Minimal Time and Effort Should be Applied to the Creation of the Clinical Study Report Synopsis

How much time and effort to apply to the creation of the clinical study report synopsis?


This is another question I am asked on a regular basis and a line of discussion that repeatedly comes up when I am working with clients to help streamline work practices. I usually draw slack jaws accompanied by an incredulous stare as I give my answer: 


"The amount of time should be minimal, involve no more than three people, the level of effort better be next to nothing, and the time should be no more than an hour to create and a whole lot less time to review."


My reasoning is very simple and straightforward.........."You apply time and effort to the development of a product in relationship to the product's strategic value. The value of the CSR Synopsis to the regulatory reader is virtually zero."


Think about it. The CSR Synopsis affords little utility to what the reviewers are looking to accomplish when they choose to enter the framework (that is, the document) of an individual clinical study. If a regulatory reviewer wants a “snapshot” of a study, they will likely take a contextualized snapshot at a higher level of a drug submission dossier. That is, the documents in Module 2. They do not enter the framework of the study report to get generalized or summarized information. They are at the Module 5 level and embedding themselves in a clinical study report because they are seeking answers to narrowly defined questions.


At McCulley/Cuppan we have queried regulatory reviewers about how they "use" a study report synopsis. Their responses support the premise I have laid out for you in the above paragraph.


So this gets us back to the question on time and effort. Why generate a study report synopsis with every draft? Why allow the full team to look at the document? Talk about wasting time and energy. 


In our assessment of review practices at pharmaceutical and medical device companies we see the same review pattern played out time and time again. The study report synopsis is generated with the first draft and in the review process it consistently garners the attention of the full review team (many of whom never make it all the way through the results sections during the course of their reviews.) Same thing happens on each subsequent draft.


Given the synopsis is but a summary of the body of work presented in the study report, it should not be generated until that body of work is completed and signed off as "good to go." The synopsis does not even warrant review. It should be critiqued. Critique is a comparative read. A reading to ensure that the synopsis accurately and appropriately portrays the sum total of key details of the study. The critique process requires at best two people and certainly no more than three. All being subject matter experts drawn from the key clinical disciplines represented in the research study.