key: cord-0773099-ulk9ar8n authors: Daizadeh, Iraj title: Since the Mid-2010s FDA Drug and Biologic Guidelines have been Growing at a Faster Clip than Prior Years: Is it Time to Analyze Their Effectiveness? date: 2020-10-22 journal: Ther Innov Regul Sci DOI: 10.1007/s43441-020-00233-0 sha: f119a25be76f87006bc63ae392ebe689b75fcd2a doc_id: 773099 cord_uid: ulk9ar8n nan pre-COVID-19 guidelines covered an assortment of disease, platform and/or conduct of certain DDDD activities. Albeit efforts have been underway to empirically test if guidelines facilitate approval of medicines, it is challenging to use statistical tests to ascertain true causality between the two (see [1] ). Anecdotal evidence appearing in the literature suggest the importance of guidelines to the DDDD process. While there are reports critical of these guidelines (see, e.g., [12, 13] ), and those advocating an opportunity for collaboration between developers and the FDA (see, e.g., [14] ), there are examples of general successes in clarifying forward pathways (see, e.g., [15] [16] [17] ). In some cases, there are explicit calls for guidelines; e.g., on endpoint selection for cancer cachexia [18, 19] , or performing studies in cancer in the geriatric population [20] . Given the general interest and importance to the DDDD process, it is surprising that-to the author's knowledgethere has not been a robust investigation detailing the effectiveness of the guidelines. For example, from a data economization perspective wherein a multipronged approach would be to think about a given guideline in terms of its ability for abstraction (how general is the concept?), for codification (how explicit can the text be (see, e.g., [21] ), and for diffusion (is the guideline sufficient to convey all the important aspects of a topic) (see, e.g., [22] ). Any effectiveness analysis should seek to also elucidate objective optimization parameters to optimize readability and understandability. Beyond a general scientometric approach, there are several other avenues of research inquiry, such as: The increase in the number of FDA guidelines has been most welcome as they provide an avenue to clarify Agency thinking on a given topic (specifically, the COVID-19 crisis). Additional work needs to be done to identify variables that may attest to its effectiveness and increase their utility for readers. It is only through mutual understanding that sponsors and global health authorities may expedite the DDDD process for the sake of patients everywhere; optimal drafting of guidelines is a critical component of the process. The author is an employee of Takeda Pharmaceuticals; however, this work was completed independently of his employment. The views expressed in this article may not represent those of Takeda Pharmaceuticals. As an Associate Editor for Therapeutic Innovation and Regulatory Science, the author was not involved in the review or decision process for this article. For data and methods to reproduce Fig. 1 , see Electronic supplementary material. The online version of this article (doi:https ://doi.org/10.1007/s4344 1-020-00233 -0) contains Electronic supplementary material, which is available to authorized users. 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