{"id":5459,"date":"2015-07-15T11:37:28","date_gmt":"2015-07-15T09:37:28","guid":{"rendered":"https:\/\/www.gkm-therapieforschung.de\/blog\/"},"modified":"2019-11-07T10:01:07","modified_gmt":"2019-11-07T09:01:07","slug":"blog","status":"publish","type":"page","link":"https:\/\/www.gkm-therapieforschung.de\/en\/blog\/","title":{"rendered":"Blog"},"content":{"rendered":"

Blog<\/h1><\/span>
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Please note that our specialist articles are published on our knowledge base for clinical research \u201cCliNFo.EU\u201d.<\/a>
\nSome of these articles are available in German language only.
\nBy clicking on an article you will be redirected to this page.<\/p>\n<\/div>

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tIMPs vs. AxMPs: What\u2019s the Difference and Why Does It Matter?\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tIn clinical trials, distinguishing between Investigational Medicinal Products (IMPs) and Auxiliary Medicinal Products (AxMPs or AMPs) is essential for regulatory compliance, robust trial design, and patient safety.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDas Forschungsdaten­zentrum Gesundheit \u2013 eine neue Datengrundlage f\u00fcrs AMNOG Verfahren?\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tMit dem neuen Forschungsdatenzentrum Gesundheit (FDZ Gesundheit) werden die Abrechnungsdaten der gesetzlichen Krankenversicherungen erstmals zentral f\u00fcr datengest\u00fctzte Gesundheitsforschung nutzbar gemacht.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tReal-World Evidence\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tReal-World Evidence (RWE) is clinical evidence regarding the use, potential benefits, and\/or risks of a medical therapy. It is derived from the analysis of real-world data (RWD). \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\u00c4nderungen in der Verfahrensordnung des G-BA und Auswirkungen auf die Modulvorlagen f\u00fcr die fr\u00fche Nutzenbewertung\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\u00c4nderungen in der Verfahrensordnung des G-BA und Auswirkungen auf die Modulvorlagen f\u00fcr die fr\u00fche Nutzenbewertung.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDas neue Medizinforschungsgesetz: Was Stakeholder jetzt wissen m\u00fcssen\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tDas Medizinforschungsgesetz (MFG) ist seit Ende Oktober 2024 in Kraft und bringt Neuerungen f\u00fcr alle, die mit der Entwicklung, Zulassung und Herstellung von Arzneimitteln und Medizinprodukten befasst sind. \r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tPharmakovigilanz im Fokus\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\u201ePharmakovigilanz im Fokus: Effektive Meldewege und die h\u00e4ufigsten Fallstricke bei Nebenwirkungsf\u00e4llen\u201c\r\n\r\nErfahren Sie in diesem Vlog (Videoblog), wie Sie die Meldekette optimal nutzen und welche Fallstricke Sie vermeiden sollten, um die Sicherheit Ihrer Patienten zu gew\u00e4hrleisten.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tAnwendungs­begleitende Datenerhebungen (AbD)\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tEine Anwendungsbegleitende Datenerhebung (AbD) ist eine nicht-randomisierte, vergleichende Evidenzgenerierung, die in der Regelversorgung durchgef\u00fchrt wird. Der Gemeinsamen Bundesausschuss (G-BA) kann eine AbD anordnen, wenn die vorliegende Evidenz f\u00fcr ein Arzneimittel nicht zur Quantifizierung eines Zusatznutzens als ausreichend erachtet wird. Betroffen sind Arzneimittel f\u00fcr seltene Leiden (Orphan Drugs) sowie Arzneimittel mit speziellen Zulassungstypen (bedingte Marktzulassung oder Zulassung unter besonderen Umst\u00e4nden).\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tElectronic Signatures in Clinical Research\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tDigitalisation is profoundly reshaping professional landscapes, and clinical research\u2014a field historically reliant on manually recorded paper documents\u2014is no exception. Paper documents are rapidly being replaced by electronic alternatives, simplifying many aspects of our work. However, ensuring the validity and security of these digital records is paramount, especially when it comes to electronically signed documents in clinical research.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tPitfalls in the clinical trial submission process according to CTR\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tOn January 31, 2022, the long-awaited Clinical Trials Information System (CTIS) portal for submissions under the Clinical Trial Regulation (EU) No. 536\/2014 (CTR) went online. Since then, many of us have already gained first experiences with the portal \u2013 especially since all new clinical trials now have to be submitted via this portal and the deadline for the transition to CTR of ongoing clinical trials is clearly approaching.