Daniel Furtner

Background: The use of real-world data (RWD) warehouses for research in Asia is on the rise, but current trends remain largely unexplored. Given the varied economic and health care landscapes in different Asian countries, understanding these trends can offer valuable insights. Objective: We sought to discern the contemporary landscape of linked RWD warehouses and explore their trends and patterns in 3 Asian countries with contrasting economies and health care systems: Taiwan, India, and Thailand. Methods: Using a systematic scoping review methodology, we conducted an exhaustive literature search on PubMed with filters for the English language and the past 5 years. The search combined Medical Subject Heading terms and specific keywords. Studies were screened against strict eligibility criteria to identify eligible studies using RWD databases from more than one health care facility in at least 1 of the 3 target countries. Results: Our search yielded 2277 studies, of which 833 (36.6%) met our criteria. Overall, single-country studies (SCS) dominated at 89.4% (n=745), with cross-country collaboration studies (CCCS) being at 10.6% (n=88). However, the country-wise breakdown showed that of all the SCS, 623 (83.6%) were from Taiwan, 81 (10.9%) from India, and 41 (5.5%) from Thailand. Among the total studies conducted in each country, India at 39.1% (n=133) and Thailand at 43.1% (n=72) had a significantly higher percentage of CCCS compared to Taiwan at 7.6% (n=51). Over a 5-year span from 2017 to 2022, India and Thailand experienced an annual increase in RWD studies by approximately 18.2% and 13.8%, respectively, while Taiwan’s contributions remained consistent. Comparative effectiveness research (CER) was predominant in Taiwan (n=410, or 65.8% of SCS) but less common in India (n=12, or 14.8% of SCS) and Thailand (n=11, or 26.8% of SCS). CER percentages in CCCS were similar across the 3 countries, ranging from 19.2% (n=10) to 29% (n=9). The type of RWD source also varied significantly across countries, with India demonstrating a high reliance on electronic medical records or electronic health records at 55.6% (n=45) of SCS and Taiwan showing an increasing trend in their use over the period. Registries were used in 26 (83.9%) CCCS and 31 (75.6%) SCS from Thailand but in <50% of SCS from Taiwan and India. Health insurance/administrative claims data were used in most of the SCS from Taiwan (n=458, 73.5%). There was a consistent predominant focus on cardiology/metabolic disorders in all studies, with a noticeable increase in oncology and infectious disease research from 2017 to 2022. Conclusions: This review provides a comprehensive understanding of the evolving landscape of RWD research in Taiwan, India, and Thailand. The observed differences and trends emphasize the unique economic, clinical, and research settings in each country, advocating for tailored strategies for leveraging RWD for future health care research and decision-making. International Registered Report Identifier (IRRID): RR2-10.2196/43741

