The document brief
A document brief establishes what is to be written, what it should achieve, who will read it and what evidence and instructions will guide the work. Clarifying those decisions before drafting reduces the risk of pursuing an assignment whose scope or intended outcome remains uncertain.
Scope and outcome
Medical and scientific writing transfers information to a person or group to achieve a specific outcome. Three examples pair a document with its intended outcome.
- Nonclinical data presented to FDA regulatory professionals to argue that the safety and efficacy findings warrant approval of a single ascending-dose protocol in humans.
- An abbreviated report from a first-in-human study recommending that the company's management discontinue development of a compound previously expected to be a blockbuster.
- A manuscript presenting important new scientific data, intended for acceptance in a reputable journal and wide reading by the target audience.
A planning framework brings together science, guidelines, language and tools, with strategy directed towards the target audience, key messages and desired outcome. Assuming solid data, the chances of success depend on how those elements are managed.
A six-field planning template helps establish a logical train of thought and cover the important issues.
| Field | Planning decision |
|---|---|
| Document | Identify the document type, such as a study report, investigator's brochure or publication manuscript. |
| Outcome | State the optimal desired outcome, such as acceptance in an appropriate journal that will influence cardiologists' prescribing patterns. |
| Guidelines | Identify and consult the appropriate guideline, such as FDA guidance on investigator's brochures. |
| Target audience | Identify the readers and consider their background; informed-consent information for trial participants should use language lay people understand. |
| Key messages | Identify messages grounded in solid scientific or medical knowledge that convey information to decision makers and achieve the desired response, such as approval of a pivotal trial protocol. |
| Information sources | Identify supporting data from the literature and previous work by the sponsor. |
The same template can support an oral presentation and its accompanying visuals.
A complementary first-step checklist asks five questions.
- Why is the message to be communicated?
- What is to be communicated?
- What is to be shown?
- What is the purpose of the text?
- To whom is it to be communicated?
Clarification before work begins
Questions about what an assignment includes or how a service is to be performed should be asked before work begins. Otherwise, time spent trying to understand the brief later may be wasted and may not be paid for.
For a journal manuscript, the initial details should include timelines, the writer's responsibilities, team members and ultimate publication goals. Defining tasks, setting priorities and preparing a tentative schedule can avoid common problems during writing and revision. Obtaining stakeholder agreement at the start can avoid revision delays caused by late reviewer input.
Evidence, instructions and document status
In drug development and pharmaceutical medicine, key messages should rest on solid, well-presented data, supported by thorough review of the literature and available nonclinical and clinical data from the development programme. Supporting information can come from published literature or in-house research, and the writer should be thoroughly familiar with the data underlying the argument or proposal.
Applicable instructions may include internal company guidelines, regulatory guidance and journal instructions for authors; they should be consulted before writing begins. Following them closely is advisable because they reflect readers' expectations. Where a guideline does not fit the issue, any departure should be made clear upfront and justified, adding value, clarifying the key message and improving the chance of a successful outcome.
Planning should also establish whether the document is final, such as a final study report, or living, such as an investigator's brochure that changes as new information becomes available.
Planning practice
One exercise develops planning templates for four assignments.
- A scientific publication: a company has developed a novel antihypertensive drug and submitted its Common Technical Document. General practitioners are the target prescribers, first-line use is the desired position, and data from two pivotal studies in mild to moderate essential hypertension are available. The exercise is to plan a publication complementing the marketing campaign, imagining a target profile.
- An investigator's brochure.
- A study protocol.
- A study report.
The exercise retains the first templates while reading Strategic Scientific and Medical Writing, repeats the planning after finishing the book without looking at the first set, and compares the two sets.