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tUnveiling the Veiled Influences: Bias in Observational Studies and Its Profound Impacts on Medical Research\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tObservational studies serve as vital tools in uncovering insights into real-world healthcare scenarios. Yet, navigating the intricate landscape of scientific inquiry comes with its own set of challenges, and one of the most elusive adversaries is bias. In the catalogue of bias, developed by scientists of the University of Oxford, around 60 kinds of bias are described that might possibly influence clinical evidence ...\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tPatient Engagement in Drug Development: The Rise of Patient-centric Approaches\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tThe concept of patient centricity has emerged over the last three decades. Although no clear definition of patient centricity exists and the scope for interpretation is wide, putting the patients\u2018 needs in the centre and systematically engaging patients in drug development activities and decision making could be seen as an essence of existing definitions. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tUse of large language models in clinical research (part 2)\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tThis is a follow-up on our previous blog entry on large language models (LLMs) and first experiences using the publicly available chatbots, based on LLMs. It is worth noting that during creation of this blog post, the AI technology already advanced and an upgraded version of model GPT- 3.5 (on which ChatGPT was based) has become available (GPT-4). \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tUse of large language models in clinical research (part 1)\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tThe importance of artificial intelligence (AI) and its potential impact on the workforce has entered the limelight in the last weeks of the year 2022. News outlets and internet websites reported on a groundbreaking achievement in AI: the development of chatbots based on large language models (LLMs) that can be used by the general public in an intuitive, conversational and user-friendly manner \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tClinical trials: increasing the visibility of research with visual abstracts\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tCommunication of scientific results to the public is a very important part of research. The new EU CTR also requires that the results are communicated to the general public in a language understandable to lay persons. Furthermore, social media provides great dissemination channels for researchers to attract readers. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDas GKV-Finanz­stabilisierungs­gesetz und die Folgen f\u00fcr das AMNOG\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tAm 20. Oktober 2022 wurde das GKV-Finanzstabilisierungsgesetz (GKV-FinSt) mit den Stimmen der Ampel-Koalition verabschiedet. Mit dem Gesetz soll die Finanzierung der gesetzlichen Krankenversicherung f\u00fcr die Zukunft gesichert werden. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tEU HTA Regulation: relevance, challenges and outlook\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tHTA stands for \"Health Technology Assessment\" and is used to systematically and transparently evaluate medical procedures and technologies from different perspectives. It aims to provide evidence-based information for physicians, health authorities, health insurers and patients. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tOrphan Drugs in the process of the German Act on the Reform of the Market for Medicinal Products (AMNOG) \u2013 Quo Vadis?\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tThe special position of Orphan Drugs in the process of the German Act on the Reform of the Market for Medicinal Products (AMNOG, Arzneimittelneuordnungsgesetz) is frequently criticized. In the following article, we will explain the concept of Orphan Drugs, elaborate their particular role and discuss the upcoming changes within the AMNOG process. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tArtificial Intelligence (AI) in clinical research: transformation of clinical trials and status quo of regulations\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tArtificial Intelligence (AI) supported technologies play a crucial role in clinical research: For example, during the COVID-19 pandemic the Biotech Company BenevolentAI found through a machine-learning approach that the kinase inhibitor Baricitinib, commonly used to treat arthritis, could also improve COVID-19 outcomes. