Optimizing Your Chances of Approval: How to achieve effective regulatory documents


Writing for Decision-Making

Regulatory documents submitted to health authorities are business critical. Yet, 9 in 10 regulatory reviewers say poor document quality impedes their ability to provide regulatory assessment. Why is that? And how can you avoid these pitfalls and optimize your chances of approval? These are some of the questions this white paper addresses.

Writing with purpose
The aim of submitting regulatory documents is ultimately to get an approval – to run a trial or to get marketing authorization for a drug, for example. As such, each document type has a specific purpose. This could be to describe a clinical trial in a protocol, report results in a clinical trial report or to reply to regulatory authorities in a response document. What these documents have in common though, is that they are being submitted for decision-making.
Writing for decision-making is increasingly important, as the submission process is often a lengthy and costly process due to the volume and pace of regulatory processes. Yet, authors often fail to meet document quality standards.

Document quality affects reviewers
Poor document quality affects as many as 9 in 10 regulatory reviewers.1 They say this impedes their ability to perform regulatory assessment. Additionally, 80% of the applications that are ultimately approved are delayed due to poor document quality.
These numbers are striking and the consequences critical. Needless to say, the development of new medicines is a costly process and once reaching a potential marketing approval, every single day counts. Secondly and importantly, this could cause delays in the availability of promising and sometimes lifesaving new drugs or medical devices to the patients.2,3

Pitfalls that affect reviews negatively

Poor explanation of rationale. Excessive length. Incomplete content. These are issues that negatively affect regulatory reviewers, according to a recent American Medical Writers Association (AMWA) study.1

Reviewers read in a specific way
A general understanding about regulatory reviewers is that they have limited time to assess your document and that they read in a specific way.
Therefore, document quality plays an important role for the reviewers’ ability to assess documents.

Document quality impacts assessment
Poor explanation of rationale, excessive length and incomplete content are the most frequently encountered issues related to document quality and the issues that cause the reviewers most irritation. Hence, these are problems that anyone developing drugs or devices would be interested in overcoming. But do they also impact the timelines for and chances of application approval? The short answer is YES.

Particularly, poor explanation of the rationale is a key concern for the reviewers and the one with the greatest negative effect on application approval (refer to figure below). Some regulators share that they interpret a poorly written rationale as lack of transparency, which could call the entire application into question. Consequently, documents with poorly written rationales would likely be flagged for additional investigations thereby prolonging the review timelines and ultimately impacting the changes of approval negatively. Therefore, clear strategic presentation of relevant rationales supported by data should be a top area of focus for the teams responsible for documents submitted to regulatory agencies.

Poor explanation of rationale has the greatest negative effect of application approval.1

5 keys to ease decision-making

Reviewers base their decisions on their understanding of the data. Therefore, it is key that a high-quality document transmits the necessary information clearly, transparently, and accurately. So, how do you build a document that aids the reader’s processing of data, interpretations, and conclusion? And how do you make information understandable?

A strategic medical writer understands how to serve the target reader’s need. They understand not only how to build a compliant, concise, and clear document, tailored to the document purpose and for decision-making, but also how to guide the reviewer to understand the author´s logic, interpretation, and conclusion.

Medical writers unfold the story emerging from the data. They interpret these data together with a team of experts and map out the steps for the reader. This way, the writer builds a story with clear messages, ensuring a logical flow to explain how the different pieces of information relate to each other. As a result, this guides the reader through the sponsor’s flow of thought and maps out how they arrived at the conclusions. This is at the heart of effective medical writing and draws on three essential skills to be successful.

How a strategic medical writer can spearhead your way to approval

3 Essential skills needed

  1. Lead cross-functional teams – Medical writers facilitate progress in the development of the document by building strong relationships with members of a cross-functional team. It´s common for writers to act as negotiators and facilitators, and writers are especially skilled in helping team members align on document messaging. This is because they understand the project vision and the road-mapping for how drugs move through clinical trials. They keep the overview of the messaging as well as how the message applies later in the process. How will pieces of information in the protocol play in the clinical trial report? And how will it ultimately support what you want to defend in the label? The writers’ insight and foresight lead to the second key skill of a strategic medical writer.
  2. Advise on strategy, guidelines, and regulations – Medical writers safeguard the aim, legacy knowledge, and guidelines and regulations. They can explain what information goes where, along with why and how the sections relate to each other. Our team of experienced medical writers find that projects, more often than not, need someone who can advise on a strategy that is aligned with past documents and compliant with guidelines. And someone who knows how to structure the document to make it user-friendly. Experienced medical writers know this. In addition, they can help distinguish between best practice and formal regulatory requirements to ensure clarity and readability. Consequently, they enable the document to be the tool it is intended for – for reviewers to base their decision on.
  3. Ensure strategic authoring – Each document has a specific purpose targeted for a specific reader – and each document is reviewed by specific bodies. This means each document may need a different writing style or use of language, and that they may need a different approach to present information for usability and review-friendliness. Medical writers help the regulatory reader to navigate the complex subject matter of your document. Effective, experienced writers clearly map the direction of arguments and conclusions for their reader, by consciously guiding the reader through the document. Explicit signals, such as connecting sentences or providing visual clues, and a logical trail aid the reader’s understanding and processing of data, interpretations, or conclusions. Consequently, the document mapping affects the degree of recognition and emphasis the reader gives to pieces of information presented.

The content of each document is highly specialized and often covers many functions which require a variety of competencies, such as a scientific understanding from various therapeutic areas, non-clinical and clinical experience, communication skills and adherence to guidelines. Also, good project and stakeholder management skills contribute by bringing together competencies across a company to meet the purpose of a regulatory document. To capture these competencies, three key attributes signify a skilled medical writer.

Join forces with a medical writer

As you can see, medical writers spearhead the writing process in that they guide cross-functional teams, ensure a document strategy and build a well-structured document to focus the reader’s attention and aid their understanding and interpretation. In addition, they design elements for readability. Together, this benefits an efficient drug development process. And it benefits the reviewer’s ability to assess the document.

Thus, a strategic and experienced medical writer supports the development process so they can trust the document is compliant, concise, and clear, and thereby meets the expectations a reviewer has on quality and decision-making.

Learn how the Aixial Medical Writing team can support your needs
With the understanding of how document quality can impact your next product’s success, a medical writer may very well become your new best friend. But where do you find one?

Many CROs, including Aixial Group, have dedicated medical writing departments offering specialized medical writing services. Our team of expert medical writers offer support within a complete range of regulatory documents as well as scientific publications. With an average of 10+ years of direct medical writing experience (and many more when counting the total pre-clinical and clinical research experience), our team brings extensive experience and a proven track record to the table. We take pride in developing high quality, regulatory compliant documents to deadline that can open the doors to the future success of your project.

It is never too early to start planning your clinical trial documents. Many hurdles can be overcome through timely planning, and the earlier we’re involved the easier it will be for us help you. We welcome formal project proposals as well as informal interactions to explore ideas for how we may be able to help.

Reach out today to info@aixial.com to learn how we can add value to your project.

1Cooper J, Chamberlain J, Affleck J, et al. Value of medical writing: the regulator’s perspective. AMWA Journal. 2021;(V36N4):145-51.

2Kola, I., Landis, J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 3, 711–716 (2004). https://doi.org/10.1038/nrd1470

3Eichler, HG., Pignatti, F., Flamion, B. et al. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat Rev Drug Discov 7, 818–826 (2008). https://doi.org/10.1038/nrd2664

Other insightful resources

Let’s support you on your next project