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- The Value and Importance of a Professional Ethical Code for Medicines
Development: IFAPP International Ethics Framework-
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Abstract: Abstract Pharmaceutical medicine professionals have to face many ethical problems during the entire life span of new medicines extending from animal studies to broad clinical practice. The primary aim of the general ethical principles governing research conducted in humans is to diminish the physical and psychological burdens of the participants in human drug studies but overlooks many additional social and ethical problems faced by medicine developers. These arise mainly at the interface connecting the profit-oriented pharmaceutical industry and the healthcare-centered medical profession cooperating in medicines development. In 2002, the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine developed the International Code of Ethical Conduct for Pharmaceutical Physicians for providing ethical advice for their members to manage the frequently competitive goals characteristic for their specialty. The ethical framework compiled by the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine serves its members by presenting morally acceptable or inacceptable behaviors in frequently encountered controversies arising from competing industrial and healthcare interests in medicines development. The authors selected this format to encourage reflection and debate for finding optimal moral conclusions in specific issues. Many recent examples of serious scientific-ethical misconduct, such as the oxycodone tragedy, the recommendations of unproven useless occasionally dangerous therapies during the coronavirus disease 2019 pandemic, and the withdrawal of many papers containing non-reproducible results, contributed to the increasing loss of trust by the public in science including pharmaceutical medicine. We are convinced that the ethical guidance developed by the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine will encourage its members to reflect intensively on optimal ethical behavior in drug development for strengthening the trust of society in innovative new medicines. Finally, considering the increasingly active participation of non-medically trained scientists in producing and applying complex biological medicines, distant monitoring methods coupled together with artificial intelligence technology in innovative clinical trials, the Ethics Working Group recommended already in 2017 measures to optimize their smooth cooperation and underlined their joint ethical responsibilities in guarding the safety and human dignity of trial participants.
PubDate: 2025-01-28
- Acknowledgement to Referees
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PubDate: 2025-01-25
- Pricing and Impact: Understanding Sales Trends and Price-Volume
Distributions of Antihypertensive Drugs in Europe, USA, and India-
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PubDate: 2025-01-18
- Knowing is Half the Battle: The Factors Leading to Efficient Recruitment
of Representative Samples in Schizophrenia Research-
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Abstract: Background and Objectives Drug development in schizophrenia is limited by the differential scaling of the active treatment and placebo arms of a study, such that, as the number of sites increases, the magnitude of placebo response disproportionately increases. The objective of this article was to identify factors conducive to efficient recruitment as a step towards trial designs allowing recruitment of more participants per site, leading to reduced variability, and potentially a smaller placebo effect. Patients and Methods Using the information of 554 individuals, we calculated the percentage of individuals who were screened, consented, and retained in our research, along with rationale for nonconsent. Independent t tests and Chi-squared tests were performed to compare participant characteristics. Results Out of the 273 individuals who were fully screened, 84 did not progress to the consented stage owing to various reasons, leading to a total of 189 individuals who were screened and consented and a total of 365 individuals who were either incompletely screened or not consented into a study. Individuals with an externally validated medical history showed the highest yield in being consented and retained in research as new participants. In particular, chart reviews from clinics were highly efficient (25.8%) in facilitating new participants’ enrollment, even when these individuals were not actively/prospectively seeking research. The most common reason for nonconsent was difficulty in telephone or email contact. Consenting and nonconsenting participants were similar in demographics, and recruitment sources only differed in their reported substance use. Conclusions Referrals and chart reviews from known clinics were the most efficient method in retaining new participants, highlighting the importance of external validation and communication between research and clinical staff within a system. Consenting participants showed no significant differences from the database as a whole, demonstrating that the study samples were representative. Future studies should aim to confirm the present findings at other academic and commercial research centers.
