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Why clinical trials and research take time

When you support research through Icon Cancer Foundation (ICF), your generosity helps lay the foundations for vital medical discoveries. But unlike a direct gift to a patient or piece of equipment, the impact of your donation may not be immediately visible. That’s because high-quality research takes time – and for good reason.

ICF exclusively funds investigator-initiated trials (IITs) – clinical studies designed and led by independent clinicians or researchers, not pharmaceutical companies. These trials often explore new uses for existing treatments, seek to improve standard care or test novel ideas that might not attract commercial interest.

Developing a clinical trial typically takes around 12 months, though this can vary depending on many factors, including finding funds and trial complexity. From the initial idea to ethics approval and recruitment, each step must follow strict scientific and ethical standards to protect patient safety, ensure data accuracy, and produce meaningful results.

What makes investigator-initiated trials different?

IITs may take longer than clinical studies sponsored by a pharmaceutical company or medical device manufacturer. Unlike pharmaceutical companies, research teams working on IITs often rely on competitive grants and limited resources. However, there are also advantages.

Close collaboration between researchers can lead to efficiencies, and consumer input is more easily incorporated to ensure the research is focused on real needs. Icon has specific processes to help coordinate this.

Understanding this process helps explain why your support is so valuable and why research, while not always fast, is essential for progress in cancer care. The time it takes is an investment in safety, scientific rigour and better outcomes for future patients.

Overview of the clinical trial process

Stage

Typical duration

Development of the study idea

4 weeks

Study protocol + synopsis development

10-28 weeks

Assessing each site’s feasibility

2-6 weeks

Ethical review

6-10 weeks

Site governance

6-14 weeks

Site training and activation

1-3 weeks

Total

27-65 weeks (6-15 months)

Detailed breakdown of the clinical trial development process

1. Development of the study idea

  • What happens:

    • A clinician or researcher develops the research question, defines the objectives and drafts a high-level study outline.

    • Concept is reviewed by peer groups, such as Research Committees and seeks management approval. 

    • Consumer input may be obtained at this point or may occur later.

  • Timeframe: 4–12 weeks

  • Note: This is often done outside of clinical hours. Timelines may be extended due to clinician workload, committee meeting schedules (some may only meet bi-monthly) or difficulty sourcing timely consumer input.

2. Full protocol and study document development and review

  • What happens: Development and review of detailed documentation, including the full protocol, statistical analysis plan, patient information, consent forms, and case report forms (used for data collection).

  • Timeframe: 6–16 weeks

  • Note: The availability of reviewers (e.g. statisticians, subject matter experts) and confirmation of funding can significantly influence the pace.

3. Site feasibility and selection

  • What happens: Assessment of whether Icon Cancer Centre sites have the capacity and capability to run the trial.

  • Timeframe: 2–6 weeks

  • Note: Multi-site trials may involve additional logistical considerations and take longer.

4. Ethics submission and review

  • What happens: The study is submitted to an external Ethics Committee (EC) for review, often requiring multiple revisions.

  • Timeframe: 6–10 weeks

  • Note: Delays may occur if investigators are managing revisions themselves or ethics committees are oversubscribed.

5. Site governance authorisation

  • What happens: The study is reviewed and approved at each participating site to ensure compliance with Icon’s governance requirements.

  • Timeframe: 6–14 weeks

6. Site initiation and trial activation

  • What happens: Final investigator and sites’ research team training is completed. All approvals are confirmed, and the trial is officially open for patient recruitment.

  • Timeframe: 1–3 weeks

7. Recruitment begins

  • Note: Some trials can last 2–15 years or more, depending on the phases of the clinical trial, the type of intervention, and whether it’s a single-site or multi-site study.