A retrospective look: Industry partnership and transparency in phase III randomized clinical trials of breast cancer targeted therapies across two decades.
Notice bibliographique
Résumé
580 Background: To unveil industry involvement with respect to sponsorship, authorship, and demographic shifts in the trends of randomized clinical trials for breast cancer targeted therapies over the past two decades. Methods: All randomized phase III clinical trials focusing on targeted therapies for breast cancer were systematically identified from clinicaltrials.gov and reviewed using peer-reviewed publications. Trials that focused solely on chemotherapy and hormonal therapy were excluded. SAS Enterprise Guide v7.1 was used to analyze trial characteristics, authorship, and demographic details with Chi-square and Fisher’s exact tests. Results: From 2005-2023, 998 breast cancer treatment clinical trials were identified; 110 trials were included in the final analysis. Overall, 8.2% were limited to the U.S. and Canada while 67.3% were carried out internationally. 34.5% were led by cooperative (Co-op) groups vs 65.5% by pharmaceutical industries. 19.1% of trials were published in the New England Journal of Medicine (NEJM); all NEJM published trials reported positive results and 76.2% of were industry led. In contrast, of the 4.5% of trials featured in The Lancet, only 60% showed positive findings and 60% had major industry sponsorship. The most common industry partnerships were with Roche (27.3%), Novartis (12.7%), and Pfizer (7.3%) while the most common leading Co-op group was the National Cancer Institute (7.3%). To evaluate trends, trials were split into 3 time periods based on publication dates: 2005-2011, 2012-2017, and 2018-2023. The number of trial publications increased from 13 to 43 to 54. Of the 70% of trials that reported race/ethnicity data, the proportion of White patients decreased (84.5%, 78.8%, 79.3%; p<0.001) and the proportion of Asian patients increased (8.9%, 18.4%, 16.7%; p<0.001). However, enrollment of Black (6.6%, 2.8%, 4.0%; p<0.001) and Hispanic (7.0%, 2.8%, 5.0%; p<0.001) patients remained low. There were no statistically significant changes in international participation (46.2%, 69.8%, 70.4%; p=0.22), the proportion of exclusively industry-led (46.2%, 74.4%, 63.0%; p=0.15) or Co-op group-designed trials (61.5%, 35.7%, 26.4%; p=0.10). Industry-involved data collection increased from 23.1% to 64.2% to 73.6% (p=0.01) while industry sponsored data analysis (38.5%, 61.9%, 66.0%; p=0.49) and manuscript drafting (38.5%, 66.7%, 71.7%; p=0.09) did not significantly change. Conclusions: Over time, there was a notable rise in the number of phase III clinical trials for breast cancer targeted therapies. More than 70% of these trials now engage in international collaboration. Despite this progress, there remains an underrepresentation of Black and Hispanic participants in trial enrollment. Today, nearly 70% of trials have major industry sponsorship in study design, data analysis, and manuscript preparation.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,045 | 0,011 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,006 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,002 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,008 | 0,013 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; les deux têtes enseignantes s’accordent sur ce qui est montré ici.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».