PubDate: 2025-01-11
- Author’s Reply to Pongpirul: “The Pharmaceutical Year that
was, 2024”-
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PubDate: 2024-12-24
- Comment on: “The Pharmaceutical Year that was, 2024”
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PubDate: 2024-12-24
- Understanding the National Healthcare Ecosystem to Position Medical
Affairs as a Strategic Element: Lessons Learned from AstraZeneca Spain-
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Abstract: Introduction The rapidly evolving healthcare landscape has prompted Medical Affairs (MA) departments within pharmaceutical companies to transition from their traditional role as information providers to becoming strategic partners in the healthcare ecosystem. Responding to the increasing complexity of patient needs and stakeholder dynamics within Spain’s national health system, this shift emphasizes the importance of aligning MA functions with broader healthcare goals. Effective transformation requires in-depth assessments of stakeholder trends and expectations. The objectives of this study were to identify key stakeholders in the Spanish healthcare ecosystem, analyze their trends in detail, and evaluate ways in which our MA department should adapt to address them. Methods To support this strategic transformation, we conducted a dual assessment focusing on the Spanish healthcare ecosystem. Using a combination of desk analysis and stakeholder research, we examined external and internal dynamics affecting the MA department’s role. This approach identified the perspectives and needs of key stakeholders across three main communities: patients, healthcare professionals, and institutional bodies, offering insights into stakeholder-specific expectations and broader industry macrotrends. Results The identification of 16 pivotal stakeholders in Spain’s healthcare ecosystem underscores the complex array of needs and expectations that shape MA’s evolving role. For the patient community, key trends include the demand for accessible information, emotional support resources, and tools to enhance treatment adherence and chronic disease management. Among clinicians and key external experts, there is an increasing need for current medical resources, digital integration in care processes, and collaborative research opportunities. Institutional stakeholders emphasize sustainable integration of therapeutic innovations, budget predictability, and public-private collaboration to enhance healthcare quality and access. Beyond these specific needs, transversal trends affecting all stakeholders were identified, including the acceleration of medical innovation, demand for value-added services, and the expansion of digital tools and data-driven decision making. Macrotrends within the pharmaceutical industry – such as patient-centric approaches, the growth of digital health, and data-focused business models – further shape the industry’s response to evolving healthcare challenges. A unified organizational vision, reflected in shared objectives and priorities, is crucial for cohesive strategy implementation. Conclusion This research underscores the essential role of MA departments in redefining their influence within healthcare systems. By aligning MA activities with stakeholder trends, pharmaceutical companies can reposition MA as a central pillar within the healthcare ecosystem. Our assessment of the Spanish health system provides a strategic framework that can be easily implemented by other MA departments in the industry to adapt to evolving stakeholder dynamics worldwide.
PubDate: 2024-12-23
- Transdermal Drug Delivery Systems: Different Generations and
Dermatokinetic Assessment of Drug Concentration in Skin-
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Abstract: Abstract Transdermal drug delivery systems (TDDS) are a highly appealing and innovative method of administering drugs through the skin, as it enables the drugs to achieve systemic effects. A TDDS offers patient convenience, avoids first-pass hepatic metabolism, enables local targeting, and reduces the toxic effect of drug. This review details several generations of TDDS and the advancements made in their development to address the constraints associated with skin delivery systems. Transdermal delivery methods of the first generation have been consistently growing in their clinical application for administering small, lipophilic, low-dose drugs. Second-generation TDDS, utilizing chemical enhancers and iontophoresis, have led to the development of clinical products. Third-generation delivery systems employ microneedles, thermal ablation, and electroporation to specifically target the stratum corneum, which is the skin’s barrier layer. Dermatokinetics is the study of the movement of drugs and formulations applied to the skin over a period of time. It provides important information regarding the rate and extent to which drugs penetrate skin layers. Several dermatokinetic techniques, including tape stripping, microdialysis, and laser scanning microscopy, have been used to study the intricate barrier properties and clearance mechanisms of the skin. This understanding is essential for developing and improving effective TDDS.
PubDate: 2024-11-01
- Addressing Challenges in Antibiotic Access: Barriers, Implications and
Strategies for Solution-
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Abstract: Abstract Antimicrobial resistance (AMR) poses a significant threat to global public health, disproportionately affecting low- and middle-income countries (LMICs). While excessive antibiotic use is often discussed, the issue of access to antibiotics demands attention. This viewpoint explores the multidimensional nature of the issue of access to antibiotics. We have examined the issue through the lens of social, economic, healthcare structures, manufacturing and supply chain, policy and practices. Inter-relatedness of these issues has also been explored. The review further discusses potential solutions involving but not limited to increased awareness, improvement in healthcare infrastructure, models for sustained manufacturing and supply chains. Additionally, enhancing antimicrobial stewardship at hospital and community levels, empowering healthcare professionals, and emphasizing infection prevention are crucial. Global initiatives that aim to address access challenges, emphasizing collaboration and innovation are important to foster for a sustained response to the issue of antibiotic access.
