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How to streamline a complex process: why experienced medical writers will add value to oncology dossiers
, senior partner, and , senior medical writing manager at Trilogy Writing & Consulting, discuss how medical writers can smooth the process of producing oncology dossiers.
O
https://blog.navitus.com/specialty- pipeline-2021 Cancer is a disease that is frequently treated
over the long term, and even when the cancer has been eliminated, follow-up continues for years. As a result, the end points to assess efficacy tend to look at the effect over time and its endurance, not just a static assessment of whether the disease is cured, as in many other therapeutic areas. The challenges associated with this in the context of submission dossiers arise from the fact that there are often multiple interim study reports, in addition to the final CSR (clinical study report), and multiple data cuts over time (sometimes with different data cuts across multiple studies, which can be tricky to explain to the reader of a submission). Cancer therapy is also a dynamic area, with
developments in biotechnology rapidly shifting the approach to treatment. The medical dogma in many cancer types can shift swiftly, which means that the scientific rationale, available treatments, and medical need descriptions must often be updated frequently – sometimes changing considerably, even within a 12-month period, as new treatment options alter the therapeutic landscape. The role of the medical writer in the dossier- writing process is to collaborate with the clinical experts to understand their vision for the treatment being studied and to crystallise the messaging from the clinical programme. The medical writers need to come to terms with the oncology-specific terminology, acronyms and efficacy endpoints (progression-free survival, overall response rate, duration of response). They also need to work with the clinical teams to know where current changes in the medical opinion might need to be reflected in the medical need discussion and to understand how the product under assessment needs to be positioned in the overall picture of available therapies. Frequently, because the clinical experts are often deeply involved in the research going on in their area, the medical writers need to help the experts step back from the minutiae and look at the big picture in the context of a registration dossier. It is important that the regulatory documents stay focused on what is needed to get regulatory approval of the target product profile (TPP) and not get off target and bogged down by academic questions (that can be interesting but should be saved for publications).
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