Current practices, challenges, and future directions in subcutaneous oncology monoclonal antibody delivery: A qualitative study

Abstract

Background

Subcutaneous oncology monoclonal antibodies (SCOmAbs) offer significant benefits compared to intravenous formulations, including reduced administration time and potential for self-administration. However, little has been published on real-world preparation and administration practices with these novel formulations.

Methods

This was a qualitative, exploratory study of 30 participants (10 patients receiving SCOmAbs, 10 nurses, and 10 pharmacists/pharmacy technicians) across various U.S. healthcare facilities. One-on-one, in-depth interviews examined current practices, pain points, device integration potential, projected impact of increased SCOmAb adoption, and perspectives on home administration.

Results

Findings revealed considerable variability in SCOmAb preparation and administration practices. While preparation methods generally aligned with typical parenteral workflows, notable deviations included bedside preparation by nurses (7/30), use of syringe pump modules (3/19), and one case of patient self-administration at home. Most participants utilized closed-system transfer devices (12/22) despite inconsistent hazardous drug treatment between facilities. Administration challenges included ergonomic difficulties for nurses during manual push (5/9 reporting physical discomfort) and variable injection techniques to accommodate patient comfort. Nurses reported significant workflow impact from being “tethered” to patients during administration, which could require staffing adjustments as SCOmAb frequency increases. Most patients (6/9) expressed interest in home administration for potential time savings and flexibility, though concerns about training, support, and safety were common.

Conclusions

As SCOmAb utilization expands, facilities may face barriers associated with increased demand that could necessitate innovative solutions. To leverage the full potential of SCOmAb products, developers should consider how next generation product presentations might minimize identified pain points, streamline administration, and facilitate safe transition to home self-administration. Delivery device integration, whether through prefilled syringes, portable infusion pumps, or other delivery systems, may address current challenges but requires careful consideration of facility infrastructure, product complexity and usability, workflow impact, and patient training requirements.

This Zenodo record is a permanently preserved version of a Structured PREreview. You can view the complete PREreview at https://prereview.org/reviews/21310206.

Does the introduction explain the objective of the research presented in the preprint? Yes The introduction clearly explains the objective of the study by describing the increasing adoption of subcutaneous oncology monoclonal antibody therapies, the operational and clinical challenges associated with their preparation and administration, and the limited understanding of real-world stakeholder experiences.

Are the methods well-suited for this research? Somewhat appropriate The qualitative interview methodology is generally suitable for exploring current practices, stakeholder experiences, and perceived challenges associated with subcutaneous oncology monoclonal antibody administration. Including patients, nurses, pharmacists, and pharmacy technicians provides useful multidisciplinary perspectives. However, the methods have several limitations. The manuscript provides limited detail on codebook development, thematic analysis, independent verification, and measures used to reduce researcher bias. Coding appears to have been conducted primarily by a single researcher, and responses from different stakeholder groups are sometimes combined despite differences in their knowledge and responsibilities. The small, heterogeneous sample and reliance on self-reported experiences also limit the generalizability of the findings. Overall, the methods provide a reasonable basis for identifying themes and generating hypotheses, but they are not sufficiently rigorous to support broad conclusions about prevalence, device effectiveness, or optimal future delivery approaches.

Are the conclusions supported by the data? Somewhat supported The conclusions are generally consistent with the interview findings and appropriately identify perceived challenges related to manual administration, workflow burden, device needs, and interest in home administration. However, some statements appear broader than the data can fully support. The study is based on a small, heterogeneous sample, self-reported experiences, and conceptual reactions to potential delivery devices. Therefore, the findings support identifying unmet needs and generating hypotheses, but they do not establish the prevalence of these challenges or demonstrate that specific device solutions would improve workflow, safety, or scalability. The conclusions would be stronger if they more clearly distinguished participant perceptions from demonstrated outcomes and used more cautious language regarding device effectiveness and home-administration feasibility.

Are the data presentations, including visualizations, well-suited to represent the data? Somewhat appropriate and clear The tables and figures effectively summarize participant characteristics, interview themes, and reported practices, making the qualitative findings generally easy to follow. The use of quotations also helps support the identified themes and provides useful context. However, several improvements would enhance clarity. Responses from different stakeholder groups are occasionally aggregated despite differences in their roles and expertise, making some percentages and comparisons difficult to interpret. Additional stratification by participant type (e.g., patients, nurses, pharmacists, and pharmacy technicians) and, where feasible, by product or administration setting would provide clearer context. Including a simple thematic framework or conceptual model illustrating the relationships between workflow challenges, unmet needs, and proposed future delivery solutions would further strengthen the presentation of the results.

How clearly do the authors discuss, explain, and interpret their findings and potential next steps for the research? Somewhat clearly The discussion clearly summarizes the key themes identified from the interviews and appropriately highlights opportunities to improve subcutaneous oncology monoclonal antibody delivery through workflow optimization and future delivery technologies. The authors also acknowledge several study limitations and identify potential directions for future research. However, portions of the discussion could better distinguish participant perceptions from evidence-based conclusions. Some proposed solutions, including large-volume prefilled syringes, portable infusion devices, and home administration, are presented with greater confidence than the qualitative data support. A more balanced discussion of formulation, device compatibility, human factors, regulatory considerations, and the need for quantitative validation would strengthen the interpretation and provide a clearer roadmap for future research.

Is the preprint likely to advance academic knowledge? Somewhat likely This preprint provides useful real-world insights into current clinical practices and stakeholder experiences surrounding subcutaneous oncology monoclonal antibody administration, an area with limited published qualitative evidence. By incorporating perspectives from patients, nurses, pharmacists, and pharmacy technicians, the study identifies practical workflow challenges, ergonomic concerns, and unmet needs that may help inform future device development and implementation strategies.

Would it benefit from language editing? No

Would you recommend this preprint to others? Yes, but it needs to be improved This preprint addresses a clinically relevant and timely topic with practical implications for oncology drug delivery and future device development. The multidisciplinary perspectives from patients, nurses, pharmacists, and pharmacy technicians provide valuable real-world insights into current workflows and unmet clinical needs. Before publication, the manuscript would benefit from improvements in several areas, including greater transparency of the qualitative methodology, clearer separation of participant perceptions from evidence-based conclusions, more cautious interpretation of proposed delivery solutions, and expanded discussion of formulation, device compatibility, human factors, and regulatory considerations. Clarifying these aspects would strengthen the scientific rigor and improve the applicability of the findings.

Is it ready for attention from an editor, publisher or broader audience? Yes, after minor changes

Competing interests

The author declares that they have no competing interests.

Use of Artificial Intelligence (AI)

The author declares that they did not use generative AI to come up with new ideas for their review.

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Current practices, challenges, and future directions in subcutaneous oncology monoclonal antibody delivery: A qualitative study

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