Designing Regulatory Submission Documents for Decision Making

I have made blog posts from time to time talking about users of various document genre represented in communication about life science research. I believe that for many, my portrayal of how people engage with documents presents a different picture than what they hold in their imagination. At least I hope it is the case that they are designing documents to a meaningful mental model, as that helps to explain why so many documents I examine are rather ineffectual communication vehicles. Unfortunately I believe most documents are generated according to the model of precedence--"what did we do last time?" I think this is generally the only question consistently asked in the life sciences regarding document design.

In this post I want to talk about designing documents to satisfy readers who must make decisions, like a regulatory health agency reviewer. These reviewers must decide whether a drug, biologic, or device can be marketed as desired by the sponsoring company.

There is nice body of work in the cognitive sciences that describes the mind set and reading style of the selective professional reader who is reading documents in order to make a decision or a set of decisions. It is clear from this research that these readers are not empty cups waiting to be filled up with whatever you want to send their way in your documents. Not only is the professional reader very selective in what they will read, they are also very critical. That is, they read against the information you have submitted in your documents looking for insufficiencies and weaknesses.

Remember that the selective professional reader working in the the health regulatory agencies is a very sophisticated reader and in many instances they know what type of information they need right after they review the requested marketing claims for the drug or the medical device.

Here is the part that many people miss in creating their documents. No matter how logical and detailed your information may be, if you have not correctly anticipated what the selective professional reader needs in terms of information and the necessary level of detail, then you have failed. It is that simple.

Research shows clearly that decision-making is a function of schema-based cognitive processes deployed by the selective professional reader. The process is really well understood now and suggests that all documents  to be used in a decision-making environment should be designed to support a schema-based reading style versus the approach of reporting information or summarizing findings.

Schema activation is at the heart of decision making. Schema provide the interpretive framework for a reader to pass judgement on data and written discourse. In the process of reviewing drug and device submissions, the selective professional regulatory reader will make use of many, many schemata during the course of the decision-making process. Each schema they deploy will have multiple slots for information. They will want to fill every slot and they search documents and data bases looking for the details associated with the various slots in a particular schema. For example, a specific schema can be characterized by this question: "will the indicated drug dose lead to an undesirable toxicity profile in the elder, under weight, and hepatically compromised patient?" They will then examine the documents presented to find all the information they desire in making the decision whether the drug label language regarding dosing is acceptable or needs to be modified. And they read only looking for what they believe are the necessary details. In essence, they read at the virtual exclusion of anything within the document(s).

This is why we talk about  the selective professional reader scanning documents looking for very specific information and now using some sophisticated search tools to navigate through documents looking for specific pieces of information and data.

Much of what the selective professional reader at regulatory agencies do is further characterized as an attribute-based search. The attributes are often compared against known standards, but may also be subjective standards. The attributes they are considering are largely tied into the product label claims the sponsor wants to make.

So the net-net here is that life science research professionals need to reconsider what they believe to be acceptable document design parameters. It is essential to build out effective working models for how the selective professional reader using your documents makes decisions and what schemata are being deployed in this process and then design documents that support these specific reading methods.