📢 Early bird deadline EXTENDED 16 January 2024 31 January 2024. Register now

ICC Sydney

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Clinical Trial Governance and Conduct — Ethics, Trial Registration, and Reporting Guideline

Session outline

The Ethical Conduct and Reporting of Clinical Trials Workshop aims to provide participants with a comprehensive understanding of the ethical principles and guidelines associated with conducting clinical trials in rehabilitation sciences. Through a combination of interactive sessions, presentations, and live online interactions, participants will gain knowledge on best practices, relevant guidelines, and the importance of prospective registration and reporting in clinical trial governance.

Workshop Outline:

  1. Introduction and Pre-Workshop Poll (15 minutes)
    • Online Pre-Workshop Poll ( Using Pollseverywhere)
    • Definition of clinical trials according to the World Health Organization (WHO)
    • Evolution of clinical research and the emphasis on ethics and transparency
  2. Ethical Considerations in Clinical Trials (30 minutes)
    • Importance of full-informed consent and protection of human subjects
    • Addressing ethical aspects such as placebo use, risk analysis, post-trial care, and compensation
    • Evidence of breaches and unethical behavior in clinical trial conduct and reporting
  3. Identifying and Implementing Ethical Guidelines (40 minutes)
    • Understanding global standards of ethics in clinical trial conduct and reporting
    • Identifying and applying relevant guidelines to different types of clinical trials
    • Best practices for ethical research and reporting in rehabilitation sciences
  4. Prospective Registration of Clinical Trials (20 minutes)
    • Significance of prospective registration in trial governance
    • Introduction to publicly accessible clinical trial registries
    • Identifying and understanding the function of relevant trial registries
  5. Reporting Guidelines and Publication (30 minutes)
    • Overview of reporting guidelines recommended for clinical trial conduct and publication
    • Mandatory requirements for publication, particularly for randomized controlled trials (RCTs)
    • Compliance with reporting guidelines outlined by the International Committee of Medical Journal Editors (ICMJE)
  6. Hands-on Exercises and Case Studies (60 minutes)
    • Practical exercises to apply ethical principles and guidelines
    • Analyzing case studies to explore ethical dilemmas and decision-making processes.
  7. Interactive Discussions and Q&A (30 minutes)
    • Live online interactions to foster discussion, address participant questions, and share insights
    • Recap of key takeaways and recommendations for further learning and application

The Ethical Conduct and Reporting of Clinical Trials Workshop will equip participants with a solid understanding of ethical principles, relevant guidelines, and the procedures for conducting and reporting clinical trials in rehabilitation sciences. By emphasizing interactive learning and practical exercises, the workshop aims to empower participants to adhere to global ethical standards and contribute to the advancement of ethical clinical research.

Learning outcomes

This workshop is beneficial for healthcare professionals, including physicians and rehabilitation specialists, who are currently involved or plan to conduct clinical trials in rehabilitation medicine.

Target audience

  1. Understand the principles and importance of ethical considerations in clinical trial governance: Participants will gain a comprehensive understanding of the ethical guidelines involved in conducting clinical trials, including the protection of human subjects and informed consent.
  2. Familiarize with trial registration requirements and its significance: Learners will become familiar with the importance of trial registration and its impact on transparency, scientific integrity, and evidence-based medicine.
  3. Explore reporting guidelines for clinical trials: Participants will learn about widely recognized reporting guidelines, such as CONSORT and SPIRIT, to improve the quality of published clinical trial reports.
  4. Apply acquired knowledge to improve clinical trial practices: Participants will develop practical skills in designing ethically sound protocols and implementing appropriate trial registration processes to enhance the overall quality and transparency of clinical trial conduct.

By achieving these learning objectives, participants will be equipped with the knowledge, skills, and ethical awareness necessary to navigate the complex landscape of clinical trial governance and conduct, ultimately contributing to the advancement of ethical research and evidence-based medicine.