China 
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Methods for Analysis of Trials with Changes from Randomized Treatment
Published in Susan Halabi, Stefan Michiels, Textbook of Clinical Trials in Oncology, 2019
Nicholas R. Latimer, Ian R. White
HTA agencies such as NICE have adopted adjustment methods as alternatives to the ITT analysis to adjust estimates for time-to-event outcomes in the presence of treatment switching. Other agencies, such as the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia and the Scottish Medicines Consortium (SMC) appear to have followed suit, whilst the German Institute for Quality and Efficiency in Health Care (IQWiG) seems less open to these methods. Regulatory agencies such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been involved in international workshops on this topic [12,29], and the new draft addendum to ICH E9 appears to suggest that switching adjustment analyses may be presented more regularly to regulators in the future, as assessment of “hypothetical” estimands (including treatment effects in the absence of treatment switches) is legitimized.
Bearing witness
Published in Katja Kuehlmeyer, Corinna Klingler, Richard Huxtable, Ethical, Legal and Social Aspects of Health Care for, 2018
Lucy Jones, Anna Miller, Sabine Fürst, Carolin Bader, Lea Gelfert
The UK and Germany have highly rated health care systems which both aspire to universal access (Schneider et al. 2017). The UK National Health Service (NHS) is a taxation-based system founded on the principle of universal access (NHS 2008; Steele & Devlin, Chapter 7, pp. 112 ff). The German health care system is a social insurance-based system that includes a general obligation for all people to be insured (Institute for Quality and Efficiency in Health Care 2018; Kaltenborn, Chapter 6, p. 101). In practice, health coverage is not universal in either country – the two MdM programmes in Munich and London provide care to people who are excluded from public health care in both health care systems.
Tangled Minds
Published in Alexandra E. Schmidt Hulst, D. Scott Sibley, Contextual Therapy for Family Health, 2018
Alexandra E. Schmidt Hulst, D. Scott Sibley
There is evidence to support the use of psychotropic medication such as antidepressants to treat mental health disorders like depression. However, the effectiveness of these pharmacologic treatments depends on a variety of factors, including the severity of symptoms, patients’ pharmacogenetic profile, and adherence to treatment recommendations (Institute for Quality and Efficiency in Healthcare, 2017). As systemic clinicians, we believe that psychotropic medications alone are not enough to create lasting change in behavioral patterns, coping strategies, or relationship problems that lead to distress for patients.
Supporting rehabilitation stakeholders in making service delivery decisions: a rapid review of multi-criteria decision analysis methods
Published in Disability and Rehabilitation, 2023
Peter T. Cahill, Meaghan Reitzel, Dana R. Anaby, Chantal Camden, Michelle Phoenix, Shelley Romoff, Wenonah N. Campbell
Researchers selected and defined the decision problem in almost all manuscripts included in this review. Only one study featured a decision problem selected by a non-research stakeholder (a national professional association) [33], and another investigated a decision problem that was under consideration at the time by the Institute for Quality and Efficiency in Healthcare in Germany, although the relationship between the study authors (who were based in the Netherlands) and the knowledge user was not clearly described [42]. Both studies were methodological in nature, focusing on aspects of MCDA feasibility and implementation, rather than directly seeking to understand stakeholder preferences and priorities. Another study reported having one client and one caregiver with lived experience on the research project steering committee [74], although the effects of their involvement in methodological or conceptual decisions in that project were not reported. One study regarding client preferences did ground the study within recommendations from a previous Delphi that included clients and clinicians, among other stakeholders [66]. No other studies that specifically aimed to explore clinician, client, or family perspectives clearly indicated involvement of these stakeholder groups in selecting the decision problem, interpreting results, or next steps. Some studies did report confirming the researcher defined decision problem with other stakeholders.
Criteria to Assess Independence in Continuing Medical Education (CME): Independence through Competence and Transparency
Published in Journal of European CME, 2020
Hans-Albert Gehle, Henrik Herrmann
Independent offers (non- sponsored) exist for face-to-face events as well as print and digital media, but may be limited in reach (e.g. CME activities organised by the Chambers of Physicians). In addition, other independent sources of information such as the Cochrane Collaboration, (which is subsidised by the German Government), the Institute for Quality and Efficiency in Health Care (IQWiG), and the Drug Commission of the German Medical Association (AkdÄ), among others, provide indispensable contributions to medical decision making. Critical to the success of such independent providers, however, is the decision of the medical profession regularly to use their offers.
Centralised Full Access to Clinical Study Data Can Support Unbiased Guideline Development, Continuing Medical Education, and Patient Information
Published in Journal of European CME, 2021
Natalie McGauran, Beate Wieseler
A CSR is a standardised full report of a clinical study submitted by a pharmaceutical company to a regulatory authority during the drug approval process [14]. This format is generally required for drug studies, but so far not for studies on medical devices or other non-drug interventions. Including appendices, a CSR may consist of up to several thousand pages and often contains (anonymised) individual patient data (IPD) [12]. Consideration of CSR data (with or without IPD) in evidence syntheses may reverse or supplement the conclusions based on evidence retrieved from conventional, publicly available sources such as journal publications [15–19]. Previously, CSRs were only available to regulatory authorities as confidential information. However, in the past 10 years, CSR data have become increasingly publicly available, for instance, due to mandatory submission within the context of health technology assessment (HTA) in Germany since 2011 [20,21] or after an initiative launched in 2014 by the European Medicines Agency to publish clinical study documents [22]. The former measure was implemented by the German Act on the Reform of the Market for Medicinal Products (AMNOG), introducing the mandatory assessment of new drugs at market entry, the “early benefit assessment” [20,21]. The main rationale for the Act was to inform pricing decisions. The assessment process is described in detail in a previous paper [13]. In short, the pharmaceutical company submits a dossier at market entry that must contain all available evidence, including CSRs, and show the added benefit of the new drug over standard care. The Institute for Quality and Efficiency in Health Care (IQWiG) generates a dossier assessment to inform the decision on added benefit and ultimately pricing negotiations. The dossier and dossier assessment, including the relevant CSR data, are published online.