Why industry should register and disclose results of clinical studies—perspective of a recovering academic
Notice bibliographique
Résumé
Why industry should register and disclose results of clinical studies-perspective of a recovering academicJesse A Berlin Although it's not typical, in a scholarly publication such as the BMJ, to add a personal perspective to a commentary, I believe that in this situation my background is relevant to the discussion.My doctoral dissertation, written in 1988, dealt with the topic of publication bias, which was well described in the Ottawa statement appearing in this issue.1 Since then, I've contributed to several studies of factors affecting publication, including an early empirical demonstration of publication bias. 2 About six months ago, I moved from a university, where I had spent 15 years, to a position in a large pharmaceutical research and development group.Registration and disclosure of the results of clinical studies have, not surprisingly, been topics of numerous conversations where I work.At this point, as suggested in the Ottawa statement, there is no longer any doubt that studies, whether sponsored by pharmaceutical companies or otherwise, will be registered and their results will be disclosed.This must be viewed as an overall positive step.The debate has changed focus from whether the research process will become more transparent, to how to carry out registration and disclosure.In the long run, openness of the research process will be good for patients, their families, their caregivers, and ultimately for business.The key area of disagreement between industry positions 3 4 and other proposals relates to the scope of registries.Specifically, the issue is whether all early phase, exploratory studies, or those not testing hypotheses, require registration and disclosure.As noted in the Ottawa statement, the industry position is that results from exploratory studies may be provided if the results are regarded as "medically important," and the results could change the labelling of products.Furthermore, results from failed investigational compounds may also be provided if medically important.Clearly, the definition of "medically important" is both crucial to this discussion and subjective in nature.A key component of the interpretation at Johnson & Johnson Pharmaceutical Research and Development is whether the results indicate harm or lack of efficacy, in which case we will disclose results.We would not rely on results of uncontrolled studies in support of efficacy, but when there is suggestion of harm, we have an obligation at our company to report that information.We believe this approach is consistent with the spirit of the Ottawa statement.What about the question of ethical obligations to research participants?Clearly, we owe our research participants a huge debt.Does that debt extend to full public disclosure of small, uncontrolled studies?By no means am I arguing against disclosure.However, as scientists, we are all aware of the difficulty in interpreting results of small, uncontrolled studies.Even with larger, well controlled studies, there is potential for individual study results to conflict with each other or Gregory J. Lectures on the duties and qualifications of a physician.
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 | 0,052 | 0,264 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,002 | 0,003 |
| Études des sciences et des technologies | 0,013 | 0,017 |
| Communication savante | 0,014 | 0,021 |
| Science ouverte | 0,005 | 0,007 |
| Intégrité de la recherche | 0,107 | 0,106 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,008 | 0,007 |
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 ».