e-Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2021

Rapid startup of a clinical trial due to clinical urgency of the COVID-19 pandemic- lessons for future research. (#217)

Amy Louise Body 1 2 , Vivienne Milch 3 , Elizabeth Ahern 1 2 , Luxi Lal 1 2 , Eva Segelov 1 2
  1. Medical Oncology, Monash Health, Clayton, VIC, Australia
  2. Monash University, Clayton, VIC, Australia
  3. Cancer Australia, Surry Hills, NSW, Australia

Background:

SerOzNET (ACTRN 12621001004853) is a prospective study assessing serologic and immunologic response to COVID-19 vaccines in patients with cancer, and also evaluating hesitancy, patient-reported outcomes, and toxicity1,2. Patients are enrolled prior to their first COVID-19 vaccination. The study is partially funded by Cancer Australia (CA).

Study timeline:

In total, the time from the initial CA expression of interest to the first patient enrollment was 52 days.

Key dates

- 25-26 March 2021: CA wrote to key cancer control representatives in each State and Territory seeking expressions of interest to undertake a prospective study of vaccine response in patients with cancer, based on the United States National Cancer Institute (NCI) “SeroNet” framework3

- 14 May 2021: Submission of proposal to CA by Monash Health, including protocol based on the “SeroNet” framework and tailored to Australia, the “SerOzNET” study

- 26 May 2021: Following proposal review and panel assessment, contract offered to Monash Health. Protocol submitted to Monash Health Human Research Ethics Committee (HREC) (late submission granted under COVID-19 provisions)

- 3 June 2021: HREC meeting

- 6 June 2021: Feedback from HREC received, granting conditional approval pending amendments

- 9 June 2021: Formal response to HREC submitted, reviewed out of session due to COVID-19 provisions

- 22 June 2021: Final HREC approval

- 24 June 2021: Governance approval and site-specific agreement finalised

- 25 June 2021: First patient in SerOzNET enrolled

Collaboration:

Intensive national and international collaborations made this timeline possible included: the NCI “SeroNet” protocol being publicly available for collaborating researchers; communication by CA with stakeholders and researchers; collaborating researchers rapidly developing the protocol; and Monash Health HREC accommodating  late submission and out-of-session review of amendments.

Conclusion:

The COVID-19 pandemic has inspired unprecedented co-operation between researchers, funding bodies and health services. Future research can be informed by this experience.

  1. 1. First Australian clinical trial to study COVID-19 vaccines in patients with all cancers | Cancer Australia [Internet]. [cited 2021 Jul 7]. Available from: https://www.canceraustralia.gov.au/about-us/news/first-australian-clinical-trial-study-covid-19-vaccines-patients-all-cancers
  2. 2. Our Research | Monash Health [Internet]. [cited 2021 Jul 7]. Available from: https://monashhealth.org/services/oncology/our-research/
  3. 3. SeroNet Resources for Researchers and Clinicians | Center for Strategic Scientific Initiatives (CSSI) [Internet]. [cited 2021 Jul 6]. Available from: https://cssi.cancer.gov/seronet