Risultati per: La FDA approva il sistema di riabilitazione dell’ictus

Objective
To examine factors associated with accrual rate in industry sponsored clinical trials supporting US Food and Drug Administration (FDA) cancer drug approvals from 2015 to 2020.

Design, setting and participants
Retrospective cross-sectional study included 194 pivotal trials supporting cancer drug approvals by the US FDA from 2015 to 2020.

Interventions
Clinical trials were analysed for the type of blinding, primary endpoint, whether crossover was specified in the publication, study phase, line of therapy, response rate, investigational sites, manufacturer and randomisation ratio.

Main outcome measures
The main outcome was the rate of accrual, which is the number of patients accrued in the study per open month of enrolment.

Results
The study consisted of 133 randomised (68%) and 61 (32%) non-randomised clinical trials. In randomised studies, we found the accrual rate was higher in trials investigating first and second line drugs (adjusted rate ratios (aRR): 1.55, 95% CI 1.18 to 2.09), phase III trials (aRR: 2.13, 95% CI 1.48 to 2.99), and for studies sponsored by Merck (aRR: 1.47, 95% CI 1.18 to 2.37), adjusting for other covariates. In contrast, the primary endpoint of a study, presence of crossover, single agent response rate, the number of investigational sites, population disease burden and skewed randomisation ratios were not associated with the rate of accrual. In the non-randomised adjusted model, the accrual rate was 2.03 higher (95% CI 1.10 to 3.92) for clinical trials sponsored by manufacturer, specifically Merck. Primary endpoint, crossover, trial phase, response rate, the number of investigational sites, disease burden or line of therapy were not associated with the rate of accrual.

Conclusion
In this cross-sectional study, line of therapy, study phase and manufacturer were the only factors associated with accrual rate. These findings suggest many proffered factors for speedy trial accrual are not associated with greater enrolment rates.

Annals of Internal Medicine, Volume 175, Issue 10, Page JC118, October 2022.

Silvestro Scotti, segretario generale Fimmg, interviene sul tema della possibilità per i medici di famiglia di somministrare i vaccini: «I medici di medicina generale sono stati e continueranno ad essere un punto di riferimento anche per la prossima campagna vaccinale. Contro il Covid, la capillarità dei nostri studi e il rapporto fiduciario che ci lega ai pazienti sono stati elementi essenziali di successo per l’adesione alle vaccinazioni»

This quality improvement study audits individual participant data sharing by pharmaceutical companies for anticancer medicines approved by the US Food and Drug Administration.

In light of the commentary published in Gastroenterology by Goldkind et al,1 we would like to present the comments offered by the Society for the Study of Celiac Disease (SSCD) to the US Food and Drug Administration (FDA) regarding its draft guidance for developing drugs for adjunctive treatment to a gluten-free diet.

The US Food and Drug Administration (FDA) has published the draft guidance “Celiac disease: developing drugs for adjunctive treatment to a gluten-free diet.”1 The guidance intends to promote clinical development of drugs and biologics for the treatment of celiac disease (CeD) as an adjunct to a gluten-free diet (GFD) in adults, based on current understanding of the natural history of the disease. A successful guidance document will promote robust evidence of meaningful benefit and lead to practicable, successful CeD drug development in registered trials that are integral to how patients feel, function, and survive.

Comunicato del 20/09/2021 n°60

Comunicato del 17/07/2021 n°52