Like most private enterprises, the pharmaceutical industry has deeply rooted environmental, social, and governance (ESG) matters that challenge its long-term sustainability. Overcoming these external challenges requires collaborative and proactive steps as well as procedures guiding the adoption of ESG principles by all internal stakeholders. Environmental challenges such as climate change, and in addition the changes in society, have resulted in the need for governance addressing and coordinating efforts. The core function of medical affairs (MA) is connecting with stakeholders within a company and also between the company and external stakeholders. In this article, we describe the involvement of MA in several aspects of ESG, as a contributor, partner, and implementer. MA has a significant opportunity to emerge as a leading function involved in ESG strategies and their tactical implementation. Although the involvement of MA in the environment pillar of ESG is less, the function can implement changes relating to the conduct of meetings, clinical studies, and the digitalization of medical education via virtual platforms. Due to its patient centricity, MA is tasked to address social determinants of health to improve patients’ outcomes. As a linking function within a company and with its external stakeholders, MA can provide proactive input in policy generation and enable effective governance by adherence to standards of accountability, ethics, and compliance, as well as transparency. Championing ESG is a collective responsibility that transcends any single department. It mandates a company-wide commitment. MA represents an essential pivot point in catalyzing the integration of ESG principles within industry, contributing to a healthcare ecosystem that is not merely more sustainable and ethical but also more conducive to patient health and public well-being.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: The use of real-world data (RWD) warehouses for research in Asia is on the rise, but current trends remain largely unexplored. Given the varied economic and health care landscapes in different Asian countries, understanding these trends can offer valuable insights. Objective: We sought to discern the contemporary landscape of linked RWD warehouses and explore their trends and patterns in 3 Asian countries with contrasting economies and health care systems: Taiwan, India, and Thailand. Methods: Using a systematic scoping review methodology, we conducted an exhaustive literature search on PubMed with filters for the English language and the past 5 years. The search combined Medical Subject Heading terms and specific keywords. Studies were screened against strict eligibility criteria to identify eligible studies using RWD databases from more than one health care facility in at least 1 of the 3 target countries. Results: Our search yielded 2277 studies, of which 833 (36.6%) met our criteria. Overall, single-country studies (SCS) dominated at 89.4% (n=745), with cross-country collaboration studies (CCCS) being at 10.6% (n=88). However, the country-wise breakdown showed that of all the SCS, 623 (83.6%) were from Taiwan, 81 (10.9%) from India, and 41 (5.5%) from Thailand. Among the total studies conducted in each country, India at 39.1% (n=133) and Thailand at 43.1% (n=72) had a significantly higher percentage of CCCS compared to Taiwan at 7.6% (n=51). Over a 5-year span from 2017 to 2022, India and Thailand experienced an annual increase in RWD studies by approximately 18.2% and 13.8%, respectively, while Taiwan’s contributions remained consistent. Comparative effectiveness research (CER) was predominant in Taiwan (n=410, or 65.8% of SCS) but less common in India (n=12, or 14.8% of SCS) and Thailand (n=11, or 26.8% of SCS). CER percentages in CCCS were similar across the 3 countries, ranging from 19.2% (n=10) to 29% (n=9). The type of RWD source also varied significantly across countries, with India demonstrating a high reliance on electronic medical records or electronic health records at 55.6% (n=45) of SCS and Taiwan showing an increasing trend in their use over the period. Registries were used in 26 (83.9%) CCCS and 31 (75.6%) SCS from Thailand but in Conclusions: This review provides a comprehensive understanding of the evolving landscape of RWD research in Taiwan, India, and Thailand. The observed differences and trends emphasize the unique economic, clinical, and research settings in each country, advocating for tailored strategies for leveraging RWD for future health care research and decision-making.

Background: Real-world data (RWD) related to patient health status or health care delivery can be broadly defined as data collected outside of conventional clinical trials, including those from databases, treatment and disease registries, electronic medical records, insurance claims, and information directly contributed by health care professionals or patients. RWD are used to generate real-world evidence (RWE), which is increasingly relevant to policy makers in Asia, who use RWE to support decision-making in several areas, including public health policy, regulatory health technology assessment, and reimbursement; set priorities; or inform clinical practice. Objective: To support the achievement of the benefits of RWE in Asian health care strategies and policies, we sought to identify the linked contemporary databases used in real-world studies from three representative countries—India, Thailand, and Taiwan—and explore variations in results based on these countries’ economies and health care reimbursement systems by performing a systematic scoping review. Herein, we describe the protocol and preliminary findings of our scoping review. Methods: The PubMed search strategy covered 3 concepts. Concept 1 was designed to identify potential RWE and RWD studies by applying various Medical Subject Headings (MeSH) terms (“Treatment Outcome,” “Evidence-Based Medicine,” “Retrospective Studies,” and “Time Factors”) and related keywords (eg, “real-world,” “actual life,” and “actual practice”). Concept 2 introduced the three countries—India, Taiwan, and Thailand. Concept 3 focused on data types, using a combination of MeSH terms (“Electronic Health Records,” “Insurance, Health,” “Registries,” “Databases, Pharmaceutical,” and “Pharmaceutical Services”) and related keywords (eg, “electronic medical record,” “electronic healthcare record,” “EMR,” “EHR,” “administrative database,” and “registry”). These searches were conducted with filters for language (English) and publication date (publications in the last 5 years before the search). The retrieved articles will undergo 2 screening phases (phase 1: review of titles and abstracts; phase 2: review of full texts) to identify relevant and eligible articles for data extraction. The data to be extracted from eligible studies will include the characteristics of databases, the regions covered, and the patient populations. Results: The literature search was conducted on September 27, 2022. We retrieved 3,172,434, 1,094,125, and 672,794 articles for concepts 1, 2, and 3, respectively. After applying all 3 concepts and the language and publication date filters, 2277 articles were identified. These will be further screened to identify eligible studies. Based on phase 1 screening and our progress to date, approximately 44% (1003/2277) of articles have undergone phase 2 screening to judge their eligibility. Around 800 studies will be used for data extraction. Conclusions: Our research will be crucial for nurturing advancement in RWD generation within Asia by identifying linked clinical RWD databases and new avenues for public-private partnerships and multiple collaborations for expanding the scope and spectrum of high-quality, robust RWE generation in Asia. International Registered Report Identifier (IRRID): DERR1-10.2196/43741

