Protecting intellectual property associated with health technology trials – another barrier to multi-centre trials?
Notice bibliographique
Résumé
To examine the approaches to protection of intellectual property in multi-centre trials currently being conducted in Canada. Two ongoing international multicentre perinatal trials, both funded by the Canadian Institutes of Health Research, were selected for study on the basis of their contrasting approaches to protecting intellectual property. These approaches were examined in detail to understand their motivation, and to estimate the impact of these approaches on centre recruitment. CHIPS (Control of Hypertension in Pregnancy Study, ISRCTN71416914) – is recruiting 1028 pregnant women in 14 countries. Women with hypertension are randomised to tight or less tight control of hypertension. Primary outcome: composite of pregnancy loss/neonatal intensive care. Intellectual property is safeguarded by publishing the protocol online [ 1 ]. Positive consequences: possible/actual sites have easy access to full study design; potential for open discussion between collaborators; study investigators will be held to high standards of reporting. Negative consequences: details are available with potential for plagiarism. FACT (Folic Acid Clinical Trial, ISRCTN23781770) – is recruiting 3656 pregnant women in 4 countries. Pregnant women are randomised to receive either 4 mg folic acid or placebo daily. Primary outcome: development of pre-eclampsia. Intellectual property is safeguarded by requiring local investigators/institutions to sign non-disclosure agreements (NDAs) before the full protocol is provided. Positive consequences: details of the study not available unless legal agreement is signed. Negative consequences: may restrict academic openness; provide additional barriers to site recruitment; investigators may present selected results. The two trials illustrate contrasting approaches to protecting intellectual property associated with study design. This issue is becoming more important for academic institutions whose reputations and wealth are influenced by ownership and management of the intellectual property generated by faculty members. Some institutions prefer to manage risk using legal measures. In the case of trials, institutions protect their intellectual property by introducing NDAs into the sub-site agreement process. NDAs between the lead institution and sub-sites may represent a legally responsible approach. Unfortunately there are potential disadvantages: adding an extra legal step into sub-site recruitment will make this process more difficult; this step may reduce academic openness and collegiality; and restricting the availability of the protocol could allow investigators to present selected results. The use of non-disclosure agreements is an increasing trend in Canada. This trend will impact on the work of clinical trialists, perhaps making site recruitment even more difficult.
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 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 | 0,049 | 0,145 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 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 ».