Integrity of Scientific Data : Transparency of Clinical Trial Data
Nicholas Moore
(1)
,
Yves Juillet
,
Pierre-Henri Bertoye
,
Christophe Baduel
,
Corinne Bernaud
,
Geneviève Chêne
(2)
,
Dominique Doucet
,
Thérèse Dupin-Spriet
,
Valérie Foltzer
,
Jean-Marie Goehrs
(3)
,
Danielle Golinelli
,
Sylvie Hansel
,
Jean-Marc Husson
(4)
,
Pascale Jolliet
(5)
,
Rémi Lecoent
,
Joël J. Moret-Bailly
(6)
,
François Pelen
,
Yannick Plétan
(7)
,
Catherine Rey-Quino
,
Jean-Charles Reynier
,
Tabassome Simon
(8)
,
Anne-Priscille Vlasto
,
Beat Widler
,
Faiez Zannad
(9)
1
INSERM U657, CIC-P0005, Département de pharmacologie
2 Epidémiologie et Biostatistique [Bordeaux]
3 JM Goehrs Partners
4 European Forum for Good Clinical Practice
5 Service de Pharmacologie Clinique [CHU Nantes]
6 CERCRID - Centre de Recherches Critiques sur le Droit
7 Laboratoire Roche [Boulogne-Billancourt]
8 CHU Saint-Antoine [AP-HP]
9 Service de Cardiologie [CHRU Nancy]
2 Epidémiologie et Biostatistique [Bordeaux]
3 JM Goehrs Partners
4 European Forum for Good Clinical Practice
5 Service de Pharmacologie Clinique [CHU Nantes]
6 CERCRID - Centre de Recherches Critiques sur le Droit
7 Laboratoire Roche [Boulogne-Billancourt]
8 CHU Saint-Antoine [AP-HP]
9 Service de Cardiologie [CHRU Nancy]
Yves Juillet
- Fonction : Auteur
Pierre-Henri Bertoye
- Fonction : Auteur
Christophe Baduel
- Fonction : Auteur
Corinne Bernaud
- Fonction : Auteur
Dominique Doucet
- Fonction : Auteur
Thérèse Dupin-Spriet
- Fonction : Auteur
Valérie Foltzer
- Fonction : Auteur
Danielle Golinelli
- Fonction : Auteur
Sylvie Hansel
- Fonction : Auteur
Pascale Jolliet
- Fonction : Auteur
- PersonId : 785698
- ORCID : 0000-0003-0191-9249
Rémi Lecoent
- Fonction : Auteur
Joël J. Moret-Bailly
- Fonction : Auteur
- PersonId : 756632
- IdRef : 086137972
François Pelen
- Fonction : Auteur
Catherine Rey-Quino
- Fonction : Auteur
Jean-Charles Reynier
- Fonction : Auteur
Tabassome Simon
- Fonction : Auteur
- PersonId : 741176
- IdHAL : tabassome-simon
- ORCID : 0000-0002-4550-0450
- IdRef : 070443122
Anne-Priscille Vlasto
- Fonction : Auteur
Beat Widler
- Fonction : Auteur
Faiez Zannad
- Fonction : Auteur
- PersonId : 756877
- ORCID : 0000-0001-7456-1570
Résumé
The integrity of the data from clinical trials and of its use is an essential element of the scientific method, and of the trust one can have in this method. There are many examples of fraud, and they recur regularly. The objective of this round table was to work on the definition of fraud, on its recognition and prevention especially in the institutional system. Fraud involves an active decision to cheat, and ranges from trying to hide incompetence to wholesale invention of data, patients or studies. Its frequency is difficult to evaluate but might be as high as 1% of all studies or publications. Fraud can involve ethics (post-hoc IRB [institutional review board] approval, IRB requests not applied, lack of consent), or any of the steps from realisation to interpretation of studies or trials. Identification of fraud is made harder by the usual risk for the whistle-blowers, who must be protected. Seeking fraud is implicit in Good Clinical Practices (GCP) that all industry sponsors must apply, but that are less often applied by institutional sponsors. It might be useful to install procedures to detect fraud in studies, especially institutional. Various statistical methods can be used to identify unusual data patterns that could suggest fraud. Once fraud is identified, its management is often not foreseen. Here again, clear procedures or recommendations would be of help.