PubDate: 2024-11-01
- The Pharmaceutical Year that was, 2024
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PubDate: 2024-11-01
- European Pharmaceutical Industry Medical Information: A Role to Play in
the Provision of Medicine-Related Information to Patients-
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Abstract: Abstract European pharmaceutical companies have a professional and legal obligation to provide objective, factual and non-promotional medicine-related information to both healthcare professionals (HCPs) and patients on request and have established Medical Information services to fulfil this need. Also, medicines are supplied with a package leaflet for patients and/or users—this usually includes the contact details for the company’s Medical Information service. There is a large scale of patient enquiry interactions across the European region. A survey conducted in 2021 by the Medical Information Leaders in Europe (MILE) association revealed that 21% of all enquiries managed by Medical Information services in 2020 were from non-HCPs. Eighteen companies collectively managed over 140,000 non-HCP enquiries—while supporting so many patients, this is also a potentially rich source of insights to real-life patient experiences. When interacting with patients, companies are cautious not to interfere with the relationship between the patient and their HCP. This can limit the information provided, with many being referred to their busy treating physicians. Unfortunately, this approach can fall short of patients’ expectations or needs. MILE recognises the potential to be more helpful and companies are keen to evolve to deliver more patient-centric support. MILE member companies have collaborated in the collation and publication of best-practice principles for handling unsolicited requests for medicine-related information from patients, caregivers and members of the general public (MOPs). This will help improve accessibility to quality information support, harmonise the patients’ experience and build confidence in the pharmaceutical industry services. MILE continues to invite stakeholders, including patient associations, HCPs, pharmaceutical companies, regulators and national industry associations to engage and help advance these core principles for handling patient enquiries. This publication does not constitute legal advice; decision making and accountability remains with each pharmaceutical company.
PubDate: 2024-11-01
- Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic
Review-
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Abstract: Background In the context of biosimilar use and switching, a patient’s negative perception of a biosimilar might trigger a nocebo effect, where negative expectations unrelated to its pharmacologic action may lead to worsened symptoms, resulting in less perceived therapeutic benefit or worsened adverse events. Considering the crucial role biosimilars have in reducing health care costs and expanding access to safe biologics globally, it is essential to develop and implement effective strategies to mitigate the possible occurrence of such nocebo effects. Objective The aim of this systematic literature review was two-fold: (i) to review strategies that have been applied and/or tested for minimising the nocebo effect in clinical practice, within and outside the context of biosimilar switching, and (ii) to propose recommendations on useful mitigation strategies to minimise the occurrence of the nocebo effect in the context of biosimilar switching. Methods Biomedical databases PubMed and Embase were screened up until the end of April 2023 with a search string consisting of the following search terms “nocebo”, “biosimilar”, “mitigation”, “strategy”, and “prevention” and related synonyms. The search strategy was supplemented by snowballing of the included studies. The quality of the studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses, the Scale for the Assessment of Narrative Review Articles, and the Mixed Methods Appraisal Tool. Results Of the 1617 identified and screened records, 60 met the inclusion criteria. Among these, 10 (17%) were conducted within the context of biosimilar switching, 7 of which specifically tested strategies to mitigate the nocebo effect. Among the remaining 50 studies conducted outside the biosimilar switching context, 46 tested mitigation strategies. Across the included studies, 13 distinct mitigation strategies were identified, which can be employed within the context of biosimilar switching: (i) open non-verbal communication, (ii) positive framing, (iii) empathic communication, (iv) validating communication, (v) shared decision making, (vi) self-affirmation, (vii) education of patients and health care professionals about the nocebo effect, (viii) education of patients and health care professionals about biosimilars, (ix) soft-skills training for health care professionals, (x) personalised information, (xi) supporting information, (xii) multidisciplinary approach, (xiii) organisation of the switch. Conclusion This review has identified a set of strategies that have been tested to mitigate the nocebo effect, which can be applied by health care professionals in the context of biosimilar switching with the aim of mitigating the occurrence of a nocebo effect. We recommend implementing a combination of mitigation strategies for patients and health care professionals to utilise before, during, and after a switch. It should be noted that given the limited number of studies specifically testing nocebo mitigation strategies within the biosimilar switching context to date, it is not yet possible to draw definite conclusions about the effect size of each mitigation strategy individually or in combination.
