CoChat
Sign Up
Cited by 73Ethics in Clinical ResearchBiomedical Ethics and RegulationPharmaceutical industry and healthcare

The unintended consequences of clinical trials regulations

Open access
McMahon, Alex D., Conway, David I., MacDonald, Tom M., McInnes, Gordon T.·2009·PLoS Medicine
DOI 10.1371/journal.pmed.1000131PMC PMC2768793
Open this paper in CoChat — free accountOpen PDF

Abstract

Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1371/journal.pmed.1000131

Cites

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Registry data can be analysed to study regional variation, temporal trends, and predictors of patient outcomes; compare propensity score matched patient subgroups receiving different treatments; and gain insights into the implementation of published evidence and guidelines in routine clinical practice.

    “Registry data can be analysed to (1) study regional variation, temporal trends, and predictors of patient outcomes; (2) compare propensity score matched patient subgroups receiving different treatments; and (3) gain insights into the implementation of published evidence and guidelines in routine clinical practice. 316,356,358 361”

    From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [361]

    Split into 3 atoms — 0 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 3 unverifiable. Expand the claim to see per-atom verdicts.

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

The citation lists haven’t been fetched yet

References 32 · Cited by 73

Research works printed but not linked: 30

  1. [1]Stewart PM Stears A Tomlinson JW Brown MJ 2008 Regulation – the real threat to clinical research. BMJ 337 1085 1087 18927171
  2. [3]Baum M Buchanan M Baselga J Cataliotti L Jassem J 2007 The future of breast cancer research in danger. Eur J Can 38 2210 2213 12441256
  3. [4]2001 Directive 2001/20/ EC of the European parliament and of the council of 4 April 2002 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities L121 34 44 Available: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf. Accessed 6 July 2009. 16276663
  4. [5]2004 The Medicines for Human Use (Clinical Trials) Regulations 2004. Available: http://www.opsi.gov.uk/si/si2004/20041031.htm. Accessed 6 July 2009. 15812991
  5. [7]2005 Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. Official Journal of the European Communities L91: 13–19. Available: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2005_28/dir_2005_28_en.pdf. Accessed 6 July 2009.
  6. [13]Anonymous 2003 Who's afraid of the European Clinical Trials Directive? Lancet 361 2167 12842362
  7. [15]Morice AH 2003 The death of academic clinical trials. Lancet 361 1568 12737908
  8. [16]Flavell DJ Flavell SU Sullivan R 2003 European Clinical Trials Directive: responses made to MHRA consultation letter MLX 287. Lancet 3623 1415 14585646
  9. [17]Anon 2004 EU clinical trials directive: 0% inspiration, 100% perspiration? Lancet Neur 3 321 15157844
  10. [18]Meunier F Dubois N Negrouk A Rea LA 2003 Throwing a wrench in the works? Lancet Onc 4 717 718 14662426
  11. [19]Williams N 2004 Breast cancer research and the European Union Clinical Trials Directive. Breast Can Res 6 145 147 PMC468644 15217484
  12. [21]Nundy S Gulhati CM 2005 A new colonialism? Conducting clinical trials in India. N Engl J Med 352 1633 1636 15843665
  13. [22]Woods K 2004 Implementing the European clinical trials directive - Discussions continue in the European Commission and the United Kingdom. BMJ 328 7434 240 241 PMC324443 14751874
  14. [23]Singer EA Mullner M 2002 Implications of the EU directive on clinical trials for emergency medicine - Many trials in emergency medicine will not be possible. BMJ 324 1169 1170 12016168 PMC1123147
  15. [24]Druml C Singer EA 2004 The European Directive: a further blow to science in intensive care medicine in Austria. Inten Care Med 30 335 14685660
  16. [25]Hall JE Diaz-Navarro C 2005 Living with the European Clinical Trials Directive: one year on. Anaesthesia 60 949 951 16179036
  17. [27]Hartmann M Hartmann-Vareilles F 2006 The clinical trials directive: how is it affecting Europe's noncommercial research? PLoS Clin Trials 1 e13 doi: 10.1371/journal.pctr.0010013 16871335 PMC1488897 · DOI
  18. [28]Sinha G 2006 European move affects academic trials research. J Nat Can Inst 98 1100 1101 16912258
  19. [29]Hemminki A Kellokumpu-Lehtinen PL 2006 Harmful impact of EU clinical trials directive - Academic clinical research in cancer seems to have no future in Europe. BMJ 332 501 502 16513690 PMC1388117
  20. [30]Rice M 2006 New data on clinical trials directive in Europe show few favourable outcomes. J Nat Can Inst 98 159 160 16449673
  21. [31]Hanning CD Rentowl P 2006 Harmful impact of EU clinical trials directive - Trial of alerting drug in fibromyalgia has had to be abandoned. BMJ 332 666 PMC1403272 16543347
  22. [32]Watson M 2006 Harmful impact of EU clinical trials directive … and so has trial of melatonin in cancer related weight loss. BMJ 332 666 PMC1403237 16543346
  23. [33]Mitchell CD 2006 Harmful impact of EU clinical trials directive … while paediatric oncology is being scuppered. BMJ 332 666 PMC1403283 16543345
  24. [34]Cannell E 2007 Clinical Trials Directive slows registration of paediatric studies. Lancet Onc 8 10 17348116
  25. [35]Welzing L Harnischmacher U Weyersberg A Roth B 2007 Consequences of Directive 2001/20/EC for investigator-initiated trials in the paediatric population - a field report. Eur J Ped; 166 1169 1176 17333274
  26. [36]Mitchell C 2007 Clinical trials in paediatric haematology-oncology: are future successes threatened by the EU directive on the conduct of clinical trials? Arc Dis Child 92 1024 1027 PMC2083592 17954482
  27. [38]Lehmann B 2008 Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations. Child Adolesc Psychiatry Ment Health 2 37 19063722 PMC2633263
  28. [39]Permanand G Mossialos E McKee M 2007 The EU's new paediatric medicines legislation: serving children's needs? Arc Dis Child 92 808 811 PMC2084007 17715445
  29. [40]Hearn J Sullivan R 2007 The impact of the ‘Clinical Trials’ directive on the cost and conduct of non-commercial cancer trials in the UK. Eur J Can 43 8 13 17118647
  30. [41]Califf RM 2007 Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials 6 496 502 17170032

