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Submissions received: Good Clinical Practice Inspections Program
The TGA would like to thank respondents who provided submissions in response to the February 2019 public consultation paper, Good Clinical Practice (GCP) Inspections Program.
Consultations closed 22 February 2019 and a total of 43 submissions were received, which comprised:
- 10 submissions from the medical technology, biotechnology or pharmaceuticals sector
- 6 submissions from Local District Health Services/Networks/Public Health Organisations
- 6 submissions from federal or state government stakeholders
- 4 submissions from medical research institutes/not for profit entities
- 4 submissions from Universities
- 4 submissions from industry associations or peak bodies
- 3 submissions from dedicated early phase units
- 3 submissions from contract research organisations
- 2 submissions from individuals
- 1 submission from a private healthcare group
All submissions that gave permission to be published on the TGA website are now available below in PDF format. A number of submissions were received with permission to publish the name and work title of the author but not the submission itself and those details are also provided below.
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
- Consultation submission: AAMRI (pdf,80kb)
- Consultation submission: AbbVie Pty Ltd (pdf,384kb)
- Consultation submission: Agenus Inc (pdf,107kb)
- Consultation submission: Alfred Health, Monash University SPHPM & Baker Heart and Diabetes Institute (pdf,212kb)
- Consultation submission: ARCS (pdf,250kb)
- Consultation submission: AusBiotech (pdf,289kb)
- Consultation submission: Australian Red Cross Blood Service, Cathleen Maguire (Hancock), Regulatory Affairs Officer
- Consultation submission: Boehringer-Ingelheim, Candice Fitzgerald, Head of Clinical Operations
- Consultation submission: Celgene Corporation (pdf,395kb)
- Consultation submission: CMAX Clinical Research, Jane Kelly, Chief Executive Officer
- Consultation Submission: CSIRO (pdf,94kb)
- Consultation submission: Dr Tania Crough, Metro North Hospital and Health Service Research Monitoring Officer
- Consultation submission: Edwards Lifesciences Pty Ltd, Christy Thiel, Director Clinical Affairs APAC
- Consultation submission: GenesisCare (pdf,99kb)
- Consultation submission: GlaxoSmithKline Australia Pty Ltd, Carrie Bloomfield, Assoc Director Clinical Research
- Consultation submission: Janssen-Cilag Pty Ltd, Anna Lam, Head Global Clinical Operations Janseen ANZ
- Consultation submission: Linear Clinical Research, Fabien Knab, Quality Assurance Manager
- Consultation submission: Medicines Australia (pdf,162kb)
- Consultation submission: Metro North Hospital and Health Service, Scott Bell, Executive Director Research
- Consultation submission: Pharmaceutical Solutions Australia Pty Ltd, Jorrit Sipkema, QA Manager
- Consultation submission: Praxis (pdf,187kb)
- Consultation submission: Royal Melbourne Hospital, Royal Women's Hospital and Peter MacCallum Cancer Centre (pdf,614kb)
- Consultation submission: Roche Products Pty Ltd (pdf,353kb)
- Consultation submission: South Western Sydney Local Health District, Kelsey Dobell-Brown, SWLHD Clinical Trial Manager
- Consultation submission: Swinburne University (pdf,71kb)
- Consultation submission: Sydney Children’s Hospitals Network, Dr Lucia Smith, Research Governance Manager
- Consultation submission: WA Department of Health, Dr Darren Gibson, Director Research
- Consultation submission: Prof Tom Walley (pdf,76kb)
A range of stakeholders from the clinical trials sector, from industry and their representative bodies, public health organisations and health districts/networks, universities and medical research institutes, private clinical groups, government stakeholders to individuals, provided submissions.
What are your thoughts on a pilot GCP inspections program and proposed establishment of a routine program following the pilot?
Submissions received in response to the consultation showed that a majority (33 of 37 that commented on this issue) of stakeholders support the introduction of a pilot program of GCP inspections, and proposed establishment of a subsequent routine inspections program, although with a common request for more information regarding:
- the inspection process (duration, selection, scope)
- categorisation/grading of findings
- mechanisms for managing responses to findings (including release to HREC / Authorising Institution), and involvement of the trial sponsor
- International collaboration (to avoid duplication), and
- Inspection fees.
A small number (n = 6) of submissions commented on the rationale for a GCP Inspections Program; particularly, that the primary objective should be protecting the rights, safety, and well-being of trial participants and data credibility rather than targeted at Australia's competitiveness as a place to conduct clinical trials. The TGA agrees that the primary objective is safeguarding public health however there may be additional benefits. Guidance documents produced in support of the pilot and/or ongoing GCP Inspections Program will better articulate the rationale for a GCP Inspections Program.
Would you consider volunteering to be a clinical trial site inspected under the pilot program?
Thirteen (n = 13) submissions included a response volunteering, subject to further information, for the pilot inspections program. Those organisations have been contacted directly to provide further information regarding the identification of trials and sites for the pilot GCP inspections program. Several responses included comments regarding the involvement of the study sponsor in the pilot GCP inspections program. It is noted that although the pilot program will involve inspections of investigator sites, the clinical trial sponsor should be notified by the institution (for example, as set out in clause 4.12 of the Medicines Australia standard clinical trial research agreement), and as a matter of courtesy.
Release of inspection findings to the approving HREC and/or Authorising Institutions.
The majority (82%) of submission which commented on this issue supported the release of findings, again with a request for further information relating to the grading of findings and closeout process, to the approving HREC and the authorising institution. Several submissions cautioned against overburdening the HREC with non-critical findings, and this will be further clarified in guidance documents.
What impact, if any, of a domestic GCP inspections program?
Comments in general that the program will have a positive effect, albeit with some risk of negative impact in the short term, depending on the findings, and some concern regarding the issue of costs.
- "The adoption of a domestic GCP inspection program could only have a positive impact on Australia's global position in the clinical trials environment."
- "The proposal … may lead to improved standards and efficiencies within the Australian clinical trials landscape if it is implemented effectively."
- "Implementation of a routine GCP inspection program would be an asset to Australia's clinical trials environment…has the potential to further strengthen Australia's clinical trials environment and international competitiveness."
- "GCP inspections held by our Health Regulator (sic), are long overdue."
- "A routine GCP inspections program is a good initiative and essential to the quality and integrity of clinical trials conducted in Australia."
- "careful consideration needs to be given to what additional cost might be incurred."
- "The pilot program will be instrumental in allowing the TGA to assess the scope, skills, resources, logistics and feedback pathway required to operate an (ongoing) inspection program in Australia."
- It is X's position that no gap (in the current regulatory oversight of the conduct of Australian clinical trials) is articulated. Australia already has a strong regulatory and ethical/governance framework for clinical trials." "What is the TGA's role in identifying and managing risk under the CTN scheme?"