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Clinical Trial Ethics & Governance

Key dates

  • 19-OCT

    Biannual round table

  • 12-NOV

    HREC Chairs and Executive Officers annual meeting

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NSW Early Phase Clinical Trials Framework

NSW Health has developed a framework to support early phase clinical trials across NSW. Following broad support from the sector and endorsement by local health district and specialty network Chief Executives, the Framework has been approved by the Chief Health Officer.

More than 100 experts across the sector were involved in consultations to inform the design of the Framework.

The framework contains the design of two practical schemes to make NSW a centre of excellence in clinical trials, through the provision of a high quality and efficient environment to conduct early phase trials, with the ultimate aim of improving health outcomes for NSW residents.

More information on the Framework is available on the NSW Early Phase Clinical Trials Framework page.

Safety monitoring and reporting for clinical trials

In 2016, the National Health and Medical Research Council overhauled their safety reporting advice, and produced the document, Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods, which replaced the Australian Health Ethics Committee’s 2009 Position Statement, Monitoring and reporting of safety for clinical trials involving therapeutic products.

This new Guidance has been endorsed by the Therapeutic Goods Administration and restructures safety reporting responsibilities of key stakeholders. It also amends reporting pathways that previously placed an unnecessary burden on Australian investigators and Human Research Ethics Committees (HRECs) while not genuinely contributing to patient safety.

In response, NSW Health has issued a new Policy Directive (PD2017_039) titled Safety Monitoring and Reporting for Clinical Trials Conducted in NSW public health organisations (released on 27 October 2017).

Information of clinical trial safety reporting and monitoring including definitions, FAQs and forms can be found on the Clinical Trials Safety and Monitoring page.

Clinical trial roles and responsibilities

The Australia-wide Clinical Trials Jurisdictional Working Group has developed five documents to help clarify roles and responsibilities for organisations, institutions, investigators and sponsors who are engaged in clinical trials. While these documents focus on responsibilities relevant to clinical trials and should be reviewed within that context, there are some that may have wider application.

The documents are designed to help organisations develop appropriate competencies, position descriptions and training/induction programmes, develop ethics and governance policies, clarify investigators’ responsibilities, and facilitate the allocation and delegation of responsibilities for both externally (commercial/non-commercial) and internally (eg. investigator-initiated) sponsored trials.

The documents inform the Jurisdictional Working Group’s Key Priority Area of “Enhancing National Consistency for Ethics and Governance”. This aims to streamline and standardise clinical trial start-up processes to maximise efficiency and predictability. They will be used locally by NSW Health’s Office for Health and Medical Research, and nationally by the National Mutual Acceptance Scheme in order to guide policy in this area.

The following guidelines outline role and responsibilities of the Australia-wide Clinical Trials Jurisdictional Working Group.

Clinical Trial Research Agreements

Each externally-sponsored clinical trial conducted at a NSW public health organisation, whether that be by a commercial entity or a not-for-profit organisation (such as a collaborative research group), must be governed by a clinical trial research agreement. The agreement is reviewed by the public health organisation during the site specific assessment process.

NSW Ministry of Health, in collaboration with key stakeholder organisations, has developed a set of standard clinical trial research agreements:

  • Standard Medicines Australia Clinical Trial Research Agreement for Commercially Sponsored Trials (Commercially Sponsored CTRA)
  • Standard Medicines Australia Clinical Trial Research Agreement for Contract Research Organisations acting as the Local Sponsor (CRO Sponsored CTRA)
  • Standard Collaborative or Cooperative Research Groups Clinical Trial Research Agreement (CRG Sponsored CTRA)
  • Phase IV Clinical Trial Clinical Trial Research Agreement for Medicines.

The current versions of the four Medicines Australia clinical trial research agreements approved for use by NSW Health can be accessed from Medicines Australia .

NSW Health, in collaboration with key stakeholder organisations, has also developed a Clinical Investigation Research Agreement (CIRA) for use when a medical device company sponsors a clinical trial. In keeping with the terminology used in the industry, the research is known as a ‘clinical investigation’ rather than a ‘clinical trial’.