Authors
McMahon, A. D., Conway, D. I., MacDonald, T. M., & McInnes, G. T.
Affiliations
University of Glasgow (GB)
Corresponding author
McMahon, Alex D.
ORCID
Venue
PLoS Medicine
Publisher
Public Library of Science (PLoS)
Published
2009-11-17
Volume
6
Issue
11
Pages
e1000131
ISSN
  • 1549-1277 (ISSN-L)
  • 1549-1676
DOI
10.1371/journal.pmed.1000131
PMC
PMC2768793
OpenAlex
W2037672565
Cited by
73
References
32
Citations by year
2026: 3 · 2025: 2 · 2024: 1 · 2023: 1 · 2022: 1 · 2021: 8 · 2020: 5 · 2019: 3 · 2018: 1 · 2017: 5 · 2016: 9 · 2015: 6 · 2014: 7 · 2013: 3 · 2012: 6
FWCI
6.05
Type
journal article
Language
en
Open access
Licence
Locations
  • PLoS Medicine (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
  • Discovery Research Portal (University of Dundee) (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Keywords
good clinical practice, clinical trial regulation, randomized controlled trials, regulatory burden, research ethics oversight
MeSH terms
Clinical Trials as Topic, Congresses as Topic, Drug Industry, Europe, Humans, Drug Approval, Practice Guidelines as Topic, Evidence-Based Medicine, Government Regulation

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review