Christine Quagan, Senior Medical Writer, PROMETRIKA, LLC
Recent articles in Medical Writing, the Journal of the European Medical Writers Association, recommend collaboration between medical writers and biostatisticians. Authors from one Russian CRO even consider medical writers and biostatisticians to be “best friends forever”!1 This friendship thrives on communication and collaboration.2
With over a decade of collaboration, PROMETRIKA’s medical writers and biostatisticians exemplify the “best friends” described in the articles. An open line of communication is the foundation for the collaboration, enhanced by aligned standard operating procedures (SOPs). The medical writer and biostatistician can then develop a unified approach to meeting industry best practices, including agreeing on templates and style guides, timelines, and level of review required for each draft document.
Medical writers and biostatisticians at PROMETRIKA work together to ensure the consistent expression of the study design, objectives, and endpoints in the study protocol, statistical analysis plan (SAP), or clinical study report (CSR). During this collaboration, the medical writer and biostatistician can readily answer each other’s questions and discuss issues that arise during study conduct and document review. For example, the biostatistician can inform the medical writer of protocol deviations and randomization issues, and the medical writer can alert the biostatistician to sponsor comments that request new statistical analyses.
Ready access to in-house biostatisticians gives PROMETRIKA’s medical writers an advantage that freelance writers do not have. For example, a freelance writer recently posted a request for assistance with interpretation of statistical analyses on an internet message board. The writer was still waiting for an answer two months later!
PROMETRIKA’s medical writers can get answers to such questions in just minutes. A medical writer recently had a question about the effect of covariates, such as patients’ medical history or other background, on an outcome. Which covariates affected the outcome? After a quick consultation with the biostatistician, the medical writer not only understood which covariates affected the outcome, but how this result was consistent with other analyses in the study. PROMETRIKA’s culture of collaboration between medical writers and biostatisticians leads to clear and accurate clinical documentation. For the benefit of sponsors, and the patients they hope to help, our team will remain “best friends” for a long time.
- Radkova, E and Dobromyslov, I. Best friends forever: A pattern of collaboration between medical writers and biostatisticians in the Russian CRO. Medical Writing 2016;25(3):46-49.
- Miller, S and Billiones, R. Biostatistics and medical writing: Synergy in preparing clinical trials documents. Medical Writing 2016;25(3):43-45.