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Manhattan, Berlin and New Delhi all need to take action to adapt to climate change and to reduce greenhouse gas emissions. While case studies on these cities provide valuable insights, comparability and scalability remain sidelined. It is therefore timely to review the state-of-the-art in data infrastructures, including earth observations, social media data, and how they could be better integrated to advance climate change science in cities and urban areas. We present three routes for expanding knowledge on global urban areas: mainstreaming data collections, amplifying the use of big data and taking further advantage of computational methods to analyse qualitative data to gain new insights. These data-based approaches have the potential to upscale urban climate solutions and effect change at the global scale.
The National Institute for Health and Care Excellence (NICE) has increasingly agreed to reimburse innovative products with high levels of uncertainty as part of managed access agreements (MAAs) while additional data are collected, through the new Cancer Drugs Fund (CDF) or highly specialized technology (HST) pathways. This research aimed to review the data collection stipulations of current MAAs.
We reviewed all current MAAs entered into between NHS England and manufacturers as of 29 October 2018 and key data were extracted.
Twenty-two MAAs were identified (19 through the CDF; three through HST). All MAAs involved an observational data collection component. The source of observational data collection was existing NHS databases (19/22 MAAs: 86.5 percent), existing independent registries (one MAA: 4.5 percent [ataluren]); bespoke MAA registry maintained by manufacturer (1/22 MAA: 4.5 percent [asfotase alfa]), and registries developed as a part of regulatory approval and maintained by the manufacturer (1/22 MAA: 4.5 percent [elosulfase alfa]). Only eight MAAs (asfotase alfa, ataluren, elosulfase alfa, brentuximab vedotin, venetoclax, ibrutinib, daratumumab, and pembrolizumab) had observational data collection as the primary method of data collection. Additionally, 17/22 MAAs (77 percent; all from the CDF) also required ongoing data collection from clinical trials as a key component of the data collection arrangement.
This research identified observational data collection as a requirement in all MAAs, which is primarily through existing registries (except ataluren, which required development of a bespoke registry), while ongoing trial data collection was limited to the CDF. The relatively low cost of using existing registries to fulfil data requirements, with the ability to achieve reimbursement whilst still collecting data from ongoing RCTs, make MAAs an attractive proposition for manufacturers. NICE reportedly plan to increase use of MAAs, with ongoing NICE consultation for changes in the appraisal process potentially allowing expansion to include all indications, which would mean increased opportunities to explore innovative MAAs to support access in the future.
The National Institute for Health and Care Excellence (NICE) may recommend temporary funding through managed access agreements (MAAs) for oncology drugs (via the Cancer Drugs Fund [CDF]) and highly specialized therapies for rare diseases. MAAs allow for the collection of evidence to address key areas of clinical uncertainty, while providing access of medicines to patients, prior to re-appraisal by NICE. Observational data and other real-world evidence (RWE) are crucial requirements for all MAAs and herein we examine the extent these data are being used to inform HTA decisions at re-appraisal.
Existing MAAs entered into between the National Health Service (NHS) England and manufacturers as of 30 October 2018 were identified; for drug:indication pairings with NICE re-appraisals, all information was reviewed and the key data extracted.
Of the twenty-two MAAs identified, only two drug:indication pairings have been subsequently re-appraised by NICE: BV(brentuximab vedotin):non-Hodgkin lymphoma (’recommended’) and pembrolizumab:relapsed or refractory classical Hodgkin lymphoma (’recommended’). Data from a retrospective questionnaire regarding the proportion of patients that received curative stem cell transplant (SCT) post-BV (from patients who received BV in the old CDF) were accepted to provide sufficient evidence on the post-BV SCT rate by NICE. Meanwhile, for pembrolizumab, long-term survival benefit was the key clinical uncertainty; the primary data collection source was updated phase III randomized controlled trial data. At re-appraisal no reference was made to the observational data component; more mature survival data reduced uncertainty over survival benefits and were sufficient to support a positive NICE recommendation.
Of the twenty-two MAAs to date, only two drugs have been re-appraised thus far, with both receiving positive NICE recommendations. Observational data were successfully used to address key clinical uncertainties regarding subsequent real-world treatment patterns for BV, but observational data were not referred to in the NICE recommendation for pembrolizumab. The re-appraisal of more drugs in the future will clarify the importance being placed on observational data collection requested by NICE for existing MAAs.
