Clinical Trials - Overview of NHMRC engagement with stakeholders

Engagement with stakeholders is integral to the development and implementation of NHMRC clinical trial reform initiatives.

Below is an overview of NHMRC’s recent engagement:

May 2017

NHMRC in conjunction with conjunction with the ACTA and other key stakeholders, celebrated International Clinical Trials Day at the Clinical Trials 2017: National Tribute and Awards Ceremony, where the Minister for Health announced 33 million in funding for Australian Clinical Trials and the 2017 ACTA Trial of the Year.

In conjunction with ARCS , broadcast a webinar on the Human Research Ethics Application
April 2017 Held a AHEC Working Group meeting
March 2017
  • Presented on HREA to Swinburne University
  • Presented on HREA to University of Tasmania
  • In conjunction with ARCS , broadcast a webinar on revised guidance on Safety Monitoring and Reporting
February 2017
  • In conjunction with ARCS , broadcast a webinar on the Good Practice Process
  • Reported to the Clinical Trials Jurisdictional Working Group and the Clinical Trials Advisory Committee 
December 2016
  • Held a meeting of the AHEC Clinical Trials Safety Monitoring and Reporting Working Group
  • Participated in a meeting of the NSW Cancer Institute to discuss cancer clinical trials operational performance
November 2016
  • Presented at the ARCS Clinical Leadership Symposium
  • Presented at the Australasian Ethics Network Conference
  • Reported to the NSW Health Medical Research Exchange meeting
  • Met with Medicines Australia
  • Participated in the MTP Connect meeting
October 2016
  • Held a AHEC Working Group meeting to finalise guidance on Safety Reporting and Monitoring in clinical trials
  • Presented at an e-Research Conference in Melbourne
  • Held HREA Advisory Group meeting
  • Presented at the Victorian Association of Research Nurses Professional Development day
  • Presented at a  Research Governance workshop in Tasmania
September 2016
  • Held Clinical Trials Ready meeting
  • Reported to the Clinical Trials Jurisdictional Working Group
  • Reported to the National Mutual Acceptance scheme Working Group
  • Presented at International Network of Research Management Societies (INORMS) conference
August 2016
  • Held separate HREC Chairs and HREC Executive Officers Meeting
  • Presented at the Royal North Shore Hospital Sponsor’s Forum
  • Presented at the University of Sydney  to HREC Chairs
  • Reported to the Clinical Trials Jurisdictional Working Group
  • Reported to the National Mutual Acceptance scheme Working Group
July 2016
  • Presented at  Society of Clinical Research Sites conference
  • Reported to the Clinical Trials Jurisdictional Working Group
June 2016 Held a teleconference of a working committee established to revise the NHMRC Position Statement: Monitoring and Reporting of Safety for Clinical Trials

May 2016

  • Participated in the Cancer Institute NSW Clinical Trials Portfolio Policy Meeting
  • Presented at the ARCS scientific congress
  • Held a Clinical Trials Portal Advisory Committee Meeting
  • Reported to the Clinical Trials Jurisdictional Working Group
  • Presented at the ACTA Clinical Trials Breakfast
  • Reported to the Victorian Hospital Research Director’s Forum
  • Worked with stakeholders to promote International Clinical Trials Day
  • Held a public consultation on the Revised Position Statement on Safety Reporting and Monitoring in Clinical Trials Involving Therapeutic Goods
  • Reported to the National Mutual Acceptance scheme Working Group
  • Presented to the Victorian HREC Chairs and Executive Officers meeting