PubDate: 2024-11-01
- Evaluation of the Effectiveness of Additional Risk Minimization Measures
for Ixazomib Citrate for Relapsed/Refractory Multiple Myeloma in Japan: A
Web-Based Survey Among Pharmacists-
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Abstract: Background Ixazomib citrate (IXA) in combination with lenalidomide and dexamethasone (IRD therapy) has been approved for the treatment of relapsed or refractory multiple myeloma. In Japan, as these three drugs have different dosing schedules, dosing instructions for patients have been prepared and distributed to patients via healthcare professionals to promote an understanding of the appropriate dosing regimen, as an additional risk minimization measure (aRMM). Objectives This survey aimed to investigate whether the aRMM material is being utilized for the adequate use of IXA. Methods A web-based questionnaire survey was conducted among in-hospital pharmacists in Japan who instructed patients on IXA dosing for IRD therapy. The primary endpoint was the proportion of pharmacists who provided patients with the contents of the aRMM material (i.e., how to take IXA). The secondary endpoints were the proportion of pharmacists who had obtained the aRMM material and the proportion of pharmacists who understood the importance of explaining how to take IXA to patients. Results Of the 330 pharmacists who completed the questionnaire, 93.0% answered that they had explained how to take IXA to patients. Of those who answered that they had explained how to take IXA, 33.2% responded that they had experience in using the aRMM material. In addition, 37.6% of the pharmacists answered that they had obtained the aRMM material. Moreover, 95.8% stated that they knew how to take IXA, and 90.3, 9.1, 0.3, and 0.3% of pharmacists answered that the importance of explaining how to take IXA was “very important,” “probably important,” “less important” and “not important,” respectively. Conclusions How to take IXA was explained to patients by pharmacists and the aRMM material was utilized at the time of the explanation, indicating that the aRMM material contributes to the promotion of the appropriate use of IXA.
PubDate: 2024-09-01
- Artificial Intelligence in Medical Affairs: A New Paradigm with Novel
Opportunities-
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Abstract: Abstract The advent of artificial intelligence (AI) revolutionizes the ways of working in many areas of business and life science. In Medical Affairs (MA) departments of the pharmaceutical industry AI holds great potential for positively influencing the medical mission of identifying and addressing unmet medical needs and care gaps, and fostering solutions that improve the egalitarian and unbiased access of patients to treatments worldwide. Given the essential position of MA in corporate interactions with various healthcare stakeholders, AI offers broad possibilities to support strategic decision-making and to pioneer novel approaches in medical stakeholder interactions. By analyzing data derived from the healthcare environment and by streamlining operations in medical content generation, AI advances data-based prioritization and strategy execution. In this review, we discuss promising AI-based solutions in MA that support the effective use of heterogenous information from observations of the healthcare environment, the enhancement of medical education, and the analysis of real-world data. For a successful implementation of such solutions, specific considerations partly unique to healthcare must be taken care of, for example, transparency, data privacy, healthcare regulations, and in predictive applications, explainability.
PubDate: 2024-09-01
- Automated Mass Extraction of Over 680,000 PICOs from Clinical Study
Abstracts Using Generative AI: A Proof-of-Concept Study-
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Abstract: Background Generative artificial intelligence (GenAI) shows promise in automating key tasks involved in conducting systematic literature reviews (SLRs), including screening, bias assessment and data extraction. This potential automation is increasingly relevant as pharmaceutical developers face challenging requirements for timely and precise SLRs using the population, intervention, comparator and outcome (PICO) framework, such as those under the impending European Union (EU) Health Technology Assessment Regulation 2021/2282 (HTAR). This proof-of-concept study aimed to evaluate the feasibility, accuracy and efficiency of using GenAI for mass extraction of PICOs from PubMed abstracts. Methods s were retrieved from PubMed using a search string targeting randomised controlled trials. A PubMed clinical study ‘specific/narrow’ filter was also applied. Retrieved abstracts were processed using the OpenAI Batch application programming interface (API), which allowed parallel processing and interaction with Generative Pre-trained Transformer 4 Omni (GPT-4o) via custom Python scripts. PICO elements were extracted using a zero-shot prompting strategy. Results were stored in CSV files and subsequently imported into a PostgreSQL database. Results The PubMed search returned 682,667 abstracts. PICOs from all abstracts were extracted in < 3 h, with an average processing time of 200 s per 1000 abstracts. A total of 395,992,770 tokens were processed, with an average of 580 tokens per abstract. The total cost was $3390. On the basis of a random sample of 350 abstracts, human verification confirmed that GPT-4o accurately and comprehensively extracted 342 (98%) of all PICOs, with only outcome elements rarely missed. Conclusions Using GenAI to extract PICOs from clinical study abstracts could fundamentally transform the way SLRs are conducted. By enabling pharmaceutical developers to anticipate PICO requirements, this approach allows for proactive preparation for the EU HTAR process, or other health technology assessments (HTAs), streamlining efficiency and reducing the burden of meeting these requirements.
