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Presentation: Introduction to changes to the TGA's Clinical Trial Notification (CTN) process

TGA presentations given at the 2015 ARCS Scientific Congress, 5-7 May 2015

8 May 2015

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Presentation

  • Presented by: Ms Adelina Tan, Director, Scientific Evaluation and Special Product Access Branch, Market Authorisation Division
  • Presented at: 2015 ARCS Scientific Congress, 5 May 2015
  • Presentation summary: This presentation is an overview of the upcoming transition from a paper based Clinical Trial Notification (CTN) process to an online process through the TGA's online portal: eBusiness Services (eBS).

Transcript

Introduction to changes to the TGA's Clinical Trial Notification (CTN) process

Adelina Tan
Director, Experimental Products
Scientific Evaluation and Special Product Access Branch

Market Authorisation Division

TGA ARCS Scientific Congress 2015 5 May 2015

Slide 1 - Introduction overview

  • Background
  • Benefits
  • What preparation is required by clinical trial sponsors?

Slide 2 - Background

  • The current CTN process is paper based and quite burdensome administratively
  • Responding to sponsors request for an electronic lodgement system - improved efficiency
  • Errors in data reporting

Inaccuracies in clinical trial statistics for the reporting period 2009-2012 Introduction to changes to the TGA's Clinical Trial Notification (CTN) process

Slide 3 - Benefits

  • Improved external and internal tracking of documents (no lost signed originals)
  • Reduction in need to follow up information that may not be legible (typed over hand written)
  • Sponsor instantly knows that the CTN has been received by the TGA (no need to contact the TGA to confirm receipt) Introduction to changes to the TGA’s Clinical Trial Notification (CTN) process

Slide 4 - Benefits

  • The status of the CTN is known to the sponsor e.g. under review
  • Variations to the original application are streamlined by using the original data set
  • Reports will be more detailed and with a higher degree of accuracy

Slide 5 - Benefits

  • All clinical trial documentation relevant to the CTN will be accessible on TGA Business Services (TBS)
  • There will be no need for Sponsor, Principal Investigator (PI), Human Research Ethics Committee (HREC) or Approving Authority (AA) certification on the form
  • A guide on how to complete the CTN form will be available on TBS and the form will contain tool tips

Slide 6 - Benefits

  • More accurate, timely and detailed reports, if organisations request information from the TGA
  • Clinical trial activities and trends can be identified - could improve Australia as a better choice for the conduct of clinical trials
  • TGA time currently spent on administrative activities can be value added to review of CTN submissions space
  • Closing the loop - much easier for sponsors to inform the TGA when a clinical trial is complete

Slide 7 - What preparation is required by clinical trial sponsors?

Screenshot showing how to navigate to the TGA Business Services area on the TGA website

Slide 8 - TGA Business Services

Screenshot of the TGA Business Services web page on TGA website

Slide 9 - What preparation is required by clinical trial sponsors?

  • Apply for your client identification number - about 3 working days
  • Apply for access to TBS - about 3 working days
  • Once the TBS Helpdesk receives your completed Organisation details form, a Administrator Account is created for the nominated person - this enables that person to control who has access to the information

Slide 10 - What preparation is required by clinical trial sponsors?

  • Administrator for the organisation will be able to set up different user accounts e.g. Drafter, Submitter, Finance
  • The users of your account can then access your secure TBS portal to:
    • submit CTN forms
    • pay invoices online

Slide 11 - What preparation is required by clinical trial sponsors?

  • TGA webpage - TGA Business Services - how to use the site
    • Video
    • Frequently asked questions
  • TBS Helpdesk available to answer further enquiries

Slide 12 - CTN/ Clinical Trial Exemption (CTX) online submission - overview

  • Unapproved therapeutic goods
  • Clinical trials
  • Online submission form for CTN/CTX

Slide 13 - What is an unapproved therapeutic good?

  • Generally, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) to be lawfully supplied in or exported from Australia
  • Goods that do not appear on the ARTG, or ARTG goods being used outside of marketing approval are considered unapproved goods
  • Unapproved goods have not been evaluated by the TGA for quality, safety or efficacy

Slide 14 - Avenues to supply unapproved therapeutic goods

Flow diagram of avenues to supply unapproved therapeutic goods

Slide 15 - TGA's role in clinical trials differs from some other regulators

  • Main focus is on access to unapproved medicines and devices for trials rather than end-to-end regulation of trials
  • CTX/CTN schemes required for any product not entered on the ARTG or use of a product in a clinical trial beyond the conditions of its marketing approval

Slide 16 - CTN vs CTX Schemes - overview

CTN

  • Notification process
  • One step process
  • Medicines, devices or biologicals
  • No TGA review of data prior to trial
  • Trial cannot commence without valid notification and fee paid
  • Assurances pertaining to the trial conduct and protocol are provided by the sponsor, HREC, PI and AA
  • Each additional trial site notified before commencing trial at that site

CTX

  • Approval process
  • Two step process - part 1 (approval) part 2 (notification)
  • Medicines, devices or biologicals but required for certain class 4 biologicals
  • TGA evaluates the proposed Usage Guidelines
  • Trial cannot commence without Part 1 being approved
  • Assurances pertaining to the trial conduct and protocol are provided by the sponsor, HREC, PI and AA
  • May conduct any number of clinical trials, provided use of the product falls within the original approved Usage Guidelines
  • Each trial must be notified to the TGA

Slide 17 - Legal responsibilities

  • All trials must have an Australian sponsor who initiates, organises and supports a clinical study and carries the medico-legal responsibility

Slide 18 - Guidelines for Clinical Trials

  • Conduct of the proposed trial should be in accordance with:
    • National Health Medical Research Council (NHMRC) National Statement on Ethical Conduct in Research Involving Humans (2007)
    • Declaration of Helsinki
    • Note for Guidance on GCP or the ISO 14155 Clinical Investigation of Medical Devices
    • relevant Commonwealth and/or State/Territory laws

Slide 19 - Guidelines for manufacturing

  • Generally, a facility manufacturing therapeutic goods, including Investigational Medicinal Products (IMP) and placebo, for supply in Australia must comply with appropriate GMP standards and must be licensed accordingly
  • The TGA has adopted the PIC/S Guide for Good Manufacturing Practice for Medicinal Products 2009, with Annex 13 of this guide referring to the manufacture of IMP

Slide 20 - Clinical trial statistics

2014 total new trials - 967

Total notifications (number of sites) - 3762

New trial notifications that include a therapeutic good received by phase
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Phase 1 85 65 132 68 83
Phase 2 128 86 102 130 124
Phase 3 155 131 70 153 198
Phase 4 34 28 32 32 34
Bioavailability/equivalence 5 4 5 2 3
None specified 9 12 14 64* 76*
Total 416 326 355 449* 518*

*this number now combines those CTNs which involve device(s)

Slide 21 - Online submission of CTN / CTX

  • Currently paper driven, manually entered into a database
  • New form completed and submitted online

Slide 22 - Screenshot

Screenshot of the TGA Business Services log in page

Slide 23 - Screenshot

Screenshot of the Submissions page highlighting Create Applications & Submissions

Slide 24 - Screenshot

Screenshot of the Clinical Trial Notification page highlighting Contact Email and validation prompt

Slide 25 - Screenshot

Screenshot of the Contact Email & Confirm Email do not match prompt

Slide 26 - Screenshot

Screenshot of the Clinical Trial Notification page highlighting This Trial information

Slide 27 - Screenshot

Screenshot of the Clinical Trial Notification page highlighting This Trial, Biologicals / Devices / Medicine Details and Placebo Details sections

Slide 28 - Screenshot

Screenshot of the Medicine Details section highlighting Trade/Product/Code name

Slide 29 - Screenshot

Screenshot of the Placebo Details section highlighting Product Name

Why placebos should be entered on the CTN

Under the Therapeutic Goods Act 1989, therapeutic goods means goods:

  1. that are represented in any way to be...
    1. for therapeutic use; or...

Slide 30 - Screenshot

Screenshot of the Site Details section highlighting Site

Slide 31 - Screenshot

Screenshot of the Clinical Trial Notification page highlighting Validate

Slide 32 - Screenshot

Screenshot of the Submissions page highlighting Create Applications & Submissions and Clinical Trials

Slide 33 - Screenshot

Screenshot of the Clinical Trials Submissions page

Slide 34 - Screenshot

Screenshot of the Clinical Trials Submissions Declaration page

Slide 35 - Screenshot

Screenshot of the Submissions page highlighting Under Review

Slide 36 - Screenshot

Screenshot of the Submissions page highlighting Invoice

Slide 37 - Screenshot

Screenshot of the View invoices page

Slide 38 - Screenshot

Screenshot of the Make a payment page

Slide 39 - Screenshot

Screenshot of the Clinical Trial Notification page highlighting Change to Trial Details

Slide 40 - Questions?

Enquiries: clinical.trials@tga.gov.au

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