Background: There is currently no standard definition of medical affairs, despite its increasing importance to the pharmaceutical industry. The evolution of medical affairs necessitated the development of a standardised definition to guide policy and practice to ensure that patients’ interests remain central amid shifts that have, in the past, created fertile ground for ethical violations.
Objectives: The aim of this study was to use an empirical method to observe a consensus of expert opinion on the definition of medical affairs to guide policy and practice within this function.
Methods: In total, 11 medical affairs pharmaceutical physicians (MAPPs) completed a qualitative online survey to identify a list of key items to define medical affairs using the Jandhyala method for generating a consensus of expert opinion. Responses were coded and scored, and aggregated responses were presented to participants in a consensus round. Participants rated their agreement with each item on a 5-point Likert scale from strongly agree to strongly disagree. Indicators that reached a consensus index of >50% (CI > = 0.51) were retained. Items were categorised per previously defined medical affairs functions to determine the scope of the definition. A comparative content analysis using a previous definition identified in the literature was conducted to determine the utility of the definition generated here.
Results: In total, 11 MAPPs generated 15 unique items to define medical affairs. Item awareness indices ranged from 0.24 (‘communication/education’) to 1.00 (‘design/strategy’). All items had a CI of more than 0.5 and were included in the final definition. All items could be categorised per previously defined medical affairs functions. Comparative content analysis showed that our definition varied in four ways: the designation of medical affairs as a medical specialty (and its primary aim, therefore, is to protect patients), the leadership of medical affairs in medicine adoption, the generation of real-world evidence and the specification of distinct stakeholders who benefit from medical affairs.
Conclusion: A standard definition of medical affairs that incorporates the key principles of medical affairs as a medical specialty that leads medicine adoption and generates real-world evidence for specific stakeholders may protect and further the interests of patients by governing practice and policy.
Introduction
While research has charted the evolution of medical affairs (Jain, 2017; Bedenkov et al., 2020; Ashkenazy, 2020) and medical affairs pharmaceutical physicians (MAPPs) (Setia et al., 2018; Sweiti et al., 2019), there is a lack of peer-reviewed research on the exact functions and scope of both the profession and the field of study, including a lack of standardised definitions. Standardised definitions are needed in the medical field to optimise research and clinical practice such that the impact of the profession on patient outcomes can be assessed and enhanced (Armstrong and Mouton, 2018). In other words, to determine and evaluate best practice guidelines in medical affairs, we must first determine and agree upon the scope of practice. Definitions determine what is measured in research and may impact the validity of results (Patino and Ferreira, 2018) as well as the ability of researchers to interpret and replicate findings (Armstrong and Mouton, 2018). As such, definitions guide both clinical practice and the research that informs it and are, therefore, needed to progress the utility of medical affairs within the pharmaceutical industry for the ultimate benefit of patients.
Previous work has addressed the functions and unique value of MAPPs to pharmaceutical companies (Jandhyala, 2022), but as yet, there has been no empirically generated definition of medical affairs. While definitions have been proposed within empirical studies on related topics (Jain, 2017; Maeda, 2021), and growing attention has been given to what changes have occurred in the role of medical affairs post-COVID-19 (Rajadhyaksha, 2020; Ghosh et al., 2021), there is no consensus on what constitutes medical affairs and its boundaries of scope. Different understandings of medical specialties may affect how they are practiced and regulated as well as healthcare policy and how training is governed (Jamoulle et al., 2017). Additionally, organisational studies of professional functions have suggested that role scope is determined by the position of the professional and the hierarchical level of the function within an organisation (Rieg, 2018). Preliminary evidence from a pilot study has suggested that medical affairs may not be prioritised within pharmaceutical companies in terms of hierarchy (Jandhyala, 2020a), despite the key role of MAPPs in satisfying distinct multiple external stakeholder requirements (Keene et al., 2020; Jandhyala, 2021a) for the successful adoption of medicines (Jandhyala, 2021b; Jandhyala, 2022).
The aim of this study was to generate a definition of medical affairs using a validated empirical method to promote the appropriate positioning of the MAPP specialty within the hierarchy in pharmaceutical companies to ensure that MAPPs are given sufficient role scope to fulfil their duty to patients, companies and their professional regulators.
Materials and Methods
Participants and Recruitment
A total of 13 MAPPs were recruited using convenience sampling via professional networks and invited to participate in the MAPP evidence generating programme. The programme comprised several research projects focused on the professional role of MAPPs within the pharmaceutical industry and was carried out over a 12-month period from December 2020 to December 2021. This project was carried out between October and November 2021. Over the course of the programme, two MAPPs dropped out, leaving 11 in the analysis for this project. To be included, participants had to have at least 2 years of global or regional medical affairs experience at a global pharmaceutical company with offices in the United Kingdom. There was no geographic limitation for inclusion. While 10 participants were located in the United Kingdom at the time of study, the context was global, as participants were responsible for global medical affairs as well as for a specific range of EU and US territories (Switzerland, Germany, Ireland, the Nordics, the United States and the United Kingdom). Written informed consent was obtained from all participants after providing information about the study and before the study commenced. Responses were anonymised, and consensus round list items were not identifiable to particular participants. In accordance with international regulations, ethical approval for this study was granted by King’s College London Research Ethics Committee (Reference number: MRA-21/22-26399).
