STC3141 - An Open Label, Multi-Centre Study to Determine the Safety and Efficacy of STC3141 Administered as an Infusion for up to 5 Days in Subjects with COVID-19 Respiratory Distress Syndrome Requiring Intensive Care [2020] NSWCATGD 16

STC3141 - An Open Label, Multi-Centre Study to Determine the Safety and Efficacy of STC3141 Administered as an Infusion for up to 5 Days in Subjects with COVID-19 Respiratory Distress Syndrome Requiring Intensive Care [2020] NSWCATGD 16

The Tribunal was satisfied that the clinical trial met all statutory requirements in s 45AA(2) as STC3141 is intended to alleviate COVID-19 ARDS, there was no known substantial risk, the drug had demonstrated safety in human volunteers, there were no alternative disease-specific treatments, the potential benefits outweighed risks, and the study was ethically approved. Accordingly, the Tribunal approved the clinical trial, with only the Tribunal able to provide consent for individual patients at this stage.

Parties
Applicant: Professor Anders Aneman
Jurisdiction
Australia
Judgment Date
24 April 2020
Procedural Posture
Guardianship Application for Approval of Clinical Trial / Determination of Approval for Clinical Trial Under S 45 AA of the Guardianship Act; Application for Person Responsible Consent Adjourned
Outcome
Clinical trial approved under s 45AA of the Guardianship Act 1987 (NSW); application regarding 'person responsible' consent adjourned.
Legal Topics
Clinical Trials on Incapacitated Adults, Consent to Medical Treatment, COVID 19 Treatment Research, Best Interests of Patients, Ethics Committee Approval
Guardianship Law Health Law Medical Research Ethics Clinical Trials on Incapacitated Adults Consent to Medical Treatment COVID 19 Treatment Research Best Interests of Patients Ethics Committee Approval

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Parties

Professor Anders Aneman

Applicant

Procedural Posture

Guardianship Application for Approval of Clinical Trial / Determination of Approval for Clinical Trial Under S 45 AA of the Guardianship Act; Application for Person Responsible Consent Adjourned

Legal Issues

  1. 1 Whether the clinical trial meets the statutory requirements for approval under s 45AA of the Guardianship Act 1987 (NSW)
  2. 2 Whether participation in the trial is in the best interests of COVID-19 ICU patients unable to consent
  3. 3 Whether the safety, ethics, and best interests criteria are satisfied to allow participation of incapacitated patients in a Phase II trial

Ratio Decidendi

The Tribunal was satisfied that the clinical trial met all statutory requirements in s 45AA(2) as STC3141 is intended to alleviate COVID-19 ARDS, there was no known substantial risk, the drug had demonstrated safety in human volunteers, there were no alternative disease-specific treatments, the potential benefits outweighed risks, and the study was ethically approved. Accordingly, the Tribunal approved the clinical trial, with only the Tribunal able to provide consent for individual patients at this stage.

Court Disposition

Clinical trial approved under s 45AA of the Guardianship Act 1987 (NSW); application regarding 'person responsible' consent adjourned.

Orders

  • The clinical trial (both Stage 1 and Stage 2) meets the requirements of section 45AA(2) of the Guardianship Act 1987 (NSW) and is approved pursuant to s 45AA(1).
  • Consent for medical treatment in course of the trial may only be given or withheld by the Tribunal (section 45AB(1)(b)).