Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2024

Protocol investigator teams – where are the nurses? A retrospective audit of collaborative clinical trial protocols (#240)

Belinda S Fazekas 1 , Angela Rao-Newton 2 , Anna Dowd 3 , Annmarie Hosie 4 , Linda Brown 5 , Jane Phillips 6 , Julie Wilcock 7 , Robin O'Reilly 7 , Indy Khera 8 , Kathryn Robinson 9 , Rayan Saleh Moussa 1
  1. University of Technology Sydney, Ultimo, NEW SOUTH WALES, Australia
  2. School of Nursing, University of Tasmania, Launceston, Tasmania, Australia
  3. Palliative Care, Barwon Health, Geelong, Victoria, 3220
  4. Nursing, The University of Notre Dame , DARLINGHURST , NSW, Australia
  5. Translational Research, Clinical Trials, Strategic Projects & Response, Safer Care Victoria, Melbourne, Victoria, Australia
  6. School of Nursing, Queensland University of Technology (QUT), Brisbane, Queensland, Australia
  7. Applied Medical Research, Ingham Institute, Liverpool, NSW, Australia
  8. Centre for Palliative Care, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
  9. Medical Oncology, Austin Health, Heidelberg, Victoria, Australia

Introduction

Study coordinators/nurses play a critical role in operationalising trial protocols but are rarely involved in protocol development, even in collaborative trial groups. The Palliative Care Clinical Studies Collaborative (PaCCSC) and Cancer Symptom Trials (CST) protocols are developed, as per GCP guidelines, ensuring that clinical, statistical, management, consumer, and specialist expertise are included in investigator teams from trial conception. Once developed, and ethically approved, protocols are presented to sites for implementation. At this stage, study coordinators/nurses have an opportunity to review the protocol and plan screening, recruitment, and trial management. At this point, important issues are often identified, resulting in amendments, protocol deviations, or multiple screening failures.

Aim

1)To identify the proportion of trial amendments that were related to a nursing issue and potentially avoidable

2) To identify the proportion of study coordinators/nurses listed as investigators on PaCCSC/CST protocols.

 

Methods

A retrospective audit of completed PaCCSC/CST protocol amendments from 2013-2023. Reasons for each amendment were assessed as being related to nursing input, or not. Items including: 1) questions around clarity, 2) scheduling issues 3) difficulties with the description of the intervention, 4) requirement for further explanation of data collection or assessment were classified as protocol issues potentially avoidable by early nursing review. Data were reported using descriptive statistics.

Results

 

A total of 17 study protocols were reviewed. The proportion of nurses listed as investigators on a protocol was 35% (n=6). Of 70 amendments, 34% were related to nursing issues including study visits, data collection, implementation questions, inclusion/exclusion criteria, drug/randomisation, or assessments.

Conclusions

Several costly amendments may have been avoidable if nurse input had been included from inception. Further research is being undertaken to explore the role of nurses in protocol investigator teams and to understand the impact of the inclusion of a nurse in this role.