You may already know that with their writing, regulatory Medical Writers enable decisions that support the development of safe and effective therapies for patients. This is why we write.
What we do to support the development of safe and effective therapies for patients is to write regulatory documents. Each and every one of the documents we write has its own purpose, timing, audience and lifecycle. They are required at specific timepoints of the drug development process, have their own structure, audience and language style. All together, they tell the story of a drug, from its discovery to its marketing authorisation.
In some way, regulatory Medical Writers are storytellers. It is our job to tell a clear, coherent and concise story that informs the reader.
The story goes like this:
Medical Writers write the story of the plan to discover if a drug can safely and effectively help patients improve their health. This plan is known as a Clinical Study Protocol (CSP). And like all plans, circumstances can dictate changes to that plan, which are recorded as Protocol Amendments, also written by Medical Writers.
The plan is then shared with a potential clinical trial participant in an Informed Consent Form (ICF), which is also where they are asked whether they are willing to be part of the trial or not.
Once a study ends, Medical Writers write what the study team found (was the drug effective in treating the intended disease?) and how this affected the participant (did the drug cause any side effects?). This part of the story is called a Clinical Study Report (CSR).
Each trial in each phase has its own CSP, ICF, Protocol Amendments and CSR, and all together are the Clinical Study Documents.
The more trials that are run, the more we know about a drug's effect. How these trials went and what were the results is written in a document called the Investigator's Brochure, which tells the story from the first to the last trial in which a drug was used.
Clinical Study Documents are rarely read from start to finish in a linear fashion, so Medical Writers write a Clinical Overview and Clinical Summary of what was done and found during the clinical stage of the drug development.
From the beginning, the story of a drug is conceived to help patients in the real world, so to let them know what the drug does and how to use it safely and effectively to treat their symptoms or cure their disease, Medical Writers write the Package Leaflet.
Before the drug is made available to patients, the company that has developed it needs permission from government agencies.
To get this permission, the nonclinical and the clinical stories (Phase I to Phase III CSPs, ICFs and CSRs ), their short versions (Nonclinical and Clinical Overview and Summary), and the information the patient would receive (Package Leaflet) (plus other documents not mentioned in this post or not written by Medical Writers), are put together to create the Common Technical Document (CTD), which is then sent to the regulatory agencies.
The agencies will read the story of this drug and if it is clear, consistent and supported by evidence, they will allow this drug to be given to patients.
With their writing, Medical Writers support the drug development process and help patients receive the medicines they need.
There are many more documents written by Medical Writers than the ones mentioned in this post, but the Clinical Study Protocol, Protocol Amendments, Informed Consent Form, Clinical Study Report, Investigator's Brochure, Clinical Overviews and Summaries and the Package Leaflet will be the first ones, if not the most important ones, that you will have experience with as a Medical Writer. Together, they will tell the story of a drug to your main audience —physicians, patients and regulators— and is your responsibility as a Medical Writer that that story makes sense to all.
