Using Australian Clinical Sites – Challenges for International Sponsors
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Using Australian Clinical Sites – Challenges for
International Sponsors
Prof A J (Tony) WebberClinical Network Services Pty Ltd
Brisbane, Australia
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General Considerations
Australian Health Care System• public and private sector providers• supported by a federal Medicare system• both sectors considered to provide quality
health care• major hospitals in both sectors exhibit a
strong commitment to medical research• many are experienced clinical trial sites• access to trained study/site coordinators
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Australian Regulatory System
Two major Australian Government Bodies
• Therapeutics Goods Administration (TGA)
• The National Health and Medical Research Council (NH&MRC)
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Therapeutic Goods Administration
• TGA – acts as Australia’s regulatory authority in relation to the registration and/or listing of pharmaceuticals, neutraceuticals, and medical devices
• Has adopted ICH GCP in principal – minor amendments concerning membership of Institutional Review Boards and comments concerning informed consent, retention of records and adverse drug reporting
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National Health & Medical Research Council
• Allocates funds for health and medical research
• Provides health advice• Considers ethical issues • Regulates sensitive medical research
activities
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Other Organizations
• Office of the Gene Technology Regulator (ORTG)• An additional level of approval for genetically modified
products
• Gene and Related Therapies Research Advisory Panel (GTRAP) • GTRAP is a subcommittee of the Research Committee, a
principal committee of the NHMRC.• Provides advice to Council on scientific, medical and
technical issues related to gene and related therapies, xenotransplantation and human stem cell research;
• Medicines Australia• Represents Australian pharmaceutical manufactures• Gives guidance on issues such as the form of indemnity
governing clinical trials and patient compensation
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Approval for the Conduct of a Clinical Trial – The Sponsor
• The Sponsor of a clinical trial to be undertaken in Australia MUST be an Australian legal entity
• Contract Research Organizations holding a TGA “Enterprise Number” can perform the role of Australian Sponsor when an overseas company does not have Australian office or agent
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Regulatory Approval to Conduct a Clinical Trial – Two Routes
Clinical Trial Notification (CTN)• 95% of all trials approved by the CTN
route• Onus on Human Research Ethics
Committees (HREC) for• ethical considerations • scientific merit/safety of the study.
• TGA will provide written acknowledgement within 10 days of receiving notification via a CTN form and appropriate payment.
• A separate CTN form for each site
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Regulatory Approval to Conduct a Clinical Trial – Two Routes
Clinical Trial Exemption (CTX)• Sponsor submits an application to the
TGA for its evaluation and comment. • Review of clinical and pre clinical data is
required to be completed within 50 days.• This clock may be stopped for questions • Once approved, the study can then be
considered by HRECs and conducted at any number of sites
• If a HREC is concerned with scientific/ safety issues of a study submitted to it for CTN approval it can require that the study go through the CTX process
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Clinical Trials in Australia- CTN Applications
650 727794
11091247
1597
1908
1710
1989
22352374 2378
0
500
1000
1500
2000
2500
1992-93 1993-94 1994-95 1995-96 1996-97 1997-98 1998-99 1999-00 2000-01 2001-02 2002-03 2003-04
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Clinical Trials in Australia - CTX Applications
3337
23
9 9
3 3 4
8
5 2
0
5
10
15
20
25
30
35
40
1993-94 1994-95 1995-96 1996-97 1997-98 1998-99 1999-00 2000-01 2001-02 2002-03 2003-04
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Summary of Australian Regulatory Process
ProcessCTN
(Clinical Trial Notification)
CTX(Clinical TrialExemption)
TGA Review
Not required
HREC Approval
Agency Timelines
7-14 days 30 days or 50 days
Fees $A240($US188)
$A15,300($US11,964)
% per year
99 1
CTX similar to IND
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Ethics Approval
• Irrespective of route, CTN or CTX, all clinical trials must be submitted to an Australian Independent Ethics Committee, termed HRECs in Australia
• HRECs must comply with the requirements laid down by the NH&MRC who has a responsibility to oversee their operation
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Approval Times
• Most HRECs and their Research Committees meet monthly
• Some will not meet December/January• Submission dates range from 2-6 weeks
before scheduled meetings• Approval between 5 weeks to 8 weeks
from submission to approval• Typically, overall process takes 8 13
weeks
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Informed Consent Forms (ICF)
• Must conform with the particular HREC’s requirements (template) and ICH GCP
• Likely to require major changes from the sample ICF often provided by overseas sponsors
• Australian details on data protection, patient compensation and reimbursement must be included
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Patient Recruitment Issues
• Payments• reimbursement all out of pocket
expenses associated with attending clinical trial visits – Must be approved by the HREC and detailed in the patient information sheets
• Advertising• Advertising and accelerated recruitment
strategies require HREC approval
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Indemnity and Insurance
• The majority of HRECs have standardised on, and require sponsors to use, the “Form of Indemnity for Clinical Trials” published by Medicines Australia www.medicinesaustralia.com.au
• While clinical trial insurance may be held by the overseas sponsor, some Australian states require clinical trial insurance to be held by an Australian legal entity
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Labelling Requirements
Major points• Name of the Sponsor – must be the
sponsor listed on the CTN form• Pharmaceutical dosage form,
administration route etc• Batch and/or code number• Trial subject identification – where
appropriate• Directions for use• “for clinical trial use only”
www.tga.gov.au/docs/pdf/unapproved/unapp.pdf
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Study Close-out and Archiving
• Australian regulations stipulate records be retained for 15 years following completion of a clinical trial, or
• As per ICH GCP requirements, whichever is longer
• Investigational sites often request additional financial support from the sponsor for off site archiving by a third party or that the sponsor supports this process directly.
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Thank you!