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tEU CTR: How to write a good Lay Summary of clinical study results\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tLay summaries are a display of clinical study results intended for study participants and the general public. The aim of a lay summary is not only to enhance understanding of complex medical information, but also to increase transparency in clinical research.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tSimply explained: Drug approval procedures in Europe and the example of COVID-19 vaccines\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tSummary: There are three different marketing authorisation procedures in Europe: the Centralised Procedure (CP), the Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP).\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tElectronic informed consent (eConsent) in clinical research in Europe: opportunities and bottlenecks\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tWhile eConsent has become a reality in the US, Europe is still lagging behind in its implementation. To protect patient rights without compromising on the full potential of clinical research, flexible and dynamic consent formats will be crucial in the future.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDIN EN ISO 14155:2021-05 \u2013 Der neue Standard zur Guten klinischen Praxis f\u00fcr klinische Pr\u00fcfungen mit Medizinprodukten\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tWelche Neuerungen sich durch die \u00dcberarbeitung der DIN EN ISO 14155 ergeben und auf welche zus\u00e4tzlichen Aufgaben m\u00fcssen sich Sponsoren gefasst machen sollten.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tSynergieeffekte bei Zertifizierung und Erstattung digitaler Gesundheitsanwendungen\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tZwei Expertinnen f\u00fcr Zertifizierung und Erstattung \u2013 ein Ergebnis ihres Gespr\u00e4chs: Gut geplant k\u00f6nnen Synergien in den beiden Prozessen genutzt werden.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tPr\u00fcfzentren: Wie findet man zuverl\u00e4ssige Partner f\u00fcr klinische Pr\u00fcfungen? Ein Interview\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tMit den \u201erichtigen\u201c Pr\u00fcfzentren Zeit und Geld sparen. F\u00fcr die Durchf\u00fchrung von klinischen Pr\u00fcfungen kommt es darauf an, Patientinnen und Patienten f\u00fcr die Teilnahme an einer Pr\u00fcfung zu gewinnen. Dies geschieht durch \u00c4rztinnen und \u00c4rzte in Pr\u00fcfzentren, die die Patienten aufkl\u00e4ren, die Einwilligung einholen und die klinische Pr\u00fcfung durchf\u00fchren. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tContract Research Organisationen als Partner f\u00fcr klinische Pr\u00fcfungen mit Medizinprodukten\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tWelche Aufgaben ein Auftragsforschungsinstitut (CRO) als Studien-Dienstleister \u00fcbernehmen kann und wie man das richtige findet. Bisher konnten die Hersteller von Medizinprodukten weitgehend auf klinische Pr\u00fcfungen verzichten und allein \u00fcber die klinische Bewertung nach dem \u00c4quivalenz-Prinzip ihre Produkte auf der Basis von Daten gleichartiger Produkte anderer Hersteller (Literaturweg) bewerten.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tPost-Market Clinical Follow-up zur Generierung klinischer Daten nach Inverkehrbringen\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tWarum wird die klinische Nachbeobachtung, das sogenannte Post-Market Clinical Follow-up (PMCF) so wichtig im Rahmen der \u00dcberwachung nach dem Inverkehrbringen? Welche M\u00f6glichkeiten gibt es, PMCF durchzuf\u00fchren, und welche Bedeutung haben die Ergebnisse aus dem PMCF f\u00fcr die klinische Bewertung nach Inverkehrbringen?\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\teCRF mit integrierter ePRO L\u00f6sung\u2013 native App vs. browser-basierte Variante\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tDer digitale Fortschritt durchdringt das t\u00e4gliche Leben in allen Bereichen. Die getroffenen Ma\u00dfnahmen im Zuge von COVID-19 haben dazu beigetragen, dass diese Entwicklung vor allem im Gesundheitsbereich noch verst\u00e4rkt wird.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tThe course of a pandemic \u2013 epidemiological statistics in times of (describing) a crisis, pt. 2\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tA few weeks into the pandemic, the RKI switched its main reporting indicator from the absolute case numbers to the time dependent case reproduction number R(t). R(t) represents the number of unaffected persons that are infected by an index case. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tThe course of a pandemic \u2013 epidemiological statistics in times of (describing) a crisis, pt. 1\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tThroughout the current Corona pandemic, epidemiological statistics are widely used in everyday life to an unprecedented rate. Various media use different indicators for all kinds of purposes, be it the honest attempt to objectively communicate the risk associated with SARS-CoV-2, or in order to up- or downplay the mortality rates. