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Related Concept Videos

Ethical Standards I01:25

Ethical Standards I

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The American Nurses Association (ANA) created and implemented the first nationally accepted Code of Ethics for Nurses with Interpretive Statements. The Code of Ethics is a living document regularly updated by the ANA and establishes an ethical standard that is non-negotiable for nurses in all roles and settings.
The Code of Ethics provisions outline the nurse's duty to the patient, the healthcare team, the profession, and society. The Code's fundamental principles include advocacy,...
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Ethical Standards II01:23

Ethical Standards II

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Ethical standards are the backbone of nursing practice, guiding nurses as they interact with patients, families, and colleagues. These standards are crucial for providing safe, empathetic care centered on the patient's needs.
Nurses are entrusted with upholding various ethical principles and standards. Nurses forge solid therapeutic relationships using trust, empathy, autonomy, confidentiality, and professional competence.
Confidentiality is crucial, embodying respect for individual privacy...
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Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Ethics in Research01:56

Ethics in Research

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Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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Generation of Comprehensive Thoracic Oncology Database - Tool for Translational Research
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[Clinical research: who owns the data?]

Carly van der Beek1, Adam F Cohen2,3

  • 1Vondst advocaten, Amsterdam.

Nederlands Tijdschrift Voor Geneeskunde
|October 26, 2023
PubMed
Summary

Clinical trial data are facts, but resulting knowledge can be proprietary. Contractual agreements in the Netherlands aim to balance commercial interests with scientific publication needs, though practical loopholes exist.

Area of Science:

  • Medical research ethics
  • Intellectual property in science
  • Clinical trial data management

Context:

  • Clinical trials involving medicines and devices often involve collaborations between academic researchers and commercial entities.
  • This collaboration can create a conflict between the company's desire to protect proprietary knowledge (e.g., for patents) and the scientist's need for timely publication.

Purpose:

  • To explore the inherent tension between commercial interests and scientific dissemination in collaborative clinical research.
  • To examine how contractual agreements in the Netherlands attempt to resolve these conflicts.
  • To identify and discuss practical loopholes in these agreements.

Summary:

  • Clinical trial data itself is factual and unownable, but the derived knowledge holds commercial value and can be proprietary.

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  • Dutch law utilizes contractual agreements to define the relationship between commercial companies and medical centers in research.
  • Despite theoretical frameworks, practical challenges and loopholes persist in managing intellectual property and publication rights.

    • Impact:

    • Highlights the complexities of intellectual property and knowledge sharing in pharmaceutical and medical device research.
    • Informs the development of more robust contractual frameworks for industry-sponsored clinical trials.
    • Underscores the importance of addressing practical discrepancies between legal agreements and research realities.