Ethics codes and use of new and innovative drugs

@article{Borysowski2019EthicsCA,
  title={Ethics codes and use of new and innovative drugs},
  author={Jan Borysowski and Hans-J{\"o}rg Ehni and Andrzej G{\'o}rski},
  journal={British Journal of Clinical Pharmacology},
  year={2019},
  volume={85},
  pages={501 - 507}
}
Treatment with new and/or innovative drugs with uncertain safety and efficacy profile is associated with substantial ethical concerns. The main objective of this paper is to present guidance on the use of such drugs contained in: (i) major international codes and guidelines pertaining to medical ethics and biomedical research; (ii) national codes of medical ethics and professional conduct of the USA, Canada, Australia, New Zealand, the UK, Ireland, France and Germany. Out of the four… Expand
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References

SHOWING 1-10 OF 51 REFERENCES
Ethics review in compassionate use
TLDR
Approval by a research ethics committee should be obligatory for compassionate use, and aspects of compassionate use that are important for the discussion of the role of research ethics committees in the review are presented. Expand
The ethics of using innovative therapies in the care of children.
TLDR
In paediatrics, the conflict between withholding potential rescue therapy and protecting a vulnerable population's rights and welfare must be considered, and it is necessary to ensure that this innovation is conducted within an ethical framework that recognizes that the therapy is not standard. Expand
Study on off-label use of medicinal products in the European Union.
TLDR
The balance between the benefits and risks that off-label use has for patients, and the regulatory framework for the off- Label use of medicines is investigated, as well as a description of the national frameworks, regulatory and other, governing off- label use of medicinal products in the various EU Member States. Expand
The Ethical Challenges of Compassionate Use.
Granting access to drugs, vaccines, biologics, and devices that have not yet been approved by governmental regulatory authorities is a growing challenge for physicians, public officials, patientExpand
Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans.
TLDR
The aim of the guidelines is to provide internationally vetted ethical principles and detailed commentary on how these principles should be applied, with particular attention to conducting research in lowand middleincome countries (LMICs). Expand
An overview of Compassionate Use Programs in the European Union member states.
TLDR
Overall, this review identified CUP and its current status and legislation in 28 EU member states and suggested their willingness to adopt processes that facilitate earlier and better access to new medicines. Expand
Legal and regulatory responses to innovative treatment.
TLDR
This paper discusses recent developments in Singapore and uses them as a springboard to flesh out basic regulatory issues that arise from the deployment of innovative treatment: the distinction between innovative treatment and clinical research, the adequacy of the current post hoc scrutiny of innovative therapy under existing legal principles and the need for further specialised regulatory oversight. Expand
The need to revise the Helsinki Declaration
TLDR
The Macchiarini case illustrates how the 37th paragraph of the Helsinki Declaration can be misinterpreted, and emphasises the need to revise this part of the declaration to better safeguard against experimentation at the physician's own discretion. Expand
Ten common questions (and their answers) about off-label drug use.
The term off-label drug use (OLDU) is used extensively in the medical literature, continuing medical education exercises, and the media. Yet, we propose that many health care professionals have anExpand
Terminal illness and access to Phase 1 experimental agents, surgeries and devices: reviewing the ethical arguments.
TLDR
The ethical arguments for and against the provision of access to Phase 1 agents for terminally ill patients are reviewed, including questions about the kinds of personal sacrifices society can reasonably expect patients in clinical trials to make to ensure statistically predictive results. Expand
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