Learn more about what happens to the information that is collected during a clinical trial.

What Happens to Information Collected During a Clinical Trial?

Information refers to both your personal and health information that is collected during a clinical trial. The information collected might include your age, gender, medical history, cancer diagnosis, the results of blood tests and scans, medications received, and side effects. The exact information collected will depend on what the clinical trial is trying to find out.

By signing a consent form for a research study, you consent (agree) to the study doctor and research staff collecting and using personal and health information about you for that research study. All personal and health information collected for the study remains confidential.

Your personal and health information will only be used for the purpose of the study and any related future research (see Data Sharing and Data Linkage), and it will only be used with your permission, except as required by law.

Information about you may be obtained from your health records held at the hospital where you are treated and other health services for the purpose of the research. By signing the consent form, you agree to the study team accessing health records if they are relevant to your taking part in the study. Information about your participation in the study may be recorded in your health records.

Once studies have been completed, hospital records will be retained in a locked storage facility for a long time (over 15 years). Only staff involved with the study will have access to the information. Data from your participation in the study and test results will be stored by Breast Cancer Trials (BCT) for at least 15 years and may be retained for an indefinite period.

Neither your results nor your samples will be identified with your name. Instead, a participant code will be used in all documentation related to the study. Your involvement in the study must be noted in your clinical records which can be seen by the doctors and clinic staff involved in your care.

If a study is being run by an international sponsor or group, your data will be sent overseas to the study-specific team. Privacy laws and rules about accessing data may not be as strong as those in Australia or New Zealand. BCT will take all reasonable steps to ensure that the overseas sponsor or group handles your data according to Australian and New Zealand privacy requirements.

  • Results

    BCT publishes the results of its clinical trials in scientific and medical journals that have been reviewed by health professionals, and present the results at conferences and other professional forums.

    No-one who took part in any clinical trial will be named and no personal identifying information will be included in any publication or presentation. It is usually a number of years before the results of a study are available. You will be contacted about the results by your study doctor.

  • Data Sharing

    Data sharing is making the information collected during a trial available to other researchers after the trial is finished. Data is usually made available after the main or final results of the study have been published. Sometimes the data from one trial may be put together with data from other trials, helping researchers to see the results of certain treatments more clearly. Data sharing can also help researchers think of new ideas for research.

    Access to the data by other researchers will only be allowed if they agree to preserve the confidentiality of the personal and health information as requested in this form. Their access will also require approval from the original research team AND approval from a Human Research Ethics Committee (HREC).

  • Data Linkage

    Data Linkage creates links between information about a person from different sources including, but not limited to, medical records, and registries like the Australian Cancer Database and the National Death Index in Australia, or the Health Statistics and Data Sets in New Zealand. These agencies are also referred to as data custodians.

    Data Linkage is done to collect additional information, for example any further diagnosis for cancer, long after a person has stopped taking part in a study. Data linkage is an effective way for researchers to continue to look at the long term effectiveness of the treatments used in a study, without needing to directly contact participants.

    By agreeing to take part in a BCT clinical trial, BCT may in future request your identifiable information such as name, date of birth and address from the hospital where you took part in a BCT trial to use for Data Linkage. By taking part in the clinical trial, you agree to provide, or allow the hospital to provide, this information if it is required.

    Your identifiable information, such as your name, gender, date of birth, address and linked registry data, will only be requested if:

    • BCT decides to proceed with Data Linkage, AND
    • Only after all required approvals for data linkage have been obtained such as:
      • Ethics review and approval from the relevant HREC(s) for a project requesting access to your information for data linkage
      • Permission from the data custodian(s) (who perform data linkage from your identifiable information).

    BCT will strictly maintain privacy and confidentiality, and will ensure that your information is stored, used and transmitted securely. BCT will only use your identifiable information to provide to the data custodian(s) for Data Linkage. Your identifiable information will never be released to researchers; instead, project-specific patient codes will be created by the data custodian(s) before giving it to researchers.

  • Inspection of Records

    Your health records and any personal and health information obtained during a clinical trial are subject to inspection (to check that all the procedures and data are complete and accurate) by the relevant authorities (such as the Therapeutic Goods Administration or Medsafe) and authorised representatives, collaborators and licensees of BCT, other organisations involved in the study (e.g. a pharmaceutical company, international collaborative group), hospitals participating in the study, or as required by law.

    By signing the Consent Form, you authorise release of, or access to, this confidential information to the relevant study personnel, regulatory authorities, and parties as noted above.

You Can Access Your Personal and Health Information

In accordance with relevant New Zealand, Australian and/or State privacy and other relevant laws, you have the right to request access to the information collected and stored by the study team about you. You also have the right to request that any information with which you disagree be corrected.

Please contact the study team member listed on the study’s Information Sheet/Consent Form if you would like to access your information.