trial is blind if the trial participant is not told which arm of the trial they are on and is therefore unaware of whether they are in the experimental or control arm of the trial; also called masked.

A cancer research trial, or clinical trial, is a study of recruited patients to determine whether a new or existing cancer treatment is safe and effective or can be improved. 

A trial is considered closed (to accrual) after the last participant has been recruited and trial participants are in the follow-up phase.

A trial is considered completed when trial participants are no longer being examined or treated (i.e. no longer in follow-up); the database has been ‘locked’ and records have been archived.

The standard by which experimental observations are evaluated. In many clinical trials, one group of trial participants will be given an experimental drug or treatment, while the control group is given a standard treatment for the illness.

The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed.

Means a patient selected in accordance with, and who meets, the eligibility criteria specified for the trial.

The clinical and demographic characteristics that define those participants eligible to be enrolled in the trial.

Approval given by a Human Research Ethics Committee (HREC) for a clinical trial to be conducted with patients.

A process of periodic contact with participants enrolled in a trial for the purpose of monitoring health status, administering trial treatments, modifying the course trial treatment, observing the effects of the trial treatment, or for data collection.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial participants are protected.

 The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on factors including age, gender, the type and stage of a disease, previous treatment history and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate trial participants and keep them safe.

A process by which a patient voluntarily confirms their willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the patient’s decision to participate. Informed consent is documented by means of a written informed consent form (which has the name of the trial clearly displayed). It must be signed and dated by the trial participant (or the trial participant’s legally acceptable representative) and the Investigator, in the presence of each other.

A clinical trial which is supported by two or more collaborating clinical trials groups according to a single protocol. An intergroup trial requires a Trial Coordinating Centre which will support the administrative requirements of the research and perform central data collection and analysis.

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, good clinical practice, and the applicable regulatory requirement(s).

A new trial either at concept stage or with a fully developed protocol submitted for consideration and approval of TROG Cancer Research, and to be carried out under the auspices of TROG Cancer Research.

The general questions the trial was designed to answer. May be associated with one or more hypotheses that, when tested, will help answer the question.

A trial is considered open after the first trial participant has been registered.

An outcome variable of interest (also called an end point). The primary outcome is of greatest importance. Data on secondary outcomes are used to evaluate additional effects of the intervention.

A detailed written description of all aspects of the trial and accompanying consent form.

A person who is receiving medical attention, care, or treatment.