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tClinical prediction models in the COVID-19 pandemic\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tFacing the world-wide spread of coronavirus disease 2019 (COVID-19) infections with hospitals overcharged and a shortage of medical equipment in several countries, diagnostic and prediction models might help to identify patients with COVID-19 and predict the likelihood of the disease outcome (e.g. severity of disease, recovery, death).\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tInvestigator Initiated Trials (IIT)\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tCan they demonstrate scientific merits and align with corporate objectives? Often initiated by researchers or investigators as a part of an observation, an Investigator Initiated Trial (IIT) or Investigator Sponsored Trial is one of the kind of clinical trials that take up specific questions from clinical care, such as therapy optimization or off-label use, and are usually of no economic interest.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tMove Closer to your Patients in order to Improve Recruitment\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tDigital solutions - such as online study portals \u2013 can bring patients, researchers, and industry closer together. Thereby, they can provide value to sponsors during the planning and patient recruitment stages of clinical trials or observational studies.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tMit Kontinuit\u00e4t in die Zukunft - Verst\u00e4rkung in der Gesch\u00e4ftsleitung\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tGemeinsam mit unserem Advisory Board, Renate E. Hippe, Siegfried K. Hippe und Dr. Dieter Schremmer, haben wir uns entschieden, die Gesch\u00e4ftsleitung der GKM ab April 2019 durch Herrn Rupert Lang zu verst\u00e4rken und freuen uns ganz besonders, die Stelle des Chief Operations Officer (COO) getreu der Tradition in unserem Familienunternehmen aus den eigenen Reihen besetzen zu k\u00f6nnen.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tStandard Deviation and Standard Error \u2013 What is the Difference?\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tWhen studying results of scientific publications one usually comes across standard deviations (SD) and standard errors (SE). However, even both measures are widely used the difference between them is not always clear to the readers. This article aims to clarify some important points and to provide a deeper understanding of SD and SE.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDigitalisierung im Gesundheitswesen, Teil 2\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tDer Mensch ist keine gef\u00fchllose Maschine, die beliebig zerlegt werden kann, um Fehler = Krankheiten und Reparaturen = Therapien einfach so zu erkennen und zu beheben. Die medizinische Forschung ist deshalb in den wichtigsten Disziplinen eine empirische Wissenschaft, also eine methodische Sammlung von Daten und daraus abgeleiteten Erkenntnissen. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDigitalisierung im Gesundheitswesen\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tWir leben im Zeitalter der digitalen Revolution. Was hei\u00dft das eigentlich? Die Entwicklung der Menschheit hat 3 industrielle Revolutionen durchlaufen. Gepr\u00e4gt waren diese durch die unaufhaltsame disruptive Entwicklung und permanente Optimierung der Effizienz von Produktionsmaschinen\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tGKM und interActive Systems: Software f\u00fcr open.med\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tGKM und interActive Systems: Software f\u00fcr open.med\r\nDamit die medizinische Behandlung und die soziale Beratung der open.med-Patient(inn)en besser dokumentiert werden k\u00f6nnen, haben die GKM Gesellschaft f\u00fcr Therapieforschung mbH und der Berliner EDC Software Provider interActive Systems f\u00fcr \u00c4rzte der Welt eine eigene Software entwickelt.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tVom Aussterben bedroht \u2013 gef\u00e4hrdet der Brexit klinische Pr\u00fcfungen in UK?\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tAktuell laufen ca. 1.500 klinische Studien in verschiedenen EU Mitgliedsstaaten, deren Sponsoren ihren Sitz in UK haben. Sch\u00e4tzungen zu Folge werden 50 % dieser Studien auch nach dem Austritt Gro\u00dfbritanniens aus der Europ\u00e4ischen Union (BREXIT) am 30. M\u00e4rz 2019 weiterlaufen. In diesem Zusammenhang stellt sich unweigerlich die Frage: Wie geht es mit den klinischen Pr\u00fcfungen und der Zusammenarbeit mit UK nach dem Brexit weiter?