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

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

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

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

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

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

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

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

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

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