So you’ve got a great research idea, something that could change clinical practice, improve patient outcomes, or fill a crucial evidence gap but you’re not sure where to start. Turning that idea into a fully fledged investigator-initiated clinical trial (IIcT)- sometimes called a clinician-led clinical trial- can seem daunting, but every successful trial began with one simple question: What do I want to know, and why does it matter?
This post outlines the key steps in getting started with an IIcT — from defining your niche to pitching your concept and building the right infrastructure around it.
Define Your Research Question
An IIcT starts with a clinically meaningful question- one that matters to patients and clinicians, and hasn’t already been answered.
Use the PICO framework to focus your idea:
- P – Patient or Population
- I – Intervention
- C – Comparison or Control (leave this out for a single arm study)
- O – Outcome
You can further refine your question by joining TOGA working group brainstorming sessions, where experienced trialists discuss evidence gaps and trial ideas. In these meetings, the clinical trial design is often documented as a schema, which can be a great way to articulate your concept in one picture. See template to easily prepare a trial schema.
Consider endpoints around quality of life, cost-effectiveness or other clinically relevant measures, as well as response, progression-free survival and overall survival.
Ask yourself:
- Does the idea have a sound scientific rationale? This should enable you to create your hypothesis.
- Is this idea relevant? You can seek preliminary feedback from peers or consumers.
- Is it novel? Conduct a basic review of existing literature and clinical trials from WHO registries.
- Is the study feasible as an IIcT? Noting that IIcTs often run at sites below cost recovery, and there is usually another ‘carrot’ for recruitment such as a drug or test not yet available as SOC.
Pitch Your Concept to Peers and Seek TOGA Endorsement
This is the start of your research concept development phase, moving from an idea to a testable study design. Once you’ve clarified your idea, the next step is to test it among peers, both to refine the question and to assess feasibility.
At this stage, you can submit your concept through TOGA’s “Develop Your Research” pathway.
When you submit your concept to TOGA:
- TOGA will arrange a statistical consultation to check your sample size calculation if you have not already used a qualified statistician. You will need:
- effect size or clinical difference you hope to detect,
- duration of follow-up and recruitment,
- proposed endpoints (primary and secondary), and
- any stratifications.
Consult Kirby et al (2002) ‘Determining the sample size in a clinical trial’ for more information.
- You will be invited to present your concept to the relevant TOGA working group, which includes multidisciplinary experts in thoracic oncology. This review process provides peer- and consumer-review.
- You can apply for TOGA endorsement, a mark of scientific quality and community support.
- TOGA can ask their network of consumers if anybody would like to be further involved in the research proposal
How does TOGA Endorsement Help?
TOGA endorsement signifies the approval of your thoracic oncology research proposal by our Scientific Committee.
This endorsement offers a range of benefits to support your research endeavours:
- Peer and consumer review: Your proposal is reviewed by a panel of experts in thoracic oncology, including both clinicians and consumer representatives. You may find that during this review somebody gives such helpful feedback that you consider them as part of your research team.
- Access to research support: TOGA facilitates services such as statistical design, review for health economics design and review of incorporation of QoL.
- Credibility and recognition: You can leverage TOGA’s reputation to strengthen funding applications and publications.
- Enhanced visibility: Endorsed projects gain exposure via TOGA’s website, newsletters, and meetings, helping with recruitment and collaboration.
Once endorsed, you’ll also begin to form your core team of lead investigators who can assist with protocol development, grant writing, and trial oversight. Investigators should bring both a track record and a particular expertise to strengthen your grant team.
The process of TOGA working group review can also gauge who might become recruiting investigators once the trial opens. TOGA can also assist with this process by sending out feasibility surveys. See the Master feasibility survey design template, which can be modified or significantly shortened for preliminary interest and feasibility.
Benefits of Consumer Involvement
Involving consumers (patients, carers, and community members) in clinical trial design strengthens research by ensuring studies reflect the real experiences and priorities of people living with the disease.
Key benefits include:
More relevant research questions
Consumers bring lived experience of disease and care pathways. This helps researchers prioritise research questions and endpoints that matter to patients, rather than only academic or technical outcomes.Improved trial design and feasibility
Consumer input can identify practical barriers such as visit frequency, travel burden, or complex procedures. Addressing these early can make trials easier for participants to join and complete.Better recruitment and retention
Trials designed with consumer input tend to be easier to understand and participate in. Studies suggest consumer involvement can increase participant enrolment and improve retention.Clearer participant materials
Consumers help refine patient information sheets, consent forms, and recruitment materials so they are understandable and relevant rather than overly technical.
