ReviewBritish journal of clinical pharmacology2019
Ethics codes and use of new and innovative drugs.
Review in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed.
- A Scoping Review of Comparative Healthcare Codes of Ethics Studies.Journal of advanced nursing · 2025Article
- Recent insights on challenges encountered with phage therapy against gastrointestinal-associated infections.Gut pathogens · 2025Review
- Phage Therapy-Challenges, Opportunities and Future Prospects.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Procedures for application of the extended dosing after antitumor drug clinical trials.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2023Article
- Do Physicians Have a Duty to Discuss Expanded Access to Investigational Drugs with their Patients? A Normative Analysis.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2023Article
- Brolucizumab: Evaluation of Compassionate Use of a Complex Anti-VEGF Therapy.Clinical ophthalmology (Auckland, N.Z.) · 2021Article
- Translating Psychedelic Therapies From Clinical Trials to Community Clinics: Building Bridges and Addressing Potential Challenges Ahead.Frontiers in psychiatry · 2021Article
- COVID-19 and off label use of drugs: an ethical viewpoint.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2020Article
- Overcoming Challenges to Make Bacteriophage Therapy Standard Clinical Treatment Practice for Cystic Fibrosis.Frontiers in microbiology · 2020Review
- Reply to "Innovation and off-label use, the French case and more" by Braillon and Lexchin.British journal of clinical pharmacology · 2019Article
- Innovation and off-label use, the French case and more.British journal of clinical pharmacology · 2019Article
- Ethics codes and use of new and innovative drugs.British journal of clinical pharmacology · 2019Review
Corrections and comments
- Commented on by
- Commented on by
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 international codes and guidelines analysed, only the Declaration of Helsinki addresses the question of the use of unproven drugs. Among national codes, only two (USA and New Zealand) explicitly allow for use of new or innovative drugs. Moreover, treatment with unproven drugs seems to be permissible under the French code, though this is not stated explicitly. The remaining codes do not contain any articles on the use of new and innovative drugs. An update of existing articles, as well as the addition of new guidelines to the codes, should be considered in view of the rapid pace of development and introduction to clinical practice of new drugs. This work is relevant to innovative off-label applications of approved drugs and expanded access to investigational drugs.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.