The Early Access to Medicines Scheme (EAMS) aims to provide access to medicines prior to market authorization for patients with severe, life-threatening diseases who do not have adequate treatment options. An EAMS designation enables the potential collection of United Kingdom-specific real world evidence (RWE) prior to health technology assessment (HTA) by the National Institute for Health and Care Excellence (NICE). This research evaluates whether RWE is being gathered through the EAMS and utilized to support HTA submissions.
All EAMS designations as of 7 November 2018 were identified from the Medicines and Healthcare products Regulatory Agency website. For products with final NICE guidance, all publicly-available NICE documentation was reviewed.
Sixteen product and indication pairings with an EAMS designation were identified, with 12 having received final NICE guidance (11 were recommended, 3 were recommended for temporary reimbursement via the Cancer Drugs Fund, and 2 were not recommended). Of the 11 recommended products, seven had references to the number of patients or sites with product access through the EAMS, but only one (dupilumab for atopic dermatitis) had detailed data collected during the EAMS period. The manufacturer of dupilumab reported baseline demographics and disease characteristics from a cohort of 35 patients treated under the EAMS to inform the generalizability of trial populations for clinical practice. Follow-up results from this cohort demonstrated that real-world data on dupilumab effectiveness was comparable with the clinical trial data, despite a higher proportion of patients in the real-world cohort receiving immunosuppressant therapy, which makes improvements in efficacy harder to achieve. The committee also noted that the RWE presented supported the understanding of dupilumab's long-term clinical effectiveness and informed assumptions for the economic model.
To date, the majority of products receiving an EAMS designation have not presented RWE at NICE reappraisal. The case of dupilumab illustrated how RWE collected through the EAMS can be used to reduce uncertainty around how clinical trial data can be translated into clinical practice. In the future, RWE may increasingly be used to help inform NICE decisions.
The Cancer Drugs Fund (CDF) was set up in 2011 in England to enable patients to access oncology therapies that are not routinely publicly funded. In April 2016, the CDF became a temporary reimbursement fund under the remit of the National Institute for Health and Care Excellence (NICE) with the aim of collecting observational data to inform subsequent technology appraisals. This study aims to evaluate how the reformed CDF has been utilized in the 18 months since this reform.
NICE Final Appraisal Determinations for Single Technology Appraisals of oncology drugs from (29 July 2016 to 24 November 2017) were identified and key data extracted.
Seventy-four oncology drug:indication appraisals were identified, 54 (73 percent) were recommended/optimized, 10 (14 percent) were not recommended and 10 drug:indication pairings (14 percent: osimertinib, brentuximab vedotin, pembrolizumab, olaratumab, obinutuzumab, venetoclax, nivolumab [3 indications], and ibrutinib) were referred to the CDF. For most, the greatest uncertainty in their cost-effectiveness analyses related to their survival benefits, intended to primarily be resolved through subsequent clinical trial readouts. However, for venetoclax, ibrutinib and brentuximab, the main areas of uncertainty (relating to comparative survival benefit, pre-progression mortality, and rate of subsequent stem cell transplants, respectively) are expected to be resolved primarily through observational data collected under the CDF.
The newly reformed CDF has been utilized in a minority of cases. Typically, the CDF acts as a temporary access mechanism for treatments that receive market authorization based on early/single-arm trial data until longer-term and/or Phase III data are available. However, venetoclax, brentuximab, and ibrutinib demonstrate how the CDF may address significant areas of uncertainty through the collection of uncontrolled observational data. For venetoclax, with only single-arm supportive clinical trial data, observational data of this intervention and appropriate comparator are to be collected, providing a potential case study of how to appropriately manage reimbursement in the face of significant clinical uncertainty.
In recent years, the National Institute for Health and Care Excellence (NICE) has increasingly agreed to reimburse innovative products with high levels of uncertainty as part of managed access agreements (MAAs) while new data are collected; namely, this has occurred through the new Cancer Drugs Fund (CDF) and highly specialized technology (HST) appraisal pathway. This research aimed to provide a review of ongoing data collection arrangements as part of MAAs agreed with NICE.
We reviewed all current MAAs entered into between the National Health Service (NHS) England and manufacturers as of 24 November 2017 and extracted relevant information related to the data collection arrangements.
