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10 BioPharm International ® Quality and Regulatory Sourcebook eBook March 2024 www.biopharminternational.com Risk Management • knowing when subjectivity might exist • knowing what to do about it when it does. In the opinion of the authors, creating a common understanding of subjectivity is a prerequisite for both of these challenges and is an important need for the industry and those involved in the practice of QRM, as discussed in the next section. Subjectivity: seeking a common understanding While high levels of subjectivity were identified as an issue, it is notable that neither ICH Q9 (2), the ICH Q9(R1) Concept Paper (1), nor ICH Q9(R1) (8) provide a defini- tion for subjectivity. In the opinion of the authors of this paper, this lack of a common operational definition and/ or associated examples poses the risk of an inconsistent comprehension and understanding of what subjectivity is. Therefore, establishing a common definition of sub- jectivity as it pertains to QRM is important. Basic definitions of the word subjectivity exist, in- cluding the following dictionary entries: • "The qua lit y of being based on or inf luenced by personal feelings, tastes, or opinions" (Cam- bridge Dictionary) • "The inf luence of personal beliefs or feelings, rather than facts" (Oxford Dictionary). While these definitions certainly provide a good starting point, the world of QRM has many different challenges, including: • leading-edge science and new types of therapies • expectations for speed (e.g., product development in response to a pandemic or other market pres- sures) • human behaviors (e.g., expert opinion, heuris- tics, bias) • multi-step QRM process with many different par- ticipants over a long-time horizon. It is difficult to recognize when subjectivity enters QRM and inf luences outputs that may affect product quality and patient outcomes. The authors suggest this is an important topic for future study. Notwith- standing, the lack of a definition for subjectivity ICH Q9(R1) does offer important clues by its use of other language, in particular language that evokes objec- tivity as the antidote for subjectivity in a scientific setting, as explored in next section. Subjectivity: a closer examination of its emergence in ICH Q9(R1) While ICH Q9(R1) (8) does not expressly define sub- jectivity, an examination of it in comparison to the 2005 version of ICH Q9 (2) reveals the emergence of the term subjectivity, which appears 10 times in the revised document in contrast to the lack of being mentioned in the original. Furthermore, the authors have observed that the language in ICH Q9(R1) includes concepts related to subjectivity- and objectivity as its antonym, for ex- ample: • synonyms for subjectivity (e.g., bias) • terms which invoke scientific facts which sug- gests minimizing subjectivit y (e.g., evidence, data, information, knowledge) • k nowledge ma nagement (K M) as a mea ns to manage and deliver scientific knowledge to QRM and risk-based decision-making processes. A simple comparison of the two documents was conducted by the authors to evaluate the frequency of relevant terms in each ICH Q9 and ICH Q9(R1), the results are presented in Table I. As can be seen by the comparison, there is a sig- nificant increase in subjectivity related concepts in ICH Q9(R1). The authors believe this signifies a pro- active desire to address subjectivity. By incorporating these related concepts, the revised guideline empha- sizes the importance of basing risk assessments on objective evidence and data-driven insights. This shift toward more objective decision-making that is evidence-based, while seeking to minimize the in- Table I: Frequency of subjectivity-related terms in International Council for Harmonisation (ICH) Q9(R1) and ICH Q9. KM is knowledge management. Frequency of Terms Q9 (2005) Q9(R1) (2023) difference Subjectivity-related terms subjectivity 0 10 +10 bias 0 2 +2 Terms invoking scientific facts (to minimize subjectivity) evidence 1 2 +1 data 8 11 +3 information 22 24 +2 knowledge 10 27 +17 KM as a means to manage and deliver scientic knowledge KM 0 4 +4