\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tThe Art of Storytelling in Clinical Research, or: Adverse Event Narratives and their Pitfalls\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tIn Clinical Study Reports (CSR), a short description (\u201cnarrative\u201c) of all Serious Adverse Events (SAE) must be provided. In addition, all Adverse Events (AEs) leading to discontinuation, and AEs of special interest, must be included. Such narratives should provide a concise yet comprehensive overview of each case [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tWith Continuity into the Future - Changes onstage and backstage\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tDear partners of GKM, in our opinion, the basis for a good and long-term cooperation is trust and continuity. Since GKM\u2019s foundation in 1981, these values, together with a growing number of motivated employees, enabled us, Siegfried K. Hippe and Renate E. Hippe, to develop the company into an internationally operating CRO.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tMit Kontinuit\u00e4t in die Zukunft - \u00c4nderungen vor und hinter den Kulissen\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tSehr geehrte Partner der GKM, die Grundbausteine f\u00fcr eine gute und langj\u00e4hrige Zusammenarbeit sind nach unserer \u00dcberzeugung Vertrauen und Kontinuit\u00e4t. Mit diesen Werten konnten wir, Siegfried K. Hippe und Renate E. Hippe, die GKM seit ihrer Gr\u00fcndung im Jahre 1981 zusammen mit einer wachsenden Zahl an motivierten Mitarbeitern zu einer international agierenden CRO entwickeln.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDie klinische Bewertung nach der neuen MDR \u2013 de facto Pflicht zur klinischen Pr\u00fcfung\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tDie Neuregelungen der MDR zur klinischen Bewertung werden k\u00fcnftig dazu f\u00fchren, dass deutlich mehr klinische Daten zu den eigenen Medizinprodukten des Herstellers vorliegen m\u00fcssen als bisher, um im Rahmen der klinischen Bewertung klinische Evidenz mit den grundlegenden Sicherheits- und Leistungsanforderungen zeigen zu k\u00f6nnen [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tIntention-To-Treat (ITT) vs. Per-Protocol (PP) analysis: what to choose?\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tDifferences between and characteristics of the Intention-To-Treat (ITT) vs. Per Protocol (PP) principles: which is the method of choice for the primary analysis of your clinical trial?\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tArzneimittelzulassung vs. fr\u00fche Nutzenbewertung \u2013 die Unterschiede\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tH\u00e4ufig gibt es Diskrepanzen zwischen den Designanforderungen der Zulassungsbeh\u00f6rden und der Anforderungen an Studien f\u00fcr die Herleitung eines Zusatznutzens nach \u00a735a SGB V. Die Eignung einer klinischen Studie als Basis f\u00fcr eine Arzneimittelzulassung bedeutet nicht zwangsl\u00e4ufig, dass diese Studie auch f\u00fcr die Bewertung eines Zusatznutzens geeignet ist [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tA hitchhiker\u2019s guide to data review in an ongoing (\u201clive\u201d) study \u2013 part 2: data review for interim analysis\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tIf you are thinking of a clinical trial, you might ask yourself why and how data review for interim analysis can be a topic for a whole article. However, in a non-interventional study there are certain challenges [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tThe end of the eCRF in local language? Workflows for meeting local and global demands in your non-interventional study (NIS)\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tWhat aspects do you need to consider when planning a multi-lingual eCRF? Are regulatory requirements effective 22 November 2017 a cut-off date for the future of eCRFs in local language?\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tWhy the value of on-site monitoring cannot be challenged by remote\/ centralized monitoring\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tThis is not to say we should do as we always did. This is also not to promote unnecessarily frequent monitoring visits or a 100% source data verification (SDV). However, in times were risk-based quality management including centralized monitoring are in the regulatory focus, I feel we forget to reflect the undeniable value that on-site monitoring can give to a clinical study [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tA hitchhiker\u2019s guide to data review in an ongoing (\u201clive\u201d) study \u2013 part 1: data review for pharmacovigilance purposes\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tIn a way, data review for pharmacovigilance purposes is the simplest and yet most demanding kind of data review, as time is a pressing matter in this context. The data are reviewed in different time frames according to the potential risks that arise from them [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"WirWarum eine CRO ihrem Verband beitreten sollte.\" \/>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t

