The Role of Clinical Trials Every medicine must undergo rigorous clinical testing before it can be approved for use. Clinical trials are carefully designed research studies that evaluate the safety and effectiveness of new medicines in people. They are a vital step in the development process, helping researchers understand how a treatment works, determine the most appropriate dose, identify potential side effects and demonstrate whether it provides meaningful benefits for patients. Making Clinical Trial Participation Easier for Patients CSL incorporates flexible and decentralised options into clinical trial design to improve accessibility, reduce participant burden and promote equity. These options include electronic Clinical Outcome Assessments (eCOA) with Bring Your Own Device capability, eLearning, alternative locations for study procedures and telehealth visits. These features are designed to make participation easier and more inclusive, supporting improved recruitment and retention while enabling the collection of more robust and representative data. In FY26, 89% of Phase II/III studies included flexible options, which were recommended by patient advisors to reduce the burden on participants. HOW MEDICINE GETS FROM THE LABORATORY TO THE PHARMACY Trial Plan Developed and Reviewed After discovery of potential treatment, pre-clinical studies are conducted to ensure basic questions about its safety. Phase III The potential treatment is tested with an even larger group of people (1,000 – 3,000) to confirm effectiveness, monitor for side effects, compare it to commonly used treatments and collect information about safe use. Clinical Trials Begin For a treatment to be approved, it must pass a three-phase clinical trial process. Phase II The study treatment is tested with a larger group of people (100 – 300) to further evaluate safety and assess effectiveness. Results Evaluated Results of clinical trial are evaluated and submitted for review. Phase I Researchers test a new treatment with a small group of people (20 – 80) to evaluate safety, determine safe dosage range and identify side effects. Approval After a thorough review, regulatory agency may approve the new treatment for medical use. Phase IV: Post-Approval Marketing studies are conducted to gain additional insights about the treatment's risks, benefits and optimal use. | Introduction | For Patients | For Science | For Society | Looking Forward CSL IMPACT REPORT 2026 | 23
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