Applied Clinical Research

This course has been accredited by tropEd Network for Higher Education Institutions in International Health.

Delve deep into the practical aspects of clinical research with our comprehensive course on Applied Clinical Research. This course provides an extensive overview of clinical studies, emphasizing their designs and the underlying principles of data analysis. Participants will learn the intricacies of protocol development and gain hands-on experience in designing Case Report Forms (CRFs). Dive into the management of clinical studies, grasping the fundamental elements of the clinical trial life cycle, and unravel the broader implications of study outcomes.

Please find here the tentative 2024 course agenda, so you can get a concrete idea of the course content and structure.

1. Clinical Study Designs & Fundamentals of Data Analysis: Understand the diverse landscapes of observational and experimental studies and decipher the basics of data interpretation for answering the scientific research questions under investigation.
2. Protocol Development: Formulate the research question, define primary study objectives, select an appropriate study design, and consider the required statistical parameters.
3. CRF Development: Get equipped with the knowledge and tools to design CRFs that reflect a clear understanding of Clinical Data Management.
4. Study Management: Gain insight into the entire clinical trial life cycle, encompassing regulatory and ethical frameworks, timelines, project execution, quality management, and more.
5. Study Outcomes & Impact: Discern how clinical trial findings can be pivotal, especially in the context of policy development.

By the end of this course, participants will be able to:

• Develop a Clinical Trial Protocol: This includes formulating research questions, outlining primary study objectives, identifying a suitable study design, and considering key statistical components.
• Design a CRF: Demonstrate a solid grasp of Clinical Data Management by creating a functional and intuitive Case Report Form.
• Discuss Clinical Trial Life Cycle Elements: Understand and converse about the regulatory and ethical frameworks, milestones, project execution strategies, and quality management aspects inherent to clinical research.
• Distinguish Between Study Designs: Differentiate the characteristics of observational studies (like descriptive or cross-sectional studies) from experimental studies (like trials). Basics of power and sample size calculation considerations needed in the protocol or research grant application.
• Utilize Clinical Trial Findings: Extract valuable insights from study outcomes, guiding for example policy development.

Public health professionals, epidemiologists, researchers, health policy planners, and health allied professionals interested in clinical study designs and data management.

Registration is Closed.

The Applied Clinical Research (ACR) Course, held from March 24th to 28th, 2025, at the TTU Seminar Room in the Tuerkenstrasse, brought together a diverse group of participants to deepen their understanding of clinical trial design, data analysis, and study management.

Dr. Abhishek Bakuli opened the course with an in-depth session on clinical study designs and statistical aspects, that introduced participants to various observational and experimental studies and how to align them with specific research questions.

Afterwards the focus shifted to protocol development, led by Dr. Norbert Heinrich and Dr. Ivan Noreña. Through collaborative group work, participants refined their skills in defining study objectives, identifying key outcomes, and addressing core methodological considerations.

In the middle of the week, Dr. Noemi Castelletti focused on Case Report Form (CRF) design and data collection. Participants created functional and compliant CRFs. The project management sessions with Dr. Otto Geisenberger and Dr. Anka Mekota addressed the logistical challenges of clinical trial execution.

Another highlight was the Good Clinical Practice (GCP) training led online by Dr. Susanne Vejda, reinforcing ethical and regulatory standards essential to conducting human research.

On the final day, participants sat for the ACR exam and attended a closing lecture by Prof. Dr. Michael Hoelscher on translating clinical research into health policy, an inspiring end to a rigorous and practical week.