Thirteen MAAs were identified (10 through the CDF; 3 through HST). All MAAs involved an observational data collection agreement. The source of observational data collection was existing NHS databases (11 MAAs: 85 percent), existing independent registries (1 MMA: 8 percent [ataluren]); bespoke MAA registry maintained by manufacturer (1 MAA: 8 percent [asfotase alfa]), and registries developed as a requirement for regulatory approval and maintained by the manufacturer (1 MAA: 8 percent [elosulfase alfa]). Only 4 MAAs (asfotase alfa, ataluren, elosulfase alfa, and venetoclax) had observational data collection as the sole basis of the data collection agreement. The other 9 MAAs (69 percent; all from the CDF) also required on-going data collection from clinical trials as a key component of the data collection agreement.
This research shows that current MAAs have predominantly utilized either ongoing data collection (e.g. from RCTs) or existing registries to date for which limited additional set-up administration and costs would be required. However, NICE plan to increase the use of MAAs, with ongoing NICE consultation for changes in the appraisal process to expand MAAs to include all indications. In future, manufacturers will have more opportunities to explore and leverage innovative and bespoke MAAs to help achieve access.
The Protoplanetary Discussions conference—held in Edinburgh, UK, from 2016 March 7th–11th—included several open sessions led by participants. This paper reports on the discussions collectively concerned with the multi-physics modelling of protoplanetary discs, including the self-consistent calculation of gas and dust dynamics, radiative transfer, and chemistry. After a short introduction to each of these disciplines in isolation, we identify a series of burning questions and grand challenges associated with their continuing development and integration. We then discuss potential pathways towards solving these challenges, grouped by strategical, technical, and collaborative developments. This paper is not intended to be a review, but rather to motivate and direct future research and collaboration across typically distinct fields based on community-driven input, to encourage further progress in our understanding of circumstellar and protoplanetary discs.
Although early modern natural philosophers were interested in the relationship between biological and psychological processes, psychology remained a branch of philosophy or theology. Then nineteenth-century physiologists demonstrated experimentally that neuromuscular functions, perceptual processes, and mental operations were interdependent, a consistent finding that created space for a natural-science psychology. Some German scholars, then British, French, US, and Russian scientists began to adopt physiologists’ methodology to analyze conscious experience of sensory-motor functions and answer such philosophical questions as:
What is a mind? Of what does it consist? How is it related to the brain?
What roles do biology and evolution play in psychological processes?
How do psychological capacities develop?
How do humans gain knowledge of the empirical world? How do physical phenomena become sensations? How do emotions and thoughts originate?
What is an action? How is action related to emotion, thought, and will?
How do humans remember their experiences?
What is a self? How is it related to other selves?
What is the individual’s relation to society?
In answering these questions many new psychologists used extant language concerning brain–behaviour relations and evolutionary adaptation. They adopted biological notions, expounded by Alexander Bain and Herbert Spencer, about cerebral localization, sensory-motor activity, and the association of ideas (R. M. Young, 1970). In addition, Gustav Fechner’s psychophysics, “the institutionalization of laboratory instruction” (Ash, 2003, p. 253), and British innovations in statistical analyses of population data became the components of natural-science Psychology’s methodology.
But early psychologists encountered a problem: they could only provide functional explanations according to physiological sensations and movements, not across all levels of brain and behavioural relations. Thus, while scholars struggled with the insufficiency of purely physiological, contemporary explanations for psychological phenomena, the discipline of Psychology took shape.
In this, the second chapter on human-science Psychology, we trace its origins to the interpretive discipline known as hermeneutics. Then we describe the multiple facets of human-science Psychology as expressed in phenomenological, existentialist, humanistic, and transpersonal psychologies. Although these alternatives to natural-science Psychology initially emerged in continental Europe, they have proved influential elsewhere, including in Anglo-American nations.
The aims of this chapter are to describe:
The pivotal problem of interpretation in Psychology and how the discipline of hermeneutics is a viable solution.
Wilhelm Dilthey’s foundational distinction between the natural sciences and the human sciences and his approach to studying human mental life.
The contributions to Psychology of Eduard Spranger and Karl Jaspers, who extended, modified, and applied Dilthey’s concepts and methods.
The concerns of phenomenological and existential psychologies and one particular application, Viktor Frankl’s logotherapy.