The current version of The Standard MTAA Clinical Investigation Research Agreement can be accessed from the Medical Technology Association of Australia .

Southern and eastern border states review process

Joint review of sponsor specific clauses

At regular intervals, NSW Health, together with Queensland Health, South Australia Health and the Victorian Department of Health, conducts a joint review of sponsor specific clauses for inclusion in the nominated Schedule of Clinical Trial Research Agreements (CTRAs). The panel is known as the Southern and Eastern Border States Review Panel (SEBS).

The Panel meets monthly to consider variation requests. Closing dates for submissions and Southern and Eastern Border States Review Panel meeting dates are published on the Medicines Australia website.

Purpose

The purpose of the joint review is to standardise, streamline and circumvent unnecessary duplication in the review of sponsor specific clauses for use in Clinical Trial Research Agreements approved by the New South Wales, Queensland, South Australian and Victorian government health agencies.

Scope

Although review by the Southern and Eastern Border States Review Panel is not required for Clinical Trial Research Agreements Schedule 4/Schedule 7 Special Conditions negotiations, the service is recommended to assist clinical trial sponsors with timely, standardised review.

This process only applies to the review of new clauses, and to amendments to existing preapproved sponsor specific clauses, in participating states, for use in approved standard Clinical Trial Research Agreements.

Following changes to the Medicines Australia Clinical Trial Research Agreement template versions, sponsors do not have to submit previously approved clauses for re-approval. If any minor issues (eg. clause numbering) are affected through these changes, they can be accepted directly by individual institutions.

The process covers review of clauses for on-going use by the sponsor for clinical trials conducted in participating states, and for one-off multi-site studies that involve at least one of the participating states.

The Southern and Eastern Border States Review Panel will not accept review of sponsor specific clauses for one-off single site studies. In these instances, clauses are to be negotiated directly with the relevant site.

Review process

  1. Sponsor prepares a submission for review using the standard pro forma template on the Medicines Australia website. Where appropriate, the proposed clause must reference the relevant standard CTRA clause that it will replace or amend. A justification must be provided for the inclusion of each of the proposed clauses. If possible, please highlight the change to the original clause.
  2. There is no application fee for submission to The Southern and Eastern Border States Review Panel. The sponsor submits the completed pro forma to the Southern and Eastern Border States Review Panel contact point listed on the Medicines Australia website.
  3. The participating states will jointly review the submitted clauses. The timeline for review will be dependent on the number and complexity of the clauses submitted. If the Panel assesses that the proposed amendments require external legal review, the sponsor will be provided with an estimate of timeline and cost before the external legal review starts. During the review, if necessary, the states’ legal representative will communicate directly with the sponsor’s legal representative.
  4. The participating states will notify the sponsor of approved clauses with a version number and date, and which of the standard Clinical Trial Research Agreements they are approved for. Where amendments to pre-approved clauses are approved, the sponsor will be notified that the previously approved clauses are superseded and replaced by the new approved clauses, but that existing contracts using the superseded clauses are valid until the end of that contract.
  5. The approved clauses will be distributed to all jurisdictions, including all NSW Health Research Governance Officers at regular intervals.

Medicines Australia Forms of Indemnity

Medicines Australia, in consultation with NSW Health and other key stakeholders, has developed two standard forms of indemnity in relation to commercially-sponsored clinical trials.

Where the trial is to be conducted at a site under the control of a public health organisation, whether or not the reviewing Human Research Ethics Committee (HREC) is under the auspices of that organisation, the commercial sponsor must provide an indemnity in the form of Medicines Australia’s Form of Indemnity – Standard, in favour of the public health organisation.

Where a lead Human Research Ethics Committee is reviewing a trial and the trial is not being conducted at a site where the lead Human Research Ethics Committee resides, the commercial sponsor must provide an indemnity in the form of Medicines Australia Form of Indemnity for Clinical Trials: Human Research Ethics Committee Review Only in favour of the public health organisation at which the lead Human Research Ethics Committee resides.

