In the wake of the 21st Century Cures Act (December 2016), the FDA has switched gears to accelerate the development of novel therapies and speed up the review process, particularly in the field of cancer research and treatment with the Oncology Center of Excellence. These efforts are the result of growing concerns over the progression of the disease.
How does that impact oncology medical writing? Beyond the urgency to make progress in research and develop new programs, studies are becoming more complex making data analyses and writing of these analyses more intricate. Digitalization has transformed the way people consume content and regulatory guidelines continue to evolve (promotional and educational material included), prompting organizations to hire writers with specific skillsets or turn to external experts.
Considering the amount of content pharmaceuticals and biotechs must produce, adopting best medical writing practices is crucial to ensure that documents are understood and interpreted without ambiguity, especially in this litigious age.
Oncology Medical Writing Tips
Treximo has provided medical writing expertise in many therapeutic areas for years these are the seven tips that we’ve found that are the most helpful when writing for oncology and other diseases.
1. Acquire Oncology Knowledge
Understanding the fundamentals of the field – chemistry, pharmacology, toxicology – is a significant advantage. When compiling the data, this knowledge will help create a coherent document and prevent misinterpretation or misrepresentation of findings. This is especially true in oncology where new targeted therapies are always emerging. For example, FDA’s Precision Medicine Initiative outlines new approaches to regulate genomic technologies. Becoming familiar with these standards increases the chances of producing an accurate summary of the study.
2. Master Ethical Standards
Oncology medical writing faces ethical issues that are not as acute in other therapeutic fields. Patients in oncology trials, for instance, cannot be given a placebo. Summarizing experts’ opinions could also be a minefield if the writer is not familiar with potential controversies. One sure way to avoid any pitfall is to adopt strict ethical guidelines crafted from existing standards, internal reviews and discussions with peers.
3. Take Good Care of the Data
The digital age forces us to revisit how we work. Everything is now electronically stored, with various levels of accessibility. Medical writers should consider the best ways to protect data accuracy and integrity and cooperate with team members to ensure regular backups and safety protocols. Cybercriminals are quite crafty, especially when the opportunity of obtaining critical data arises.
4. Develop Interpersonal Skills
If a medical writer isn’t a natural leader, they could quickly get overwhelmed by the dynamics of a multidisciplinary team. Since they are tasked with gathering and creating a narrative with datasets from many sources, writers should establish themselves as the master communicator. Communication between all stakeholders is the key to minimizing the risks of failure, be it a refusal from the FDA or a study that never gets published for lack of weight. Have open dialogues and discussions to smooth out conflicts, eliminate uncertainties, and clarify facts when necessary.
5. Become a Project Manager
Many people may be involved in the project, but the team of medical writers is often under more pressure. As a project manager and medical writer, your role is to unify and federate around workflows and set expectations. Internal deadlines are often pushed for a variety of reasons, but the project’s due date cannot be extended so freely. Medical writers can own the project by assigning tasks, setting up a meeting calendar (for reviews, Q&A), enforcing due dates, and planning for technical emergencies. An efficient project management office design can help facilitate this process.
6. Polish the Design
Medical writing tips always discuss impeccable grammar and spelling. What is often missing from the list is the importance of design. Establish templates for each type of document, from content organization to dataset size and definition, bookmarks, hyperlinks and formatting checklists. Another aspect to consider is the use of different content forms. Are written words the best way to convey your intention, or would graphics or videos be more impactful? Understanding your audience can help you answer questions like these.
7. Increase Clarity, Decrease Noise
Documents should be easy to read and designed for each audience. Chatter and fluff have no place in medical writing. Too often, authors feel their paper is too short, which could be perceived as if they have nothing to say. Don’t drown facts with too many qualifiers or overcomplicated syntax. Pay attention to paragraph breaks to keep a cohesive flow. Be precise and concise.
The Future of Oncology Medical Writing
Medical writers are the voice that crafts research findings into a data-driven narrative meant to educate, promote and guide.
With the emergence of precision medicine, writers in the oncology field will need to continuously sharpen their skills, stay up-to-date with fast-paced breakthroughs, and train for the race against time.
Treximo’s medical writing services are not one-size-fits-all. Each writing project is unique and combines the experience of many industry experts to deliver the content that fits your objectives and your audience.