The development of “American” adaptations of these European psychologies in the diverse forms expressed by Rollo May, George Kelly, and the humanistic psychologists: Abraham Maslow and Carl Rogers.
Transpersonal psychologies and the historically contested place of spirituality and religion in Psychology, including the implications of psychologists’ incorporating spirituality and religion for the discipline and for individuals’ physical and mental health.
Two themes that summarize the issues addressed in this chapter: the centrality of understanding and interpretation, and the disputed border between body and mind, soul, and spirit.
Alongside developments in natural-science Psychology there emerged a rather different trend in psychological thought and practice known as psychoanalysis. Nineteenth-century philosophy, medicine, and physiology formed the context in which Sigmund Freud developed a theory of unconscious psychological dynamics. Many previous thinkers promoted the idea of unconscious psychic processes, but Freud creatively integrated these ideas into a complex theoretical system. Although he intended it as a natural science, with various practitioners understanding and interpreting it, psychoanalysis evolved into a human science of subjectivity. Many natural-science psychologists have been dismissive of much of psychoanalysis, but some claim that its diverse theories continue to have an enduring influence on psychological thought.
In this chapter, we begin by considering pre-psychoanalytic constructions of unconscious phenomena, emphasizing how Freud was not the first to theorize unconscious processes. Then we review the social, cultural, and political context of Freud’s life to situate the emergence of his ideas. Next you will encounter different threads of psychoanalytic thought and a range of key thinkers. We consider the analytical psychology of Carl Jung, followed by analysts who stressed the sociopolitical, the ego, object relations, postmodern thinking, and gender. Lastly, we examine how psychoanalysis has been received and uniquely developed in different cultural contexts and discuss the possibilities for psychoanalysis in scientific and professional Psychology.
This chapter encompasses psychological thought during the “early modern” period of the seventeenth and eighteenth centuries, known as the Scientific Revolution and the Enlightenment respectively. These developments partially laid the foundation for Psychology. However, early modern scholars were not interested in psychological questions as currently understood. Rather, their beliefs that mind was not material and humans were more than physical objects challenge current psychological assumptions. Furthermore, early modern scholars encountered a rather different cultural context than ours. Accordingly, some historiographical cautions are in order:
Although the terms and concepts that early modern scholars used might appear the same as those in today’s Psychology, their meaning has changed profoundly over centuries.
Few early modern scholars conducted scientific inquiry about psychological phenomena. Rather, late eighteenth-century and nineteenth-century physiologists investigated human biological phenomena with psychological implications (see Chapter 4).
Often contradictory historical accounts exist for those early modern scholars who described psychological phenomena philosophically.
Given these cautions, the aims of this chapter are to describe:
Early modern natural philosophers’ conceptions of psychological phenomena.
The continuities and discontinuities between Psychology’s philosophical heritage and current psychological ideas.
The varieties of psychological discourse during the early modern period.
Three themes that summarize this discourse: compatibility of scientific with theistic thought, objectivity–subjectivity of observation, and a self-contained vs. a relational self.
The Scientific Revolution and the Enlightenment
When modern science and psychological thought began to emerge during the early modern period of the sixteenth and seventeenth centuries, Western culture was in a state of transition. Major societal changes were occurring, including the emergence of mercantile capitalism; expansion and consolidation of political power; colonization of the New World; European journeys to East Asia; violent conflicts over religion; and the use of the magnetic compass, gunpowder, and the printing press, all invented earlier by the Chinese. These developments aided the growth of science and technology, which in turn aided colonial and commercial expansion (R. Porter & Teich, 1992).
In Chapter 1 we discussed diverse meanings of “history,” “psychology,” and “science,” and we explained our critical-historical orientation to the history and philosophy of psychology. Now we can begin the first stage of our historical journey and consider how psychological questions were addressed in ancient, medieval, and Renaissance thought. New scholarship in these areas has generated controversy and new insights especially regarding interpretations of ancient thought (Rossetti, 2004). By addressing this research we clear up some long-standing misinterpretations, however, for the most part we present conventional ideas on the history of philosophy relevant to psychological inquiry.