\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tWir haben es getan! <\/br>Warum eine CRO ihrem Verband beitreten sollte.\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tBVMA oder nicht BVMA. Der Bundesverband Medizinischer Auftragsinstitute e.V. (BVMA) gilt als die Interessenvertretung der Auftragsforschungsinstitute (Contract Research Organisations, CRO) in Deutschland. Die Frage, ob GKM sich um eine Mitgliedschaft bem\u00fchen sollte [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\u00c4rzte der Welt open.med goes online\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\u00c4rzte der Welt e.V. bietet in Deutschland seit \u00fcber zehn Jahren Menschen, die keinen oder nur einen eingeschr\u00e4nkten Zugang zum Gesundheitssystem haben, kostenlose medizinische Versorgung und Beratung an. GKM Gesellschaft f\u00fcr Therapieforschung mbH unterst\u00fctzt das Projekt open.med in der online L\u00f6sung der Patientenakte.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tWhat to consider when planning the sample size for a non-interventional study\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tThe determination of an \"adequate\" sample size is an essential part of the statistical planning process. Depending on your type of non-interventional study design and your specific study objectives, there are different approaches for the planning of your sample size [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tActing out? Points to consider when planning to involve actigraphy measurements into your study design\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tFrom a medical perspective, addressing concepts of physical activity and activity capacity, vital signs (like heart rate or blood pressure), and\/or sleep quality in a real-time manner rather than a snap-shot at a visit, make perfect sense and could enrich the value story of novel therapies. However, when planning to involve actigraphy measurements into your study design, there are several points to be considered, including issues of validity, data transfer and data analysis [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDon't panic: It's only the Simpson's Paradox\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tYour results on the overall patient level contradict results on the subgroup level? There is no need to panic. With a deeper look into the data, one can get to the bottom of this observation. [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDas Bewertungsverfahren f\u00fcr Medizinprodukte: erste Erkenntnisse und Empfehlungen\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tF\u00fcr welche Medizinprodukte ist die Bewertung relevant, wie l\u00e4uft das Bewertungsverfahren ab und welche Lehren kann man aus den bisherigen Verfahren ziehen? [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tVerpflichtung zur klinischen Nachbeobachtung (PMCF) von Medizinprodukten\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tDie klinische Bewertung ist fortan w\u00e4hrend des gesamten Lebenszyklus des Medizinprodukts anhand von klinischen Daten zu aktualisieren, die aus der klinischen Nachbeobachtung und der \u00dcberwachung nach dem Inverkehrbringen stammen.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tSAE reporting in the age of digitalisation (eSAE)\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tThe use of electronic data capture (EDC) and electronic case report forms (eCRF) is becoming the gold standard in clinical research. Today, the dream of a paperless (or at least near-paperless) study seems within reach [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"User-friendly\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t

\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tUser-friendly eCRF-design: the key for successful data collection\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tTo ensure a perfectly suited eCRF design many different aspects have to be taken into account also with regard to user-friendliness [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tThe \u201cDo\u2019s and Don\u2019ts\u201d when searching clinical trials registers\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tSearching clinical trial registers is a \u201cmust have\u201d in clinical research and evidence based medicine. However, the different registers have their unique characteristics and there are several issues to be kept in mind when searching clinical trial registers, especially when the standards of evidence based medicine need to be fulfilled [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Stuck\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t

