Beyond the Pen: How Regulatory Medical Writers Support Protocol Development

In my ongoing 12-Week Medical Writing Certificate Program, we spent the last 2 weeks talking about protocols. A question I posed to the group was "What do you think would be your favorite section of a protocol to write?". As expected, the answers varied quite a bit.

I responded to most of the responses to explain that medical writers may actually do very little writing during protocol development - even if they are very involved in the process. Huh?!?!

Yes, the role of the medical writer can vary WIDELY in protocol development and depend on many scenarios, including:

• The stage at which the medical writer is pulled into the project - very early (at initial concept) vs very late (after a full draft is written)

  • The level of planning that has gone into the study design - design already agreed upon vs no decisions yet made on the design

  • The stakeholders who have weighed in and been involved in planning the study - documented study design (eg, a protocol synopsis) already approved by senior leadership/other key stakeholders vs only a core team has weighed in on the design

• The tools available (eg, a good protocol template) - standard protocol template and company style guide vs no standards for protocols

• The company's infrastructure (eg, protocol development process, authoring/review platform) - protocol standard operating procedure (SOP), process, authoring/review software or SharePoint vs no standards for protocol development processes or collaborative document development

• The novelty of the investigational product and the uniqueness of the study itself - are there any other protocols from the same investigational product or protocols from other sponsors with a similar design that can be used as a model vs no relevant protocols to use as a model

All of the above can impact the capacity in which medical writers support their teams in protocol development. What we cannot do is sit down with a blank template and no guidance from our team and prepare a full protocol draft.

Medical writers are not the decision makers - especially in protocol development. We need team members with different areas of expertise to make decisions and document those decisions in the form of text (which the medical writer can help with AFTER the decisions are made). We rely on our medical and clinical development team members to make decisions on the different outcome measures best suited for study assessments (these will influence the objectives/endpoints of the study) and the population to be included (these will influence the eligibility criteria). We rely on our safety expert(s) to ensure we're properly capturing any safety signals. We rely on our biostatistician to determine how and when study data will be analyzed. We rely on many other team members (including, but not limited to, clinical operations, quality, and regulatory) to ensure the study is feasible, that it meets regulatory requirements and expectations, and that it is set up in a way that meets quality standards (eg, ICH E6).

Collectively, these team members may provide a lot of (or even most of) the text as they document their thinking and eventual decisions within the working version of the protocol itself. As the medical writer, we are still actively involved in the process and wear many hats beyond "writer".

• We are the project manager (even if there is someone with the project manager job title on the project team), ensuring that team members make decisions, provide content, and offer their expertise.

• We are the document facilitator, issuing workflows for authoring, review, QC, etc. We ensure comments are resolved and that the document improves with each draft.

• We are the editor, formatter, and consistency checker, ensuring text provided by team members is clear and concise, grammatically correct, and straightforward to execute on, that all formatting meets company standards and hyperlinking is set up properly, and that the document is consistent across sections.

• We are the communicator/enforcer of protocol standards, ensuring content does not deviate from the template being used, required and regional-appropriate language is included, and that nothing expected is missing. We also ensure that the development process follows any company SOPs.

In some scenarios, we do all of these things, but almost no writing. In other scenarios, we are provided a well-vetted protocol synopsis, a good template, and one or more relevant protocols to use as a guide, and we do a good bit of the actual writing. Your role and the hats you wear will be different with every single protocol you support.

Regardless of the amount of writing the medical writer actually does, the writer can have a major influence on both the ease of the protocol development process and the quality/robustness of the final protocol. Medical writers can do this by ensuring good communication among their team, ensuring the appropriate team members are pulled in as needed to make decisions, provide/confirm content in various sections, and raising questions/concerns as they arise. It's important when starting to work with a team on a new protocol that you understand the specific scenario(s) you are working under and put on the appropriate hat(s). By wearing the appropriate hat(s) at the right time, medical writers can add substantial value to the team and to the protocol itself.