PubDate: 2024-09-01
- P.O.L.A.R. Star: A New Framework Developed and Applied by One Mid-Sized
Pharmaceutical Company to Drive Digital Transformation in R&D-
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Abstract: Abstract Digital transformation has become a cornerstone of innovation in pharmaceutical research and development (R&D). Pharmaceutical companies now have an imperative to embrace transformation, including mid-sized and small-sized companies despite resource limitations that do not allow economies of scale compared with larger organizations. This article describes the journey undertaken by Chiesi to develop an efficient framework to drive digital transformation along its R&D value chain with the objective of building and refreshing a clear roadmap and relevant priorities, together with identifying and enabling new digital capabilities and skills within R&D, defining tools and processes that will guide Chiesi activities in the space up to mid-long term. This work has led so far to five main achievements, which align with the steps in the framework: a strategically aligned roadmap with key focus areas for digital transformation and a dedicated team to lead the effort; a common language for data across the R&D value chain; an internal mindset that’s open to innovation and participation in key external networks and consortia; a set of quick-win use cases for the new framework; and a defined set of Key Performance Indicators (KPIs) and monitoring tools for digital transformation. The work presented here demonstrates that R&D digital transformation should represent an ongoing process to enable cross-functional collaboration and integration within complex corporate environments that face an ever-growing volume of diverse data, to efficiently support business needs, and to ensure a positive impact on patient care.
PubDate: 2024-08-09
- Cultivating Excellence: Future-Proofing Medical Affairs with Tailored
Talent Programs-
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Abstract: Abstract In today’s rapidly growing healthcare landscape, the role of Medical Affairs within pharmaceutical companies has transitioned from a traditional support function into a strategic one. Amidst acute challenges such as evolving globalization, digitization, and healthcare trends, effective talent development and professional standards in Medical Affairs emerge as a pivotal cornerstone to future-proof pharmaceutical companies. This article explores strategies, perspectives, and best practices for enhancing talent development with medical or natural sciences background in the field of Medical Affairs. From the historical development of Medical Affairs, we cover current challenges and provide a comprehensive approach to talent development strategies of next-generation talents in Medical Affairs. Drawing upon current literature and personal experiences, we discuss various aspects relevant for designing targeted training programs, fostering interdisciplinary collaboration, and enhancing both technical and soft skills essential for success in Medical Affairs roles. Furthermore, we highlight the significance of company-internal rotational programs in exposing talents to different facets of Medical Affairs. We advocate for a flexible and individualized approach to talent development, allowing next-generation talents to pursue personal interests and contribute to innovative projects. Overall, this article offers practical recommendations for pharmaceutical companies aiming to optimize their local talent development initiatives in Medical Affairs and align them with the evolving needs of the healthcare landscape.
