CLiNFo.EU Blog
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CLiNFo.EU Blog is your source of information on developments in clinical research: study design, study management, digitalization & data management, biostatistics, and safety. We are a team of Medical professionals dedicated to a common goal of disseminating correct and timely medical and disease information to persons in need of it.
CLiNFo.EU Blog
1M ago
Unveiling the Veiled Influences: Bias in Observational Studies and Its Profound Impacts on Medical Research
By Dr. Michael Obermeier
Observational 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 (1). In this exploration, we focus on the m ..read more
CLiNFo.EU Blog
1y ago
Use of large language models in clinical research (part 2)
By Martina Mršnik and Dr. Christoph Engler
Limitations and concerns
This 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).
Large language models
The involvement of technological giants such as Microsoft and Google in the development of la ..read more
CLiNFo.EU Blog
1y ago
Use of large language models in clinical research (Part 1)
By Martina Mršnik and Dr. Christoph Engler
First experiences – large language models
The 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 (1–3). The talk of the town has been specifically Open ..read more
CLiNFo.EU Blog
1y ago
Clinical trials: increasing the visibility of research with visual abstracts
By Sabine Ditz and Dr. Ramona Schütz
Communication 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. Appealing formats are essential in this context. Visual abstracts provide an elegant solution for the communication of scientific results in a clear and concise way ..read more
CLiNFo.EU Blog
1y ago
Prüfzentren: Wie findet man zuverlässige Partner für klinische Prüfungen? Ein Interview
Dr. Andrea Röthler | GKM Gesellschaft für Therapieforschung mbH
Cornelia Wolf | innoVance GmbH
Mit den „richtigen“ Prüfzentren Zeit und Geld sparen
Die Aktivitäten der Prüfzentren sind entscheidend für den Erfolg der klinischen Prüfung.
Die realistische Einschätzung der Anzahl an Patienten/Patientinnen ist ein Qualitätskriterium zur Auswahl von Prüfzentren.
Die regelmäßige Überprüfung der Rekrutierungsrate und gezielte Maßnahmen zur Steigerung der Rekrutierung tragen dazu bei, k ..read more
CLiNFo.EU Blog
1y ago
Synergieeffekte bei Zertifizierung und Erstattung digitaler Gesundheitsanwendungen
Dr. Andrea Röthler | GKM Gesellschaft für Therapieforschung mbH
Dr. Pamela Aidelsburger | innoVance GmbH
Zwei Expertinnen für Zertifizierung und Erstattung – ein Ergebnis ihres Gesprächs:
Gut geplant können Synergien in den beiden Prozessen genutzt werden.
Bereits bei der Produktentwicklung und Zertifizierung planen, wie der Weg in die Erstattung aussehen könnte.
Schon bei der Konformitätsbewertung müssen die Weichen zur Aufnahme ins DiGA-Verzeichnis richtig gestellt werden.
Synergien lass ..read more
CLiNFo.EU Blog
1y ago
Das GKV-Finanzstabilisierungsgesetz und die Folgen für das AMNOG
Am 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 für die Zukunft gesichert werden.
Mit dem GKV-FinSt wurden auch Bestandteile des Arzneimittelneuordnungsgesetzes (AMNOG) verändert. Im Folgenden soll darauf eingegangen werden, was die wesentlichen Änderungen sind, welche Konsequenzen sie haben und welche Reaktionen sie hervorriefen.
Änderungen und Konsequenzen
Senkung der Umsatz ..read more
CLiNFo.EU Blog
1y ago
EU HTA Regulation: relevance, challenges and outlook
German version below
Authors:Julia Schmidt | Formerly Research Assistant
Laura Suhlrie | Business Development Management
What is HTA and what are its objectives?
HTA 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. Therapeutic and diagnostic procedures as well as more complex health care services such as ca ..read more
CLiNFo.EU Blog
1y ago
Orphan Drugs in the process of the German Act on the Reform of the Market for Medicinal Products (AMNOG) – Quo Vadis?
German version below
The 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.
Definition Orphan Drugs
If a disease affects ≤ 5 people per 10,000 inhabitants, it is called an or ..read more
CLiNFo.EU Blog
1y ago
Artificial Intelligence (AI) in clinical research: transformation of clinical trials and status quo of regulations
Artificial 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. The drug received authorization for emergency use by the FDA in 2021 (1).
Different industries increasingly use AI throughout the full drug discovery process a ..read more