It is perfectly acceptable for lead Human Research Ethics Committees to choose to request a Medicines Australia Form of Indemnity for Clinical Trials: Human Research Ethics Committee Review Only up front from a Sponsor in each and every case when they review a multi-centre clinical trial whether their host institution is a site in the trial or not. This is primarily for reasons of procedural convenience; in the event that, if their institution (as a trial site) falls through, the site Research Governance Officer (RGO) will not require a Standard Form of Indemnity, and then the Human Research Ethics Committee will not then need to pursue a sponsor for an outstanding Human Research Ethics Committee Review Only indemnity. However, if the institution does become a trial site, the Research Governance Office will need to obtain a Standard Form of Indemnity in addition to the Human Research Ethics Committee Review Only Indemnity obtained by the Committee.

Both forms of indemnity must be provided by an Australian corporate entity, who is the sponsor of the clinical trial. This may be:

  • an Australian company
  • an Australian company that is subsidiary of an overseas parent company
  • an Australian contract research organisation (CRO) that has been engaged by an overseas or Australian company to conduct the trial in Australia.

It is not acceptable for an indemnity to be provided by any company as an agent of an overseas entity; that is, the commercial sponsor must provide the indemnity in its own right.

Under the Medicines Australia indemnities, the commercial sponsor agrees to compensate injured subjects on a no-fault basis in accordance with Medicines Australia Guidelines for Compensation for Injury Resulting in Participation in a Company-Sponsored Clinical Trial. The entitlement of an injured participant to claim compensation from a sponsor pursuant to the Guidelines does not displace a participant’s right of action against a sponsor at common law.

Medicines Australia Standard Indemnity Forms and Guidelines can be downloaded online.

Clinical trials insurance and indemnity requirements

NSW Health’s Clinical Trials – Insurance and Indemnity (PD2011_006) policy directive sets out the insurance and indemnity requirements for the conduct of clinical trials at sites under the control of NSW public health organisations. Compliance with this policy directive is mandatory.

The policy requires that the insurer issuing the insurance policy is either Australian Prudential Regulation Authority-approved or (if an overseas insurer) has a minimum Standard and Poor’s credit rating of A- or better. To obtain this information from the Standard and Poor’s website, register as a user and then search using the ratings tab. Alternately, you can request the insurer to confirm their rating. Insurers who are listed on the Register of Authorised Insurers approved by the Australian Prudential Regulation Authority are listed on the Authority’s website.

Currently, there is no leeway period for sponsors who do not meet the $20M coverage limit.

There are two options for sponsors who submit annual renewable certificates of currency detailing coverage for their trials that apply from year to year:

  1. sponsors can choose to either insure for the total length the clinical trial up front; or
  2. take out annual insurance.

If they choose to take out annual insurance, each year they will need to present an annual certificate of currency demonstrating their compliance with the insurance requirements set out in policy directive (PD2011_006).

Legal Services Panel

The NSW Government has established a Legal Services Panel which offers a range of legal services and expertise to meet the external legal needs of NSW Government agencies.

NSW public health organisations may engage the Panel for advice on all legal matters, which may include Clinical Trial Research Agreements (CTRAs) and research governance matters.

Contact information is available via Procure Point. Go to ‘Information for buyers’ then ‘How to buy from this scheme’ and follow the instructions to complete the Legal Services Order Form.

As always, for any clarifications on NSW Health policy, please contact the relevant NSW Health Branch contact, such as the Office for Health and Medical Research for Research Policy queries.

The Office for Health and Medical Research wishes to thank Holman Webb Lawyers and, in particular, Alison Choy Flannigan, for acting as the Preferred Legal Advisor from 2008 until August 2018. We have sincerely appreciated the assistance she and they have provided on many occasions to public health organisations and to the Office.

Updated 5 months ago