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Rural, regional & remote clinical trial support units

Improving access to innovative healthcare across NSW and ACT

Call for Expressions of Interest to establish three rural, regional and remote clinical trial support units are now open

Expressions of interest close 15 March 2021

As part of the Rural, Regional and Remote Clinical Trials (RRR CT) Program, funded under the Medical Research Future Fund – Rural, Regional and Remote Clinical Trial Enabling Infrastructure Grant, NSW Health is planning to establish a network of up to three regional, rural and remote clinical trial support units (R3CTSUs) to deliver increased and more equitable access to clinical trials for patients in rural, regional and remote (R3) NSW.

The R3CTSUs will be responsible for facilitating and delivering clinical trials across all NSW and ACT MMM3-7 populations, working with centralised functions led out of the NSW Ministry of Health, clinicaltrialsNSW.

NSW Ministry of Health invites local health districts (NSW) and health services (ACT) covering MMM3-7 populations to apply for funding to establish and implement a R3CTSU in up to three clusters covering the northern, western, and southern NSW/ACT region. Each cluster must be representative of all local health districts (NSW) and health services (ACT) within these regions.

Each Host Organisation, either an LHD (NSW) or health service (ACT), may apply for funding up to $6 million over 4 years per region. The maximum funding available for the network of R3CTSUs in up to three clusters is a total of up to $18 million over 4 years.

NSW Health will determine the funding amount awarded based on several factors, including but not limited to population size, clinical trial portfolio, perceived growth and clinical trial support unit staffing required.

Eligibility criteria

The Expression of Interest (EOI) must be led by a Research Director at an eligible host organisation or a clinical trials champion nominated by an eligible host organisation in collaboration with local health districts (NSW)/ health services (ACT) within the cluster. The Research Director or clinical trials champion will drive and oversee the development and operationalisation of the R3CTSU, reporting to clinicaltrialsNSW.
Eligible host organisations include:

  • NSW local health districts covering MMM3-7 populations
  • ACT health services supporting MMM3-7 populations

The R3CTSU can be co-located across the local health districts (NSW)/ health services (ACT) covering the cluster.

The R3CTSU must support all local health districts (NSW)/ health services (ACT) within the cluster.

Application and selection process

Stage 1: Call for EOIs

Call for EOIs will open and the EOI application guidelines and form will be live on the OHMR website on 1 February 2021.

NSW Ministry of Health in collaboration with ARCS Australia held a webinar to support applicants on 9 February 2021. The webinar:

  1. outlines the intent of the RRR CT Program and the network of up to three regional, rural and remote clinical trial support units
  2. provides insight into what reviewers are looking for in EOIs
  3. provides an overview of the EOI application and selection process.

Watch ARCS webinar

Download transcript of ARCS webinar

NSW Ministry of Health in collaboration with Praxis Australia will host a Q&A session to support applicants 12.30pm-1.30pm on 12 February 2021.

The webinar will be a structured session to run through questions submitted by applicants to clinicaltrialsNSW@health.nsw.gov.au as well as to run through any questions in the session.

Register for Praxis Australia webinar

Download FAQ slides from Praxis Australia webinar

Chief Executive Authorisation

The Host Organisation must obtain authorisation and sign off from the Chief Executive of the Host Organisation and partner local health districts (NSW) and health services (ACT) in advance of the submission deadline. Additional time has been built into the EOI development phase to allow this to occur, between 8 March 2021 to 12 March 2021.

Submission

The expression of interest form, excel template and attachment(s) must be submitted by the point of contact at the Host Organisation (listed in the EOI Form under question A4) by email to clinicaltrialsNSW@health.nsw.gov.au by 5pm, 15 March 2021.

Please note single emails larger than 20MB will be blocked.

Stage 2: Review of EOIs

  1. Eligibility check – Expressions of Interests will undergo initial review by NSW Health to ensure eligibility criteria are met.
  2. EOI review – The EOIs will be reviewed by the RRR CT Selection Panel against the selection criteria in the Application Guidelines.
  3. Recommendation to NSW Health – The review process will result in recommendations to NSW Health who will make a final decision on funded applicants and amounts.

Stage 3: Notification of Outcomes

All applicants will be informed as to whether they have been awarded funding. This decision is final and may not be appealed.

Timelines

Key dates for the EOI for the R3CTSUs are below.

Stage  Date
Call for EOIs 1 February 2021
Webinar to support applicants 9 February 2021
Q&A Webinar hosted to support applicants 12 February 2021
Sign off period by Chief Executive of Host Organisation and Partner local health districts 8-12 March 2021
EOIs submitted to NSW Ministry of Health 15 March 2021
Assessment of EOIs by the Selection Panel April 2021
Notification of outcomes April May 2021

More information

To receive updates on this funding opportunity, please subscribe to our email list and select the RRR Clinical Trial Program interest area. If you are already subscribed, please update your profile by adding the RRR Clinical Trial Program to your interest areas.