BACKGROUND real-world data (RWD) relating to patient health status and/or the delivery of healthcare can be broadly defined as data collected outside of conventional clinical trials in the context of databases, treatment and disease registries, electronic medical records, insurance claims, and information directly contributed by healthcare professionals and/or the patients themselves. RWD is used to generate real-world evidence, which is increasingly relevant to policymakers in Asia to support decision-making from several perspectives, including public health policy, regulatory, health technology assessments, and reimbursement, and to set priorities or inform (clinical) practice. OBJECTIVE To support the purpose of achieving the benefits of RWE in Asian healthcare strategy and policy, we sought to identify linked contemporary databases used in real-world studies in three representative countries (India, Thailand, and Taiwan) to reflect the diversity in Asia by performing a systematic scoping review. In this article, we describe the protocol and preliminary literature search for the scoping review. METHODS The PubMed search strategy covered three concepts. Concept 1 was designed to identify potential RWE/RWD studies by applying a variety of MeSH terms (“Treatment Outcome”, “Evidence-Based Medicine”, “Retrospective Studies”, “Time Factors”) and related keywords (e.g. “real-world”, “actual life”, “actual practice”). Concept 2 introduced the three countries (India, Taiwan, and Thailand). Concept 3 focused on data types, by using a combination of MeSH terms (“Electronic Health Records”, “Insurance, Health”, “Registries”, “Databases, Pharmaceutical”, “Pharmaceutical Services”) and related keywords (e.g., electronic medical record, electronic healthcare record, EMR, EHR, administrative database, registry). These searches were combined with filters for the English language and publications in the last 5 years before the search. In the next step, the retrieved articles will undergo two screening phases (phase 1: review of the title and abstract; phase 2: review of full text) in order to identify relevant and eligible articles for data extraction. Data to be extracted from eligible studies will include characteristics of the database itself, region(s) covered, and the patient population. RESULTS The literature search was conducted on Sep 27, 2022 and retrieved 3,172,434 (concept 1), 1,094,125 (concept 2), and 672,794 (concept 3) articles. After applying all three concepts together with the language and publication date filters, 2,277 articles were identified. These articles will be further screened to identify eligible studies. Based on phase 1 screening to date, we estimate that approximately 20% (~450) of the articles will require full-text review to judge their eligibility, and that 100–200 studies will be used for data extraction. CONCLUSIONS We believe that this research will be crucial in nurturing advancement in RWD generation in Asia by identifying linked clinical RWD databases and identifying new avenues for public-private partnerships and multiple collaborations to expand the scope and spectrum of high-quality, robust RWE generation in Asia. CLINICALTRIAL NA

Background: There is an increasingly alarming worsening of mental health among the youth. There remain significant unmet needs for developing innovative, evidence-based technology–enhanced, positive psychology interventions (PPIs) all-inclusive in targeting psychological distress and risk factors related to high-risk behavior commonly encountered in adolescents. Objective: We aim to assess the effectiveness of a hybrid (incorporating both synchronous and asynchronous learning) and holistic (targeting social and emotional learning and tackling risk factors unique for this age group) PPI, “success4life youth empowerment,” in improving well-being in the youth. Methods: Students’ well-being will be assessed by the 5-item World Health Organization Well-Being Index, and hope will be assessed by the 6-item Children’s Hope Scale at week 0, week 8, and week 10, month 6, and month 12. Any improvement in well-being and hope will be measured, estimating the difference in postintervention (week 8 and week 10) and preintervention (week 0) scores by determining the P value and effect size using appropriate statistical tests. Results: This study includes 2 phases: pilot phase 1, delivered by the creators of the succcess4life youth empowerment modules and platform, and phase 2, which will consist of the estimation of scalability through the recruitment of trainers. We hope to start student recruitment by 2022 and aim to complete the results for phase 1 pilot testing by 2023. Conclusions: We anticipate that a primarily web-based, 10-week holistic PPI can support improvement in the mental wellness of the youth and has the potential for effective scalability. International Registered Report Identifier (IRRID): PRR1-10.2196/38463

