Developing a research concept

TOGA welcomes clinical and translational investigator-initiated research proposals that aim to reduce the incidence, morbidity and mortality of thoracic cancers, and improve the quality of life of patients, their carers and families.

Development, review and endorsement of research concepts

TOGA strives to achieve and maintain a reputation for designing, conducting and publishing high-quality clinical trials and research that contribute to evidence-based health care in thoracic malignancies.

To ensure only high-quality and feasible clinical trials and research studies are conducted by TOGA and to maximise the benefit of peer-review it is necessary to outline a policy and process for TOGA approval of a study concept, or application for secondary use of data or research proposal. This process typically comprises peer- and consumer- review of the study proposal, assessments that the study is feasible and support for the study by the wider membership.

In TOGA, peer-review and development are conducted by the working groups and/or research panel with a recommendation to the TOGA Scientific Committee to approve the proposal.

The working groups and research panels are as follows:

  1. Early non small cell lung cancer
  2. Advanced non small cell lung cancer
  3. Small cell lung cancer/mesothelioma
  4. Supportive and palliative care
  5. Translational research

If you are interested in joining a working group, please nominate here

Developing research and clinical trial concepts

Once a preliminary approval is obtained, supplementary reviews by the Consumer Panel, the supportive care panel, the translational research panel and the Cancer Australia- appointed national technical services for health economics and Quality of Life, and the likelihood of adequate funding, may contribute to the Scientific Committee decision to provide final approval of a proposal. This process is illustrated in the schematic above.

Brown skinned male with beard and shaved head. He wears glasses and a dark suit jacket with light coloured tie

Submission of a research concept

Research concepts can be submitted either as a clinical trial concept, synopsis or a brief paragraph to info@thoraciconcology.org.au

A guide to developing a concept can be accessed here. Other useful tools for protocol development include the SPIRIT checklist for defining standard items for inclusion in clinical trial protocols, and for Patient-Reported Outcomes (PRO), the SPIRIT-PRO checklist. PRECIS-2 can help trialists make design decisions consistent with the intended purpose of their trial.

Further assistance can be obtained by contacting info@thoraciconcology.org.au

In advance of any Scientific Committee meeting, TOGA members will be emailed and social media posts distributed that advertise the deadline date for submissions for the next meeting. Submitted concepts will undergo a preliminary review, and submitting investigators will be contacted notifying them of the details for presentation. It is expected that presentations will be less than 10 mins and cover the following:

  • Background and rationale including evidence of a search that there are no current or past research projects that answer the same question, or in the case of a trial, that will compete for local recruitment
  • Aim/hypothesis
  • Trial treatment and any points where it does not align with local standard of care treatment or summary of research project
  • Research population
  • Study design (consider a schema)
  • Statistics including endpoint/objectives and, if possible, power calculation
  • Potential significance of research project or clinical trial results, and feasibility of implementation of results after the research project is completed
  • Feasibility and key questions for consideration

TOGA endorsement of a research concept

The approval of a research proposal by the TOGA Scientific Committee is referred to as TOGA endorsement. In TOGA a clinical trial can be endorsed, or both endorsed and led by the group, with the latter offering oversight by the TOGA Operations Executive Committee throughout the clinical trial. Research proposals that are not clinical trials can only be endorsed by TOGA, with responsibility for the research conduct remaining with the Investigator. TOGA also welcomes proposals from members for participation in international investigator-initiated clinical trials.

TOGA endorsement offers the following benefits:

  • Use of TOGA logo or TOGA acknowledgment on all applications, presentations and publications
  • Membership mailouts to assist with recruitment
  • Listing of trial on the TOGA website
  • Updates presented at Scientific Committee or other TOGA meetings (time permitting)

Further information is available in the TOGA Endorsement Policy.

Other useful resources

Trial Forge Resources for Studies within a Trial.

The SPIRIT Statement providing evidence-based recommendations for the minimum content of a clinical trial protocol.

The SPIRIT PRO extension providing guidance for designing patient-reported outcome studies