PubDate: 2024-08-01
- Statistical Signal Detection Algorithm in Safety Data: A Proprietary
Method Compared to Industry Standard Methods-
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Abstract: Introduction Several quantitative methods have been established, in pharmacovigilance, to detect signals of disproportionate reporting (SDRs) from databases containing reports of adverse drug reactions (ADRs). The signal detection algorithms (SDAs) and the source of the reporting per product vary, but it is unclear whether any algorithm can provide satisfactory performance using data with such large variance factors. Objective Determine the appropriate SDA for Biogen’s internal Global Safety Database (GSD) given the characteristics of the database including frequencies of events, data skewness, outliers, and missing information. Compare performance of standard approaches (EBGM, EB05, PRR, and ROR), well accepted by industry, to a Biogen-developed Machine Learning (ML) Regression Decision Tree (RDT) model, across several Biogen products, to determine a champion SDA. Methods All data associated with seven marketed Biogen products were chosen and a historical subset of reported ADRs were considered. Six SDAs (five common industry disproportionality methods) and RDT were evaluated. The SDRs were calculated on training and test data composed of quarterly reporting intervals from 2004–2019. The performance measures used were sensitivity, precision, time to detect new events, and frequency of detected cases for each algorithm for each product. Outcomes in the test data are known a priori and easily compared to predicted outcomes. Validation was performed via rates of misclassification. This work solely represents Biogen’s internal information, intentionally chosen to serve the performance review of its signal detection systems, and results will not necessarily be generalizable to other external sources. Results Several algorithms performed differently among products, but no one method dominated any other. Performance was dependent on the thresholds used to define a signal according to different criteria. However, those different statistics subtly influenced the achievable performance. The relative performance of RDT and Medicines and Healthcare products Regulatory Agency (MHRA) algorithms were superior and paired across products. A reduction in precision for all methods spanning the products was present. Hence, companies evaluating signal detection approaches, search for innovative methods to minimize this effect. Conclusions In designing signal detection systems, careful consideration should be given to the criteria that are used to define SDRs. The choice of disproportionality statistics does not affect the achievable range of signal detection performance. These choices should consider mainly ease of implementation and interpretation. The implementation of a method is specific to its accuracy. The RDT attempted to take advantage of known methods and compare results on a per-product basis. Many factors influencing ADRs may improve RDT in future efforts. In this experiment, RDT demonstrated superiority in terms of quickest time to detect and capturing of the highest number of ADRs. Next steps include expansion of data for products representing other indications and testing models in external databases to investigate generalizability of estimates when comparing SDAs.
PubDate: 2024-07-13
- How Can General Managers Best Leverage Medical Affairs Now and in the
Future'-
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Abstract: Abstract General managers (GMs) play a crucial role as enterprise leaders of the country affiliate of multi-national pharmaceutical companies, balancing needs, objectives and governance across all local functions. One such function, Medical Affairs, has undergone a significant evolution from a support function into a strategic partner and in some organizations a strategic leader supported by the increasing complexity of medications and a shift to more specialized medicines. Although the function has progressed significantly, there is opportunity to elevate Medical Affairs to another level, with GMs and business unit directors (BUDs) recommending increased business acumen, strategic approach, innovation and project management as competencies that could be further cultivated. Examining the current trends in the industry, including the increasing complexity of innovative medicines and patient journeys, a higher burden of evidence for the reimbursement of medicines, innovative data generation opportunities, the changing stakeholder engagement expectations and the focus on corporate reputation, Medical Affairs is positioned as a key to assist in navigating the organization through these complexities. The GM can help to foster the evolving role of Medical Affairs, encouraging lateral moves for broader enterprise mindset, imparting a culture of shared governance responsibilities across functions to encourage innovative thinking and nurture upcoming leaders by investing in training to take advantage of the above trends and deliver best patient and organizational outcomes now and in the future.
PubDate: 2024-07-13
- Endpoints for Pharmacotherapy Trials for Alcohol Use Disorder
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Abstract: Abstract Alcohol use disorder (AUD) is a debilitating disorder, yet currently approved pharmacotherapies to treat AUD are under-utilized. The three medications approved by the US Food and Drug Administration (FDA) for the indication of AUD are disulfiram, acamprosate, and naltrexone. The current landscape of pharmacotherapies for AUD suggests opportunities for improvement. Clinical trials investigating novel pharmacotherapies for AUD traditionally use abstinence-based drinking outcomes or no heavy drinking days as trial endpoints to determine the efficacy of pharmacotherapies. These outcomes are typically measured through patient self-report endorsements of their drinking. Apart from these traditional outcomes, there have been recent developments in novel endpoints for AUD pharmacotherapies. These novel endpoints include utilizing the World Health Organization (WHO) risk drinking level reductions to promote a harm-reduction endpoint rather than an abstinence-based endpoint. Additionally, in contrast to patient self-report measurements, biological markers of alcohol use may serve as objective endpoints in AUD pharmacotherapy trials. Lastly, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) definition of recovery from AUD and patient-oriented outcomes offer new frameworks to consider endpoints associated with more than alcohol consumption itself, such as the provider-patient experiences with novel pharmacotherapies. These recent developments in new endpoints for AUD pharmacotherapies offer promising future opportunities for pharmacotherapy development, so long as validity and reliability measures are demonstrated for the endpoints. A greater breadth of endpoint utilization may better capture the complexity of AUD symptomatology.
PubDate: 2024-07-05
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