P-102 The Regulatory and Legal Complexity of the Multicentre, Multinational Clinical Trial with TP05
Notice bibliographique
Résumé
The evidence provided by multinational clinical trials is of outstanding importance for new drugs, new medical devices and new procedures. Large multinational randomised clinical trials are under a financial and organizational threat because of the burden of complex regulations imposed by governments and authorities. The burden is affecting administration, costs and timing. The “overbureaucracy” is justified by protection of data integrity and by protection of the safety of patients. In most of the cases, it is only possible for the industry to manage these trials with the help of CROs (contract research organization). Some authors speak of “mountains of red tape” or “stifled innovation” and “mountains of paperwork” when addressing clinical trial bureaucracy. A quantitative review the paperwork of a major multinational, multicenter clinical trial has to our knowledge not yet been performed. All agreements, contracts and permits necessary for the clinical trial “TP05 for the Treatment of Mild to Moderate Active UC (Precision-UC)” with the Clinicaltrials.gov Identifier: NCT01903252 were analyzed. The number of countries originally approached was 34, covering all continents, with 22 countries in Europe and North America finally participating. The planned number of patients is 800. There are around 180 investigators participating. We looked at investigators, CROs, free-lancers, hospitals, pharmacies, patients, governments, regulatory agencies, IRBs, transport and logistics companies, manufacturer and others. If identified as a legal or regulatory requirement, any legal document or permit became a counting unit. The statistics are descriptive only. Until end of March 2015 we identified 1789 contracts and agreements between the CRO and the sites (64 were in countries which in the end did not participate), 58 contracts between the CRO and subcontractors, 32 contracts of the sponsor (main one with the CRO), 104 permits issued by authorities and institutions, and 3 agreements with couriers and depots. A multinational, multicenter clinical trial of this size requires around 2000 contracts, agreements and permits with a ratio of 1:10 per investigator and 1:2.5 per patient. This amount can only be handled with dedicated legal and administrative support. This also explains why the industry cannot manage such trials without specialized CROs and it also explains why these kinds of trials almost never can be handled purely by the academic community. To minimize the bureaucratic burden, contracts should be rigorously standardized and IRBs as wells as competent authorities should reciprocally acknowledge votes. Absent such steps, there is not much opportunity for improvement to the status quo.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,129 | 0,356 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,001 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,002 | 0,006 |
| Études des sciences et des technologies | 0,001 | 0,005 |
| Communication savante | 0,008 | 0,006 |
| Science ouverte | 0,002 | 0,002 |
| Intégrité de la recherche | 0,003 | 0,006 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,050 | 0,006 |
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; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».