Domaines
DroitFormat du dépôt | Notice |
---|---|
Type de dépôt | Article dans une revue |
Titre |
en
Integrity of Scientific Data : Transparency of Clinical Trial Data
|
Résumé |
en
The integrity of the data from clinical trials and of its use is an essential element of the scientific method, and of the trust one can have in this method. There are many examples of fraud, and they recur regularly. The objective of this round table was to work on the definition of fraud, on its recognition and prevention especially in the institutional system. Fraud involves an active decision to cheat, and ranges from trying to hide incompetence to wholesale invention of data, patients or studies. Its frequency is difficult to evaluate but might be as high as 1% of all studies or publications. Fraud can involve ethics (post-hoc IRB [institutional review board] approval, IRB requests not applied, lack of consent), or any of the steps from realisation to interpretation of studies or trials. Identification of fraud is made harder by the usual risk for the whistle-blowers, who must be protected. Seeking fraud is implicit in Good Clinical Practices (GCP) that all industry sponsors must apply, but that are less often applied by institutional sponsors. It might be useful to install procedures to detect fraud in studies, especially institutional. Various statistical methods can be used to identify unusual data patterns that could suggest fraud. Once fraud is identified, its management is often not foreseen. Here again, clear procedures or recommendations would be of help.
|
Auteur(s) |
Nicholas Moore
1
, Yves Juillet
, Pierre-Henri Bertoye
, Christophe Baduel
, Corinne Bernaud
, Geneviève Chêne
2
, Dominique Doucet
, Thérèse Dupin-Spriet
, Valérie Foltzer
, Jean-Marie Goehrs
3
, Danielle Golinelli
, Sylvie Hansel
, Jean-Marc Husson
4
, Pascale Jolliet
5
, Rémi Lecoent
, Joël J. Moret-Bailly
6
, François Pelen
, Yannick Plétan
7
, Catherine Rey-Quino
, Jean-Charles Reynier
, Tabassome Simon
8
, Anne-Priscille Vlasto
, Beat Widler
, Faiez Zannad
9
1
INSERM U657, CIC-P0005, Département de pharmacologie
( 259114 )
- Bordeaux
- France
2
Epidémiologie et Biostatistique [Bordeaux]
( 55677 )
- 146, rue Léo-Saignat 33076 Bordeaux
- France
3
JM Goehrs Partners
( 530671 )
- 85 Avenue de Saint-Cloud, 78000 Versailles
- France
4
European Forum for Good Clinical Practice
( 180537 )
- Brussels
- Belgique
5
Service de Pharmacologie Clinique [CHU Nantes]
( 539925 )
- France
6
CERCRID -
Centre de Recherches Critiques sur le Droit
( 3131 )
- 35 rue du 11 novembre 42023 Saint-Étienne cedex 2
- France
7
Laboratoire Roche [Boulogne-Billancourt]
( 355424 )
- 30 Cours de l'Île Seguin, 92100 Boulogne-Billancourt
- France
8
CHU Saint-Antoine [AP-HP]
( 454982 )
- 184, rue du Faubourg Saint-Antoine
75571 Paris cedex 12
- France
9
Service de Cardiologie [CHRU Nancy]
( 44949 )
- France
|
Langue du document |
Anglais
|
Nom de la revue |
|
Vulgarisation |
Non
|
Comité de lecture |
Oui
|
Audience |
Internationale
|
Date de publication |
2007-05
|
Volume |
62
|
Numéro |
3
|
Page/Identifiant |
211-216
|
URL éditeur |
https://www.journal-therapie.org/articles/therapie/pdf/2007/03/th071642.pdf
|
Domaine(s) |
|
Mots-clés |
en
clinical trials, fraud, prevention
|
DOI | 10.2515/therapie:2007043 |
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