A number of developments, including increasing regulatory and compliance scrutiny, increased transparency expectations, an increasingly vocal patient, patient centricity and greater requirements for real-world evidence, have driven the growth and importance of medical affairs as a trusted, science-driven partner over the past decade. The healthcare environment is shifting towards a digital, data-driven and payor-focused model. Likewise, medical affairs as a function within the pharmaceutical industry has become more “patient-centric” with strategic engagements embracing payers and patients apart from clinicians. The pandemic has impacted the healthcare industry as well as the function of medical affairs in numerous ways and has brought new challenges and demands to tackle. There is indeed a silver lining due to intense digital transformation within this crisis. The emerging digital innovation and new technologies in healthcare, medical education and virtual communications are likely to stay and advance further. In this review, we discuss how the digital transformation sparked by the pandemic has impacted the medical affairs function in pharmaceuticals and provide further insights and learnings from the COVID-19 era and beyond. Based on the learning and insights, digital innovation in three key strategic imperatives of medical affairs—HCP engagement, external partnerships and data generation will enable medical affairs to become future-fit as a strategic leadership function.

In the USA, an interchangeability designation provides biosimilar sponsors with a pathway for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution for an innovator. No other major health authority links interchangeability to automatic substitution, as all require the involvement of the prescriber or patient in a medication change. This editorial considers the clinical impact and practicality of auto-substitution. First, interchangeability is linked to non-medical switching (NMS), the practice of switching treatment in patients with stable disease for non-clinical reasons. NMS may generate negative sentiment in those unwilling or reluctant to switch, which can adversely impact treatment outcomes (i.e., nocebo effect). Indeed, in real-world studies of tumor necrosis factor inhibitors, discontinuation rates have been shown to be higher in patients switched to biosimilars for non-medical reasons than in historical cohorts maintained on innovators. Second, interchangeability may impede pharmacovigilance and traceability, as not all jurisdictions require innovators and biosimilars to have distinct biologic names. Third, an interchangeability designation from the US Food and Drug Administration only permits a biosimilar to be automatically substituted for its innovator, not other biosimilars (if available). Pharmacist education would be needed to avoid off-label, automatic substitution among biosimilars of a single innovator. Last, once granted, an interchangeability designation exists in perpetuity under current US federal law. However, the supply chains of innovators and biosimilars are maintained independently, with no requirement for reconfirmation of biosimilarity or interchangeability. We feel that additional guidance is needed for the auto-substitution of biosimilars and innovators to become a reality.

Aim: Carers may offer valuable insight into the true health status of patients with rheumatoid arthritis (RA). This multinational, multi‐stakeholder, exploratory study in Australia, China and Japan aimed to enrich our understanding of the role and potential impact of carers on RA management.Method: This study used a 2‐phase sequential mixed methods approach involving 3 key stakeholder groups: rheumatologists, RA patients and carers. The first phase involved an in‐depth qualitative exploratory survey (n = 30), which informed the development of the subsequent quantitative validation survey (n = 908). In both phases, patients and carers provided self‐assessments of disease and support parameters.Results: In the qualitative phase, patients usually understated the amount of physical support required, compared to carers. Rheumatologists underestimated the amount of physical and emotional care required, compared to carers and patients; however, in the quantitative phase, rheumatologists overestimated the level of support provided by carers. Levels of support provided by carers increased as disease severity increased. Active participation of carers in clinical consultations and treatment decision‐making was deemed important by 55% of all patients and 82% of all carers. All stakeholders believed carers’ insights into the physical and emotional conditions of patients were useful and should be considered in clinical decision‐making. Over 95% of rheumatologists reported soliciting input from the carer.Conclusion: Carers provide valuable input that can give clinicians greater insight into the patients’ physical and emotional states, and treatment adherence. Development of standardized carer‐reported outcomes that correlate with patient‐reported outcomes and clinical parameters will ensure clinical meaningfulness and external validity.