We start with the ancient Greek philosophers: abstract descriptions of nature introduced by the presocratics, the Socratic method of inquiry, the psychological views of Plato, along with a differing orientation espoused by the Sophists. Then we discuss the psychological ideas of Aristotle. Next we consider developments in science and philosophical psychology during the Roman Empire. We discuss the practical views of therapeutic philosophies and religious reinterpretations of Plato in late antiquity important to medieval ways of thinking. Concerning the Middle Ages, we describe the influential ideas of Augustine and Aquinas on psychological subjects. Regarding the Renaissance, we note the cultural, scientific, and philosophical developments from which a
modern scientific and a more intensely psychological focus began to emerge in the seventeenth century. That stage of our journey continues in Chapter 3.
In this closing chapter we synthesize our account of Psychology’s history and philosophy by presenting multiple critical frameworks for appreciating the past, present, and anticipated future of the discipline. The central theme is that many individuals and groups have described Psychology throughout its history as a problematic science due to its disputed concepts, methodology, and practices, yet they also proposed alternative approaches. We trace these critiques back to Immanuel Kant, Auguste Comte, and nineteenth-century German scholars Friedrich Lange and Rudolf Willy (1855–1918).
Turning to the twentieth century, we review developments in physics, biology, and fuzzy logic, which have implications for Psychology’s scientific and epistemological foundations. Then we describe critiques by social philosophers, Herbert Marcuse and Jürgen Habermas, known as critical theorists, and discuss modern critical approaches in Psychology, including the work of Klaus Holzkamp and current critical psychology.
Next we review more recent critiques of mainstream Psychology from feminist and postmodern perspectives. Then we trace the inclination to critique Psychology to advocates of postcolonial perspectives who assert that psychologists have tended to ignore the discipline’s cultural embeddedness and who propose respect for culturally diverse psychologies. We conclude our review of critiques with a philosophical analysis of the ontology, epistemology, and ethics of Psychology.
In line with the British Psychological Society's recent recommendations for teaching the history of psychology, this comprehensive undergraduate textbook emphasizes the philosophical, cultural and social elements that influenced psychology's development. The authors demonstrate that psychology is both a human (i.e. psychoanalytic or phenomenological) and natural (i.e. cognitive) science, exploring broad social-historical and philosophical themes such as the role of diverse cultures and women in psychology, and the complex relationship between objectivity and subjectivity in the development of psychological knowledge. The result is a fresh and balanced perspective on what has traditionally been viewed as the collected achievements of a few 'great men'. With a variety of learning features, including case studies, study questions, thought experiments and a glossary, this new textbook encourages students to critically engage with chapter material and analyze themes and topics within a social, historical and philosophical framework.
After the Scientific Revolution natural science came to overshadow religious knowledge about nature and human nature. Many natural philosophers became disenchanted with divine and mysterious explanations. They regarded nature as mechanistic, manipulable for human ends, even conquerable. Emergent empirical methods and quantification techniques enhanced scientists’ confidence about their work.
Societally, economically privileged Western nations became increasingly rationalized and bureaucratic. Efficient administration of industry, commerce, and government depended on applications of systematic knowledge; consequently, social management of individuals escalated. In addition, cultivating individual experience became culturally desirable.
This scientific and societal context was early psychologists’ legacy. Their new science blended the study of individuals with practical applications for managing them. To legitimize Psychology, natural-science psychologists adopted the methodology of the natural sciences. They assumed that rigorous application of empirical methods and precise and reliable measurement would reveal socially useful truths.
Empirical methods, then, typically supported by quantification, have been the basis for natural-science psychologists’ claims to scientific knowledge. However, it seems that, rather than being purely objective and universal, these claims depend on modes of conducting research and writing about it that have a social history. In short, societal and scientific contexts guided Psychology’s research traditions.
While a field of study that is “applied” aims to have a practical purpose, a “profession” is generally understood as an occupation practised not only for societal gain but also as a source of personal livelihood. The first and oldest professions recognized were theology, medicine, and law. In the nineteenth century, other learned studies were accepted as professions, such as architecture and engineering. In the twentieth century, professionalization of labour became more pervasive, and accounting, teaching, and nursing as well as Psychology developed professional associations. Professionals were an expanding class of people given the authority to govern and shape the conduct of others (Miller & Rose, 1994). Applied psychology was the first occupational group to emerge entirely from academia (Napoli, 1981).
In this chapter we consider the historical development of applied and professional psychology as it emerged in response to problems of war, education, business, medicine, mental disturbance, crime, sports, community, and environmental concerns as well as the ethical codes and standards of professional conduct developed for clinical and counselling psychology.