March 2016

  • Reported to the Clinical Trials Jurisdictional Working Group
  • Reported to the Australian Health Ethics Committee
  • Reported to the Australian Innovation Advisory Committee
  • Reported to the National Mutual Acceptance scheme Working Group
February 2016
  • Participated in a CTAC Communications Working group meeting
  • Held a meeting of a working committee established to revise the NHMRC Position Statement: Monitoring and Reporting of Safety for Clinical Trials
  • Held a Human Research Ethics Application Advisory Group Meeting
January 2016 Held a meeting of a working committee established to revise the NHMRC Position Statement: Monitoring and Reporting of Safety for Clinical Trials
December 2015
  • Reported to the Clinical Trials Advisory Committee meeting
  • Reported on the progress of the HREA to the Australian Health Ethics Committee
November 2015
  • Participated in A CTAC Communications Working subgroup meeting
  • Reported to the Clinical Trials Jurisdictional Working Group
  • Held Good Practice Process Pilot interim Meetings
October 2015
  • Presented at the Australian Clinical Trials Alliance Symposium
  • Presented at the Ausbiotech National Conference
  • Presented at Townsville Hospital and Health Services Research Week
  • Published an online survey for General Practitioners on participation in clinical trials (closed 9 October 2015)
September 2015
  • Published an online survey for General Practitioners on participation in clinical trials (deadline extended to 9 October 2015)
  • Reported to the Clinical Trials Jurisdictional Working Group
  • Participated in CTAC Communications Working subgroup meetings
  • Held a Human Research Application Form Advisory Group Meeting
August 2015
  • Published an online survey for General Practitioners on participation in clinical trials (this closes on 30 September 2015)
  • Held a roundtable to develop  Core Competencies for Academic Clinical Trialists
  • Participated in CTAC Communications Working subgroup meetings
  • Held a Clinical Trials Portal Advisory Committee Meeting
  • Reported to the Clinical Trials Advisory Committee meeting
July 2015
  • Presented at the Society for Clinical Research Sites - Asia-Pacific Conference
  • Commenced an online survey for General Practitioners on participation in clinical trials (this closes on 30 September 2015)
  • Held a Human Research Application Form Advisory Group Meeting
  • Presented on the development of the HREA at a Deputy Vice Chancellors of Research Meeting
  • Published an article in the Medical Journal of Australia
  • Attended a CTAC Communications Working Group Meeting
  • Held a Good Practice Process Pilot initiation Meeting in WA
June 2015
  • Presented at 2 Clinical Trials Jurisdictional Working Group and Industry Liaison meetings
  • Attended a IHPA Clinical Trials Costing Study Steering Committee meeting
  • Held a Clinical Trials Portal Advisory Committee Meeting
  • Held a Human Research Application Form Content Advisory Group Meeting
  • Reported to the Clinical Trials Jurisdictional Working Group
  • Held Good Practice Process Pilot initiation Meetings in NSW, VIC, QLD, SA, TAS and the ACT.
  • Completed a public consultation on the Clinical Trials Ready initiative (this closed on 26 June 2015.)
  • Held a meeting with the Consumer Health Forum
  • Held a meeting with the TGA around the need for consistency in safety monitoring and reporting arrangements for clinical trials
May 2015
  • Presented at the ARCS Conference
  • Attended a IHPA Clinical Trials Costing Study Steering Committee meeting
  • Promoted International Clinical Trials Day
  • Held a Research Governance Working Group Meeting
  • Held a Human Research Application Form Advisory Group Meeting
  • Held a Good Practice Process Pilot initiation Meeting
  • Held a public consultation on the Clinical Trials Ready initiative (this will run until 26 June 2015.)
April 2015
  • Attended a IHPA Clinical Trials Costing Study Steering Committee meeting
  • Presented at the Australian and New Zealand Musculoskeletal Clinical Trials Group Summit
  • Presented at the Australasian Research Management Society Special Interest Group Meeting
  • Published an article in the Australasian Association for Academic Primary Care Inc
  • Commenced a public consultation on the Clinical Trials Ready initiative
March 2015
  • Held a Research Governance Working Group Meeting
  • Attended a IPHA Clinical Trials Costing Study Steering Committee meeting
  • Held a Human Research Application Form Advisory Group Meeting
  • Attended by teleconference a Group of Eight Research Integrity Group meeting
  • Presented at the Victorian HREC roundtable meeting in Melbourne
  • Presented at the New South Wales HREC Executive Officer and Research Governance Officer Roundtable Meeting
  • Reported to the Clinical Trials Jurisdictional Working Group
February 2015
  • Reported to the Clinical Trials Jurisdictional Working Group
  • Held a Clinical Trials Portal Advisory Committee Meeting
  • Reported to the Clinical Trials Advisory Committee
  • Held a Human Research Application Form Advisory Group Meeting
  • Conducted a targeted consultation on Updating Arrangements for Safety Monitoring and Reporting of Clinical Trials in Australia
  • Conducted a targeted consultation on the feasibility of an HREC Credentialing system