Development of a Definition for Medical Affairs Using the Jandhyala Method for Generating a Consensus of Expert Opinion
MAPPs were invited to complete an anonymous qualitative online survey about what they believed should be included in a definition of medical affairs using a consensus method known as the Jandhyala method (Jandhyala, 2020a). The Jandhyala method is a validated novel approach that is distinct from other consensus methods, such as Delphi and modified-Delphi approaches, as it contains metrics at the awareness and consensus stages to provide a quantification of participants’ awareness of, and agreement with, each list item generated (Jandhyala, 2020b). It has been used in previous work to develop and validate quality of life scales, disease-severity scales and core datasets (Damy et al., 2021; Jandhyala, 2021c) and is conducted in two rounds of online surveys, Awareness Round (1) and Consensus Round (2).
For Awareness Round 1, the online survey invited participants to provide at least three and up to 50 free-text responses, each referring to one item they believed should be included in the definition in response to the following question: What is your definition of medical affairs, including all components you feel constitute the discipline? All responses were coded by two research analysts, with discrepancies settled by the author. Participants’ survey responses received a score of one for each code they referred to. This comprised the awareness score, which showed how much knowledge each participant contributed. We constructed a definition from participants’ aggregated coded responses using standard grammatical rules as follows and presented this to participants in an anonymised online survey for Consensus Round 2:
Medical Affairs is the medical speciality that protects patients’ interests by regulating pharmaceutical company activities and leads medicine adoption through the design, implementation and communication of real-world evidence targeted to the needs of regulators, payors, prescribers, and patients.
We listed the items in the definition (participants’ aggregated codes) and asked participants to rate their agreement with the inclusion of each item in the definition on a 5-point Likert scale from strongly agree to strongly disagree. Items that attained a consensus index of >50% (CI > = 0.51) were retained in the final definition for medical affairs.
Determining the Utility of the Definition
We generated descriptive meanings for each item according to previous findings and categorised items according to previously described MAPP functions(Jandhyala, 2022). To demonstrate the utility of the definition, we conducted a comparative content analysis (Vaismoradi et al., 2013) with the most recent existing definition we could find in the literature, which was as follows: “Medical affairs departments aim to fulfil unmet medical needs through the generation of scientific evidence and to deliver scientific value to key stakeholders and patients. Medical affairs departments aim to fulfil unmet medical needs through the generation of scientific evidence and to deliver scientific value to key stakeholders and patients. People working in medical affairs need to engage in scientific exchange activities with key opinion leaders independent of sales departments. Through these activities, medical affairs ensures that patients receive optimal medical care” (Maeda, 2021). To conduct the content analysis, we coded the definitions per the following analytic parameters: “who/what,” primary aim, primary mechanism, secondary aim, secondary mechanism, beneficiaries and outcome of activities. We assessed semantic similarities and differences across the parameters in the context of previous literature.
Results
In total, 15 unique items were generated during the Awareness Round 1) of the Jandhyala method (Table 1). Item awareness indices ranged from 0.24 (Item 10, “communication/education”) to 1.00 (Item 8, “design/strategy”), which all participants mentioned in Awareness Round 1. There were four items with awareness indices of less than 0.5, including Item 10 (0.24, “communication/education”); Item 7 (0.47, “adoption”); Item 11 (0.41, “real-world evidence”) and Item 12 (0.47, “regulator”). In Consensus Round 2, five items received unanimous agreement for inclusion in the definition, which were Item 1, “medical”; Item 2, “protecting patient interests”; Item 3, “regulating pharma company activities”; Item 7, “adoption” and Item 11, “Real-world Evidence” (see Table 1 for item details). All other items received consensus scores of 0.91, which meant that all items met the threshold for inclusion in the final definition. In the present study, Participants 1, 3, 5, and 7 provided unique items in Awareness Round 1 (Figure 1). Therefore, data saturation, defined as the point at which no further unique items were generated, was reached by a total of four participants after seven participants had provided responses. The final definition for medical affairs was as follows:
TABLE 1. Awareness and consensus scores for items in the medical affairs definition.
FIGURE 1. Data saturation. Bars represent the percentage of unique items generated by participants in order of entry into the study; the line represents the cumulative percentage of unique items, which was achieved by four participants in total.
“Medical Affairs is the medical speciality that protects patients’ interests by regulating pharmaceutical company activities and leads medicine adoption through the design, implementation and communication of real-world evidence targeted to the needs of regulators, payors, prescribers and patients”.
Items of the medical affairs definition could be categorised into four previously defined MAPP functions (Table 2) (Jandhyala, 2022). Content analysis showed that the consensus-generated definition varied from previous definitions in four key ways: the designation of medical affairs as a medical specialty, the leadership of medical affairs in medicine adoption, the generation of real-world evidence and the specification of distinct stakeholders who benefit from medical affairs (Table 3). The previous definition viewed medical affairs as a department in which non-medically trained staff work and failed to specify its regulatory function, referring instead to its independence from commercial functions. The definitions were similar in that they both referred to the generation of scientific evidence for the benefit of patients and stakeholders, but the consensus-generated definition was more specific in that it provided information on the type of evidence medical affairs is concerned with and the distinct stakeholders to whom this evidence is conveyed.