Evidence map›Paper›PMID 30233356›Full record

ArticleFrontiers in pharmacology2018

The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams.

Sandor Kerpel-Fronius, Sander Becker, Jane Barrett, Johan Brun, Roberto Carlesi, Anthony Chan, Luis F Collia, Dominique J Dubois, Peter Kleist, Greg Koski and 4 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact, top 87% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 12 institutions in 10 countries.

Sandor Kerpel-FroniusDepartment of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary.
Sander BeckerPharmaceutical Medicine, Dover Heights, NSW, Australia.
Jane BarrettPharmaceutical Medicine, Cheshire, United Kingdom.
Johan BrunLife Science, Pfizer, Stockholm, Sweden.
Roberto CarlesiIndependent Researcher, Bellagio, Italy.
Anthony ChanPfizer Healthcare Ireland, Dublin, Ireland.
Luis F ColliaCraveri Pharma, Buenos Aires, Argentina.
Dominique J DuboisPHARMED Post-Graduate Programme in Pharmaceutical Medicine and Medicines Development Sciences, Université Libre de Bruxelles, Brussels, Belgium.
Peter KleistCantonal Ethics Committee, Zurich, Switzerland.
Greg KoskiAlliance for Clinical Research Excellence and Safety, Harvard Medical School, Boston, MA, United States.
Chieko KuriharaQuality Assurance and Audit Office, National Institute of Radiological Sciences, National Institute for Quantum and Radiological Science and Technology, Chiba, Japan.
Luis F LaranjeiraAMPIF, Medical Department, Eli Lilly & Co., Lisbon, Portugal.
Johanna SchenkPPH plus GmbH & Co. KG, Hochheim am Main, Germany.
Honorio SilvaIFAPP Academy, New York, NY, United States.
Alliance for Clinical Trials in Oncology · USCheshire West and Chester · GBEli Lilly (United States) · USLeo Pharma (Australia) · AUNational Institutes for Quantum and Radiological Science and Technology · JPNetApp (United States) · USOspedale Bellaria · ITPfizer (Ireland) · IEPfizer (Sweden) · SEPower Plus Communications (Germany) · DESemmelweis University · HUUniversité Libre de Bruxelles · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The complexity of developing and applying increasingly sophisticated new medicinal products has led to the participation of many non-medically qualified scientists in multi-disciplinary non-clinical and clinical drug development teams world-wide. In this introductory paper to the "IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists" it is argued that all members of such multidisciplinary teams must share the scientific and ethical responsibilities since they all influence directly or indirectly both the outcome of the various phases of the medicines development projects and the safety of the research subjects involved. The participating medical practitioner retains the overriding responsibility and the final decision to stop a trial if the well-being of the research subjects is seriously endangered. All the team members should follow the main ethical principles governing human research, the respect for autonomy, justice, beneficence and non-maleficence. Nevertheless, the weighing of these principles might be different under various conditions according to the specialty of the members.

Indexed as

ethicsethics committeemedicines developmentmultidisciplinary researchpharmaceutical medicine

Identifiers

PMID30233356
PMCPMC6130227
OpenAlexW2889186868

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.