Here are some generalizations about regulatory readers and corresponding document design actions:
- Regulatory readers work under a spotlight, in agencies subject to governmental scrutiny, with high levels of public criticism. Therefore it is important to write discussions to bring in focus the troublesome study issues of the development program. Highlight the issues as questions the regulators are likely to ask and provide responses to the questions, appropriate rationales for the responses, and then explicitly point to the corresponding data that underlies or supports your response.
- Regulatory readers may be in the same broad field as the industry scientists who developed the drug or device, but they likely will not have the same level of specialization. Therefore, explain key decisions regarding development programs, study designs and methods of analysis. It is important to provide scientific and regulatory context to help support scientific expectations and reasoning.
- Each regulatory reader brings specialized expertise to a team evaluation, where multiple reviewers work with different sections of the marketing request application for a drug or a device and arrive at various perspectives on the filing. Therefore authors must assume global use of their documents with multiple readers taking multiple perspectives. Authors must provide entry context at the beginning of main sections. That is, orient readers with purpose and main messages at the beginning of sections.
- Regulatory readers are swimming in a sea of documentation. Make it easy for them to navigate your document. Carefully consider how discussions will be sequenced within sections and across sections of the reports as well as summary documents. Assume your regulatory reader applies a coordinate review to your document. Design pages for easy skimming and scanning. Use informative headers and deep subsection structuring.
- Each regulatory reader has individual ways of working—individualized practices, work habits, and standards that have evolved as they have become expert reviewers. A common point is that they all read “against the text” by looking for weaknesses in the conduct of science, logic of arguments, and unsupported positions. This means authors must be aware that the regulatory reader is largely looking for what is not there in the document. It is therefore important to design documents assuming multiple points of entry for the reader. Critical information may need to be summarized in several locations to ensure the reader does not miss critical arguments. Repetition of information must be carefully managed so as not to become redundant.
Originally published on our Knowledge Management blog
Below is a reposting of the comments we received on the original posting of this piece:
ReplyDelete4 Responses to Designing Documents for the Regulatory Reader
1. Catherine Hibbard says:
February 4, 2010 at 11:21 am
Thank you for writing this article. I now plan to include a link to this posting in my instructional materials for technical writing and policy and procedure writing training when the participants write for a regulatory audience. I also plan to publicize it with social media to call attention to your work.
2. gcuppan says:
February 4, 2010 at 3:31 pm
Catherine: thank you for the comment and the effort to bring attention to our work.
3. Sean Patterson says:
February 10, 2010 at 9:48 am
I’ve worked for several global pharma companies and all took an extremely conservative approach to scientific argument that could be summarized as follows:
1. Let the data make the argument, not the text.
2. Don’t include any statements that could be considered advocacy.
3. Avoid ‘pro’ phrases such as ‘shows that’, ‘highly significant’, ‘clinically significant’, or any ‘anti’ phrases such as ‘lack of efficacy’, ‘teratogenic in animals’, etc.
So the industry-wide approach is that it is FDA’s job to judge the safety/efficacy of a product. It is the company’s job to provide all data and to highlight data that suggest the decision wished for, but not to make any significant argument in that direction other than that the product is ‘appears to be generally effective and tolerable for the indicated use’.
4. gcuppan says:
February 10, 2010 at 10:08 am
Sean: thanks for the well-framed comment. Yes I concur with your position that the prevalent approach for many pharmaceutical companies is to “let the data make the argument.” Unfortunately most data generated in pharmaceutical development is at best equivocal and at worst multivocal. That is, the data are always subject to alternative interpretations. Thus, this equivocacy for interpretation of meaning or significance then encourages the need for drug sponsors to assign their position in writing.
In the course of our many interviews with drug regulators at the FDA and in Europe, it was the exception NOT the norm to expect documents written per the three tenets you mention. No regulator will favor submission documents that make bold-faced claims or are loaded with the overburden of advocacy. But they do want the sponsor’s arguments as to how the data line up to defend the proposed label.