Case Report: Manuscript Writing
Client
- Biotherapy pharma company, Global, UK and US Clinical Development teams
Challenge
- Submit and publish pivotal trial data in a high impact factor journal (New England Journal of Medicine [NEJM]) on a very tight timeline.
- Provide strategic guidance to the client regarding journal expectations, Good Publication Practice (GPP) guidelines, and reporting requirements for clinical trials.
- Liaising with a very large author group (38 authors).
Approach
- Using the clinical trial protocol, NEJM guidance for authors, and with reference to CONSORT requirements for reporting clinical trials, we produced a clear draft outline, and latterly produced all subsequent manuscript drafts.
- Weekly status calls were held with the Clinical Development team, where the progress of the manuscript and other elements of the submission package were discussed.
- Alchemy provided strategic guidance on reporting requirements and GPP – sometimes this required pushing back to ensure the information included complied with best practices and journal guidance, whilst maintaining the strict word limit.
- The Alchemy team also liaised directly with the large authorship group to gather all information and approvals required for the submission.
- Once all review rounds were complete, approvals received and tracked, and all author forms completed, the Alchemy team pressed ‘go’ on the submission.
- We then liaised with key stakeholders to draft appropriate responses to peer-review and editor comments.
- Finally, once the proof document was received, a full check was made vs the submitted manuscript to ensure no editorial changes affected the data or intended messaging.
Result
- An exceptionally high-quality manuscript was submitted to the NEJM.
- We were able to satisfactorily address all editor and peer-review comments, and the manuscript was accepted and published.
Lesley and Adam are two of the best medical writers I’ve ever worked with.
