386. Participant Reflections on Their Experiences Participating in Phase 1 and 2 Inpatient Vaccine Trials and Human Challenge Studies
Notice bibliographique
Résumé
Abstract Background Volunteers are critical for the success of clinical trials but there is still debate on the ethics surrounding recruitment and enrollment of healthy human subjects who are paid for their participation in such research. This study seeks to examine the experiences and perceptions of risks and benefits of participants in early-phase inpatient studies to gain greater insight into how they feel about participating. Methods An interviewer-administered survey was conducted with 152 healthy volunteers who participated in at least one Phase 1 or 2 inpatient vaccine or challenge clinical trial at the Johns Hopkins Center for Immunization Research, during the years of 2010-2020. Participant characteristics, study experiences, and perceived risks were analyzed. Poisson regression with robust variance was used to examine factors associated with perception of risk before and after participation. Results Most participants who completed the survey were male (62%) and Black or African American (78%). 53% attained at most a high school degree and 42% had an income below $18,500 a year. Compensation was the primary factor for joining a study for 68% of participants; 35% of them relied on clinical trials as a major part of their income. Nevertheless, 32% reported they declined to participate in at least one study and 63% reported that they ask about the side effects before joining a new study. Over 90% of participants agreed or strongly agreed that they enjoyed participating, wanted to participate, and were glad they joined the study. There was a significant reduction in the perceived risk of study participation after study completion compared to perceived risk before joining the study, where before the study 46% thought it was “Not at all risky” compared to 73% afterwards. Conclusion Most participants in our early-phase inpatient studies are males of lower income and compensation was the primary motivator for joining. However, side effects do factor in their decision whether to join. The majority of participants indicated that they were glad they joined the study. Despite the studies having risks and expected side effects, there was also a significant decline in perception of risks related to the study following participation, which implies participants feel safer than they anticipated feeling. Disclosures Lawrence Moulton, PhD, Pfizer Canada ULC: Employee Kawsar R. Talaat, MD, Intralytix: Advisor/Consultant|Merck: Advisor/Consultant|NIAID: DSMB|Pfizer: Grant/Research Support|Pfizer: Pfizer contract with institution|Sanofi: Grant/Research Support|Takeda: Advisor/Consultant
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 | 0,021 | 0,034 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,005 | 0,002 |
| Communication savante | 0,003 | 0,002 |
| Science ouverte | 0,001 | 0,004 |
| Intégrité de la recherche | 0,002 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 0,001 |
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 ».