\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tStuck in the middle \u2013 mean vs. median\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tThe mean value of numerical data is without a doubt the most commonly used statistical measure. Anyone who has a basic statistical background knows how to calculate the (arithmetic) mean. However, sometimes the median is used as an alternative to the mean. [...]\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Precision\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t

\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tPrecision medicine clinical trials - How far are we in personalized medicine?\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tUsing precision medicine as an aid to plan clinical trials catches much attention in the present era of drug development. Several innovative precision medicine initiatives have launched clinical trials for complex diseases.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t\t\t
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<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":20,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5459","page","type-page","status-publish","hentry"],"yoast_head":"\nBlog Clinical Research | GKM Gesellschaft f\u00fcr Therapieforschung mbH<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.gkm-therapieforschung.de\/en\/blog\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Blog Clinical Research | GKM Gesellschaft f\u00fcr Therapieforschung mbH\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.gkm-therapieforschung.de\/en\/blog\/\" \/>\n<meta property=\"og:site_name\" content=\"GKM Gesellschaft f\u00fcr Therapieforschung mbH | Full-service CRO\" \/>\n<meta property=\"article:modified_time\" content=\"2019-11-07T09:01:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.gkm-therapieforschung.de\/wp-content\/uploads\/2019\/11\/gkm-gesellschaft-fuer-therapieforschung.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"630\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.gkm-therapieforschung.de\/en\/#organization\",\"name\":\"GKM Gesellschaft f\\u00fcr Therapieforschung mbH\",\"url\":\"https:\/\/www.gkm-therapieforschung.de\/en\/\",\"sameAs\":[],\"logo\":{\"@type\":\"ImageObject\",\"@id\":\"https:\/\/www.gkm-therapieforschung.de\/en\/#logo\",\"inLanguage\":\"en-US\",\"url\":\"https:\/\/www.gkm-therapieforschung.de\/wp-content\/uploads\/2019\/11\/gkm-gesellschaft-fuer-therapieforschung.jpg\",\"width\":1200,\"height\":630,\"caption\":\"GKM Gesellschaft f\\u00fcr Therapieforschung mbH\"},\"image\":{\"@id\":\"https:\/\/www.gkm-therapieforschung.de\/en\/#logo\"}},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.gkm-therapieforschung.de\/en\/#website\",\"url\":\"https:\/\/www.gkm-therapieforschung.de\/en\/\",\"name\":\"GKM Gesellschaft f\\u00fcr Therapieforschung mbH | Full-service CRO\",\"description\":\"Clinical Research Organization f\\u00fcr Auftragsforschung, klinische Studien und nicht-interventionelle Studien f\\u00fcr die Pharma und Medizinprodukte Industrie\",\"publisher\":{\"@id\":\"https:\/\/www.gkm-therapieforschung.de\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":\"https:\/\/www.gkm-therapieforschung.de\/en\/?s={search_term_string}\",\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.gkm-therapieforschung.de\/en\/blog\/#webpage\",\"url\":\"https:\/\/www.gkm-therapieforschung.de\/en\/blog\/\",\"name\":\"Blog Clinical Research | GKM Gesellschaft f\\u00fcr Therapieforschung mbH\",\"isPartOf\":{\"@id\":\"https:\/\/www.gkm-therapieforschung.de\/en\/#website\"},\"datePublished\":\"2015-07-15T09:37:28+00:00\",\"dateModified\":\"2019-11-07T09:01:07+00:00\",\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.gkm-therapieforschung.de\/en\/blog\/\"]}]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","_links":{"self":[{"href":"https:\/\/www.gkm-therapieforschung.de\/en\/wp-json\/wp\/v2\/pages\/5459","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.gkm-therapieforschung.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.gkm-therapieforschung.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.gkm-therapieforschung.de\/en\/wp-json\/wp\/v2\/users\/20"}],"replies":[{"embeddable":true,"href":"https:\/\/www.gkm-therapieforschung.de\/en\/wp-json\/wp\/v2\/comments?post=5459"}],"version-history":[{"count":4,"href":"https:\/\/www.gkm-therapieforschung.de\/en\/wp-json\/wp\/v2\/pages\/5459\/revisions"}],"predecessor-version":[{"id":6323,"href":"https:\/\/www.gkm-therapieforschung.de\/en\/wp-json\/wp\/v2\/pages\/5459\/revisions\/6323"}],"wp:attachment":[{"href":"https:\/\/www.gkm-therapieforschung.de\/en\/wp-json\/wp\/v2\/media?parent=5459"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}