Researchers and Clinicians

Do you want to conduct a clinical trial?

At Calvary Mater Newcastle we have a large number of clinical trials running across six clinical trial units including Haematology, Medical Oncology, Radiation Oncology, Clinical Toxicology, Consultation Liaison Psychiatry and Palliative Care.

Researchers initiating clinical trials at Calvary Mater Newcastle must attend to trial design, resource issues, finance and budgets, ethics review, regulatory oversight, policies and research governance. Information on ethics processes, principles of research conduct, regulatory considerations and research governance can be found here.

  • What is the exact research question this clinical trial is intended to answer?
  • What is the primary outcome variable? Is this readily measured?
  • Is it a direct measure or outcome or do you intend to rely on surrogate endpoints?
  • Are these outcomes those specified by guidance documents as the preferred measures for the outcome of interest?
  • Is the trial design appropriate?
  • Are subject numbers or event numbers sufficient to give adequate statistical power to detect a difference in treatments should one exist, or demonstrate non-inferiority?
  • Have you considered the ongoing treatment of trial subjects should they respond to the unapproved medical product under investigation?
  • Is Calvary Mater Newcastle likely to be able to provide an adequate number of participants for the trial?
  • Should the trial be extended to additional sites to ensure recruitment?
  • Do you have adequate resourcing, facilities and oversight of the protocol?
  • Are adequate indemnity provisions in place for the trial, including for the staff involved?
  • Do participant informed consent documents contain a full description of the requirements, risk and benefits of trial participation, in plain English, such that participants can make an informed decision?
  • Are the investigational products correctly labelled and packaged according to the Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-Operation Scheme?

NHMRC has developed learning modules on the Australian clinical trials environment, ethical issues related to clinical trials and governance relevant to clinical trials. Whether you are a researcher, in a research office or just wanting to find out more about how clinical trials are conducted, these modules use interactive learning, interviews with experts and knowledge reviews to provide an overview of the nature and importance of the clinical trials environment and approval process in Australia.

To improve clinical trial start-up times, NHMRC have developed the Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance (the Good Practice Process). The Good Practice Process aims to streamline the site assessment and site authorisation of clinical trials by:

  • Outlining a set of principles and critical success factors for site assessment and site authorisation
  • Detailing a set of planning and preparation activities that can make a site more responsive to commencing clinical trials
  • Proposing a streamlined workflow for site assessment and authorisation
  • Adopting the Good Practice Process and employing a Clinical Trial Liaison Officer can reduce the clinical trial start-up timeframe by more than 100 days

To download a copy click here.

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