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Clinical trials

Clinical trials

Clinical trials at Starship are run with industry, universities, and clinicians. They help children and young people access new treatments while meeting high standards for safety, ethics, and data quality.

All trials follow approved plans and closely monitor patient outcomes to make sure the research is safe, reliable, and helps improve healthcare in the future.

Clinical trial enquiries

We welcome enquiries from sponsors, CROs and collaborative groups who are interested in conducting clinical trials at Starship. We have dedicated research personnel and experienced investigators working across a wide range of paediatric specialities.

Our team provides a range of services to support Starship staff in developing and delivering clinical trials and research projects. Visit the Research Support page to learn more.

General contact / feasibility enquiries: starshipresearch@adhb.govt.nz

Clinical trial approvals - Medsafe approval for clinical trials involving new medicines

Under section 30 of the Medicines Act, approval from the Director-General of Health is required before a clinical trial using a new medicine may commence in New Zealand. A new medicine is defined as a medicine that does not otherwise have approval to be distributed in New Zealand.

Medicines regulatory approval is administered by Medsafe via The Standing Committee on Therapeutic Trials (SCOTT). Applications are made through the same Ethics RM system as HDEC applications.

Approvals under other legislation may be required for clinical trials using certain types of medicines (i.e. gene technologies and other biological therapies via the Gene Technology Advisory Committee).

Good Clinical Practice

All clinical trials conducted in New Zealand are expected to be conducted in accordance with internationally accepted standards for Good Clinical Practice (GCP), as outlined in ICH E6(R3): Guideline for Good Clinical Practice [ICH E6(R3]).

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

Investigators conducting clinical trials are required to have current evidence of GCP training. We recommend that researchers look for a globally accepted TransCelerate approved GCP training course. Suggested courses include: