WHAT HAPPENS TO INFORMATION COLLECTED DURING A TRIAL?

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.

Some clinical trials may look at how your treatment affects the health care services you use. To do that, they may ask to use the personal and health information that Services Australia collects each time you use a medical service (via Medicare) or buy medicines via the Pharmaceutical Benefits Scheme (PBS). This will help the study researchers determine whether having a particular treatment or test represents value for money.

You will be asked to sign a separate consent form allowing the study researchers to access your Services Australia information; you will be given a separate Services Australia Participant Information Document, and Participant Consent Form.

Services Australia will not itself be involved in the research, other than to provide the information that you consent (agree) to them releasing to the study researchers. Services Australia will have confirmed that the particular clinical trial and any associated documents have received approval from a Human Research Ethics Committee (HREC) that is registered with and operates within guidelines set out by the National Health and Medical Research Council (NHMRC). Services Australia also has its own ethics committee that will approve the collection of your Services Australia information for the specific clinical trial.

Taking part in the collection of your Medicare and PBS information is optional. You will be able to take part in the clinical trial even if you decide not to allow the study researchers to collect this additional information.

Completing the consent form will allow the study researchers to access your complete Medicare and PBS data as outlined in the consent form. Medicare collects information on your medical visits, procedures and associated costs. The PBS collects information on the prescription medications you have filled at pharmacies.

This information will be collected only if it is available through Services Australia. Collection will occur several times throughout the study, but you will only need to complete the consent form once.

The information collected about you may include the following (but will depend on the information required by the clinical trial):

Medicare Benefits Schedule (MBS)

• Date of referral, date of service, MBS item number and description of the MBS service (for the test or procedure done by a ‘service provider’)
• Provider charge (the dollar amount the provider charged for the service)
• Schedule fee (MBS fee that is the Government’s recommended fee for that service)
• Benefit paid (this is the Medicare benefit paid to the patient).

Pharmaceutical Benefits Scheme (PBS)

• Date of supply (date the prescription was supplied by the pharmacy)
• PBS item number and PBS item description (as noted in the PBS)
• Patient contribution (the contribution paid by the patient)
• PBS net benefit (amount paid by the Government)
• Anatomical Therapeutic Classification (ATC) Code and Name (a classification scheme for drugs).

You can withdraw from providing Medicare and PBS information at any time by completing and signing the Services Australia Withdrawal of Participation Form, which will be given to you any time you ask for it.

Click here for further information about Services Australia information provided for research.

Storage, Retention and Destruction of Services Australia Information

Signed Services Australia Participant Consent Form are stored in secure locked storage in Australia at BCT that can only be accessed by approved clinical trial personnel. The consent form will be sent securely to the Australian Government Department, Services Australia, who will retain this for the life of the study as a record of participant consent.

Data provided from Services Australia will not contain any identifying information. Identifying information will be replaced with a study identification number. Services Australia information will be stored securely on computer systems located within Australian borders.

Services Australia information is not sent outside of Australian jurisdiction and is governed by the Privacy Act 1988.

All information will be securely destroyed in an appropriate manner after the final publication of the clinical trial (at least 15 years). Researchers will be notified that they have to destroy the data and must provide a signed statutory declaration to Services Australia advising when the data has been destroyed.

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 the information about the trial. Their access will also require approval from the original study researchers AND approval from a Human Research Ethics Committee (HREC).

BCT is excited to be involved in a national project, working with the Australian Research Data Commons (ARDC), and using the opportunities that the sharing of research data can hold for members and the wider research community. The ARDC, in conjunction with the health research community is building the Health Studies Australian National Data Asset (HeSANDA).

Health research studies and clinical trials create a wealth of information about the participants in the research, their health and the interventions being studied. That data generated is valuable to more than just the original study, however, issues of patient privacy and the naturally siloed approaches of some research groups and government jurisdictions means that sharing data for these valuable purposes is complex and sometimes impossible. Click here for more information.

ARDC have released a series of short videos regarding Data Sharing and the HeSANDA project. To watch the videos, click the links below:

• Benefits of Data Sharing
• What is Health Data Australia?
• Setting up a New Clinical Trial for Data Sharing
• Why is Metadata Important for Research?

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.

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.