For further information or any questions, please contact clinicaltrialsNSW at clinicaltrialsNSW@health.nsw.gov.au

Apply now

  • Rural, regional and remote clinical trial support unit expression of interest form

    DOCX - 67 KB

  • Excel template for section B of the expression of interest form

    XLSX - 55 KB

Before you apply

The Guidelines outline:

  • vision of the rural, regional and remote clinical trial support network
  • program key activities and intended outcomes
  • responsibilities of the R3CTSUs
  • eligibility criteria
  • selection criteria
  • application and selection process
  • funding details and conditions
  • reporting requirements
  • program monitoring, quality assurance and auditing

The guidelines should be read in conjunction with the RRR CT project plan – improving access to innovative healthcare in rural, regional and remote NSW and ACT prior to completing the expression of interest.

 

Frequently asked questions

ELIGIBILITY

Do partner collaborating organisations listed in question B5 of the data form need to provide a letter of support?

Partner organisations that are supporting a responsibility within C3 of the R3CTSU proposal must provide a letter of support. Partner LHDs and/or ACT Health Services only require sign off from the Chief Executive.

SECTION B

Should we capture staff who are involved in both clinical care and clinical trials for question B2 of the data form?

Yes, please:

  • capture any staff who are involved in clinical trials at MMM3-7 trial sites as per trial delegation log, even if their role is not a full time/dedicated trial position
  • if the staff member is paid by an external source (i.e. not an LHD) but they have a StaffLink with the LHD and are undertaking trial related activities at a trial site in MMM3-7 (e.g. a co-Investigator who sees trial patients at a MMM3-7 trial site), please capture in the data form
  • add further information in the comments column to indicate they are providing clinical trial support outside of their core/funded role.

Should we include staff who are involved in clinical trials during a rotation, such as advanced trainees who are only at site for 6-12 months as part of their rotation, in question B2 of the data form?

Please include any staff involved in clinical trial activity across MMM3-7 trial sites.

In addition to LHD staff, are we required to list staff such as university employees who are involved in clinical trials for question B2 of the data form?

We are trying to capture all staff working on trials even if their salaries are paid by another organisation that is not the LHD.  As a guide, if they have a StaffLink ID and they are undertaking trial related activities at a trial site in MMM3-7 (e.g. are a co-Investigator who sees trial patients at a MMM3-7 trial site) they should be included. The requested information is to assist applicants and clinicaltrialsNSW to identify areas of unmet need or challenges facing the trial sector in RRR LHDs.

Does column N ‘career stage’ (i.e. early, mid or established) relate to clinical trial operations staff (e.g. Study Coordinators, Research nurses, etc.) or just Investigators within the LHD for question B2 of the data form?

The ‘Career Stage’ in column N for Q B2 of the data form only refers to researchers at post-doctorate level or higher.

‘Career Stage’ would need to be identified for Investigators.

Are only Clinical Trials required for question B4 in the data form or should Clinical Research, Health/Social Science Research also be included?

You should capture all activities that meet the definition of a clinical trial as outlined in the EoI Guidelines on (p4).

This is only required for trial sites located in MMM3-7 areas.

If MMM1-2 trial sites are providing teletrials should this data be included for question B4 of the data form?

Please list teletrial sites in MMM3-7 areas only. Add additional details in the comments section.

If trials have been running for longer than three years in MMM3-7 areas, should they be included in question B4 of the data form?

Yes please, trials that commenced more than 3 years ago but which are currently active, should be included in the Q B4 of the Data Form.

This includes trials that are closed to recruitment, but patients are in follow up or trials that are open at any stage in their lifecycle post CTRA/contract execution.

It excludes any trials that have been formally closed by a Sponsor through Ethics.

SECTION E

Can we include funding requests for roles such as a Fellowship, or a Research Assistant within the budget?

Neither Fellowships nor a Research Assistant are out of scope for the Expression of Interest. However, the proposal should clearly indicate the purpose of the roles and how they will address the unmet need in the cluster.

GENERAL PROGRAM

What phase clinical trials are envisaged for the Rural, Regional and Remote Clinical Trials Program (RRR CT Program)?

The RRR CT Program aims to grow the clinical trial portfolio across all phases as appropriate to the capabilities and needs of the LHD, researchers and community in RRR areas. Early phase trials are not excluded, however, it is acknowledged that early phase trials and other types of trials such as active implantable devices and advanced therapeutics may not be suitable for all clinical trial sites across NSW. Development of the portfolio in these specialist areas will be a process of partnership across the sector.

Will the education program that is being planned include hands on practical experience to RRR program CT staff?  And if not, is this something we should be ‘briefly’ identifying in our EOI?

The Program will include classroom style training (that may be virtual). This will be funded from the remaining grant components and will be developed with the CTSU post-establishment, based on training needs.

You are still able to include a request for funding resource, facilities or equipment to support education, training and development within your EOI. For example, a CTSU may want to consider allocating funding towards a Quality, Education and Training Manager.

Should resourcing plans for the EOI match the project plan submitted to MRFF?

The resourcing proposed for the CTSUs through the EOI should not be constrained by the elements originally outlined in the Project Plan submitted to the MRFF. You can submit a resourcing plan that meets the needs of your cluster partners.

Updated 9 months ago