Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach
Abstract
:1. Introduction
2. Protocol Development, Study Startup and Enrolment
2.1. Protocol Development
2.2. Study Database
2.3. Rapid and High-Volume Enrolment
2.3.1. Strategies for Clinician/Referrer Engagement
2.3.2. Patient Engagement—Initial
3. Ongoing Study Conduct and Patient Engagement
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Protocol Design Role | Institution |
---|---|
Clinical and statistical protocol development | Monash Health, Victoria |
Biostatistics | The Kirby Institute, New South Wales |
Neutralising antibody procedures | The Kirby Institute, New South Wales |
Peripheral blood mononuclear cell procedures | QIMR Berghofer, Queensland The Kirby Institute, New South Wales |
Epigenetic testing | QIMR Berghofer, Queensland |
Paediatric clinical design | Sydney Children’s Hospitals Network, New South Wales Monash Health, Victoria |
Protocol Version | Date | Changes |
---|---|---|
Version 1 | 26 May 2021 | Original draft |
Version 2 | 8 June 2021 | Reduced number of patient visits in response to HREC and consumer representative feedback |
Version 3 | 3 August 2021 | Provision for 3rd dose |
Version 4 | 25 August 2021 | Provision for inclusion of children aged 12 and over |
Version 5 | 2 September 2021 | Minor adjustments during ethical review |
Version 6 | 11 October 2021 | Provision for inclusion of children aged 5 and over |
Version 7 | 27 January 2022 | Provision for 4th dose, and updated agile framework to incorporate surveillance after potential future additional doses without further protocol amendment |
Enablers | |
Participant engagement | |
Integration with routine care | Routine blood tests offered at time of appointment Appointments adjusted to coincide with routine care visits or treatments |
Provision of emerging vaccine information | Participants were provided phone or in-person updates of relevance to them from ATAGI guidelines, such as eligibility for 3rd, 4th and 5th primary and booster vaccine doses |
Provision of information in patient’s language | Routine use of interpreters for non-English-speaking patients |
Provision of study updates | Patient newsletters |
Avoidance of multiple calls to patients | Use of electronic medical records (e.g., My Health Record [25] to verify healthcare visits during safety monitoring and vaccination doses which may have occurred outside the study site |
Analysis | |
Identification of processing issues | Batched analysis with real-time feedback to participating sites regarding sample quality |
Challenges | |
Slower startup at some sites | Startup was later at some secondary sites due to contractual issues, resulting in delays in enrolment and fewer potentially eligible unvaccinated participants |
Community transmission by the time of vaccine approval for adolescents | Rapid rollout of vaccines to young people occurred due to widespread community transmission of the Delta variant at the time of vaccination approval, limiting the number of eligible adolescent participants Addressed prior to enrolment of younger children by protocol update and approval prior to vaccine approval in this age group, to allow immediate enrolment as soon as vaccine was approved |
Parental hesitancy for very young children | Blood tests are a concern for parents of very young children, which could potentially be addressed in the future by the development of assays for finger-prick blood testing. Perceived lack of severity of COVID-19 infection for very young children reducing vaccination uptake. |
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Body, A.; Milch, V.; McSorley, L.; Lal, L.; Ahern, E.; Ryan, R.; Jones, G.; Keefe, D.; Segelov, E. Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach. Vaccines 2022, 10, 2003. https://doi.org/10.3390/vaccines10122003
Body A, Milch V, McSorley L, Lal L, Ahern E, Ryan R, Jones G, Keefe D, Segelov E. Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach. Vaccines. 2022; 10(12):2003. https://doi.org/10.3390/vaccines10122003
Chicago/Turabian StyleBody, Amy, Vivienne Milch, Lynda McSorley, Luxi Lal, Elizabeth Ahern, Regina Ryan, Gayle Jones, Dorothy Keefe, and Eva Segelov. 2022. "Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach" Vaccines 10, no. 12: 2003. https://doi.org/10.3390/vaccines10122003
APA StyleBody, A., Milch, V., McSorley, L., Lal, L., Ahern, E., Ryan, R., Jones, G., Keefe, D., & Segelov, E. (2022). Rapid Protocol Development, Study Startup and Enrolment of a Prospective Study of COVID-19 Vaccination for Patients with Cancer: A Collaborative Approach. Vaccines, 10(12), 2003. https://doi.org/10.3390/vaccines10122003