Many grants now allocate a score to your consumer and community involvement. Learn how to write a winning consumer involvement grant application in a free course.
Understand the Role of a Trial Centre
A trial centre (also known as a coordinating centre) plays a critical role in ensuring your IIcT runs smoothly and meets regulatory standards. Trial centres typically assist with:
- Sponsor obligations
- Protocol development and scientific input
- Trial registration (e.g., ANZCTR)
- Budget preparation and review of contracts
- Site selection and start-up, including HREC and governance submissions, PICF development, and regulatory notifications (CTN)
- Data management, including CRF and database design, and randomisation processes
- Monitoring and quality assurance, including source data verification and compliance checks
- Safety oversight and serious adverse event reporting in collaboration with investigators
They also provide operational support throughout the trial lifecycle, allowing investigators to focus on scientific leadership rather than administrative coordination.
If using a trial centre, obtain a quote for their services. Most trial centres will enter into a confidentiality agreement prior to quoting. This is important to protect your Intellectual Property (IP) and to ensure confidentiality. If you cannot identify a trial centre or Sponsor, contact TOGA.
Plan Your Trial Budget and Funding
Determine your trial budget. This can be done by requesting quotes from trial centres, using a costing template or considering these cost drivers in multisite IIcT. If a statistician is not part of your trial centre quote, you may like to consult ACTA STiNG Network’s guide for a trial statisician. A well-structured budget also helps you identify which costs will recur annually and which are once-off set-up expenses, and significantly strengthens the feasibility of any funding application.
Applying for Clinical Trial Grants and Funding
Identify your funding sources. This could be a pharmaceutical company or relevant grant opportunities. Explore government and philanthropic grant funding for clinical trials, especially for IIcTs.
TOGA provides support in identifying relevant grants and assist with grant submissions (e.g. writing or structure), but is not an NHMRC-accredited institution to make the submission for NHMRC or MRFF grants. You will need to identify the submitting institution, and any requirements they may have for reviews prior to submission.
Expect setbacks at this stage: Rejection is not failure but part of the learning curve. Learn to accept critical feedback and persist with refining and resubmitting.
Build your Research Niche While Awaiting Funding
Below is an indicative timeline showing the typical stages of an investigator-initiated trial, from concept through to completion:
Once your plan and costing are in place, you can start preparing your evidence base and building your research niche. Building a niche is key to becoming a credible investigator. Funders, collaborators, and peer reviewers all look for a track record of focused expertise.
Start by publishing what you can:
- Case reports or case series that highlight real-world challenges or novel responses.
- Systematic reviews or meta-analyses that identify gaps in the evidence base.
- Conference abstracts or audit data that build your reputation and citations.
Consider a small-scale pilot study with a smaller funding source to demonstrate feasibility in a grant application for the full clinical trial budget.
These publications help you refine your research question and can later be referenced in grant applications. Over time, this body of work signals that you understand the clinical landscape and can lead research in your chosen area.
Lead with Impact During the Clinical Trial
As the principal investigator, you’ll remain closely involved throughout the investigator-initiated clinical trial. Expect to play an active role in:
- Site initiation: the lead PI may be asked to deliver part of all of the site initiation visit presentation.
- Safety oversight including serious adverse event (SAE) review for causality and expectedness, and Investigator’s Brochure Review
- Documentation sign-off such as protocol and Participant Information and Consent Forms (PICF) and any amendments
- Trial queries from other recruiting medical practitioners
- Promoting recruitment by contacting colleagues recruiting to the clinical trial
- Publication planning and authorship oversight
Your leadership ensures that the study maintains its scientific integrity, complies with Good Clinical Practice, and delivers impact to patients and the thoracic oncology community.
FAQs
An IIcT is a study designed and sponsored by clinicians or research groups rather than industry, often addressing important gaps in evidence.
Submit your concept via the Develop Your Research pathway for peer and consumer review by TOGA’s Scientific Committee.
A coordinating centre helps manage sponsor responsibilities, compliance, and trial data integrity.
Final Thoughts
Starting an IIcT is both challenging and rewarding. It requires curiosity, persistence, and collaboration- but it’s also one of the most powerful ways clinicians can drive change in patient care.
If you’re based in Australia or New Zealand and have an idea for a thoracic oncology IIcT, TOGA can help you take the first step.
Contact us through info@thoraciconcology.org.au We support our members in turning promising ideas into practice-changing thoracic oncology research.
