OBJECTIVES: Pressing regulatory pressure from reduced timelines for oncology accelerated approvals has motivated researchers to adopt protocol digitalisation. However, oncology faces challenges due to complex methodologies, unstructured content, and diverse patient characteristics, which can burden the review and assessment processes, impacting regulatory approval. To address these challenges, Clinical electronic Structured Harmonised Protocol (CeSHarP) M11 guidelines have been proposed. This paper explores the specific nuances of adopting these guidelines in oncology.

METHODS: The International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) M11 draft guideline on CeSHarP was released in 2018 and further modified in September 2022. Using the clinical protocol template and technical specifications delineated in these guidelines and publicly available digital templates, several protocol sections can be digitalised. We practised and reviewed such digitalisation within the oncology context and developed an action roadmap adhering to M11 guidelines compatible with evidentiary needs for accelerated approvals in oncology.

RESULTS: Oncology-specific adoption of M11 guidelines effectively addresses complexities arising from intricate methodologies, unstructured content, and varied patient characteristics. Accelerated assessment-focused protocol digitalisation demonstrated the flexible nature of the digital framework—a key strength of the M11 template—by allowing researchers to populate fit-for-purpose evidence only. It also facilitated collaborative protocol review, ensuring continual updates in a seamless manner. However, due to variable inter-author approaches to dealing with the M11 template, we identified a scope for further standardisation with clearer instructions tailored for accelerated approvals.

CONCLUSIONS: Although adopting CeSHarP M11 guidelines in the oncology context can offer substantial benefits for swift, high-quality protocol development for accelerated approvals, challenges such as resistance to change and the need for a regulatory-compliant, secure IT framework remain unaddressed. For effective adoption, cross-functional training between medical writing and digital technology professionals, thought-provoking initiatives such as digital hackathons, and strategic partnerships between regulatory bodies, industry, and academia are recommended.