Reporting of serious adverse events during cancer clinical trials to the institutional review board: An evaluation by theResearch onAdverseDrug eventsAndReports (RADAR) project

2013 ◽  
Vol 53 (12) ◽  
pp. 1334-1340 ◽  
Author(s):  
S.M. Belknap ◽  
C.H. Georgopoulos ◽  
J. Lagman ◽  
S.A. Weitzman ◽  
L. Qualkenbush ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Institutional Review Board ◽  
Cancer Clinical Trials ◽  
Serious Adverse Events ◽  
Institutional Review

scholarly journals Meeting the Challenge: The National Cancer Institute’s Central Institutional Review Board for Multi-Site Research

2018 ◽  
Vol 36 (8) ◽  
pp. 819-824 ◽  
Author(s):  
Holly A. Massett ◽  
Sharon L. Hampp ◽  
Jacquelyn L. Goldberg ◽  
Margaret Mooney ◽  
Linda K. Parreco ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
The United States ◽  
National Institutes Of Health ◽  
Institutional Review Board ◽  
Cancer Clinical Trials ◽  
Limited Data ◽  
Human Patient ◽  
Institutional Review ◽  
Central Institutional Review Board

The National Institutes of Health (NIH) issued a new policy that requires a single institutional review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs. Since 2001, the National Cancer Institute (NCI) has funded a central IRB (CIRB) that provides human patient reviews for its extensive national cancer clinical trials program. This paper presents data to show the adoption, efficiencies gained, and satisfaction of the CIRB among NCI trial networks and reviews key lessons gleaned from 16 years of experience that may be informative for others charged with implementation of the new NIH single-IRB policy.

Central IRB Review Is an Essential Requirement for Cancer Clinical Trials

2017 ◽  
Vol 45 (3) ◽  
pp. 341-347 ◽  
Author(s):  
Lowell E. Schnipper
Keyword(s):  
Clinical Trials ◽  
Institutional Review Board ◽  
Cancer Clinical Trials ◽  
Essential Requirement ◽  
Institutional Review ◽  
Legal Arguments ◽  
Central Institutional Review Board

There are compelling medical, ethical, and legal arguments that support mandating use of a central institutional review board (CIRB) for the review of clinical trials performed at multiple institutional sites. Progress against serious diseases depends on this.

scholarly journals Assessment of the risk/benefit ratio of phase II cancer clinical trials by Institutional Review Board (IRB) members

2002 ◽  
Vol 13 (8) ◽  
pp. 1307-1313 ◽  
Author(s):  
H.E.M. van Luijn ◽  
A.W. Musschenga ◽  
R.B. Keus ◽  
W.M. Robinson ◽  
N.K. Aaronson
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Institutional Review Board ◽  
Cancer Clinical Trials ◽  
Benefit Ratio ◽  
Institutional Review

Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms

2019 ◽  
pp. 331-340
Author(s):  
Susan Churchill ◽  
◽  
Kayla Deru ◽  
Lindell K. Weaver ◽  
Steffanie H. Wilson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Hyperbaric Oxygen ◽  
Gas Flow ◽  
Randomized Trials ◽  
Symptom Improvement ◽  
Sham Control ◽  
Serious Adverse Events ◽  
Double Blind ◽  
To Receive

Safety monitoring and successful blinding are important features of randomized, blinded clinical trials. We report chamber- and protocol-related adverse events (AEs) for participants enrolled in two randomized, double-blind clinical trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as well as the success of maintaining the blind with a low-pressure sham control arm. In both studies, participants were randomized to receive HBO2 (1.5 atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres absolute, room air). In 143 participants undergoing 4,245 chamber sessions, chamber-related adverse events were rare (1.1% in the HOPPS study, 2.2% in the BIMA study). Minor, non-limiting barotrauma was the most frequently reported. Rarely, some participants experienced headache with chamber sessions. No serious adverse events were associated with chamber sessions. An allocation questionnaire completed after intervention revealed that the sham control arm adequately protected the blind in both trials. Participants based allocation assumptions on symptom improvement or lack of symptom improvement and could not discern intervention arm by pressure, smell, taste, or gas flow.

Inappropriate Grading of Adverse Events in Cancer Clinical Trials

JAMA Oncology ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. 269
Author(s):  
Sheng Zhang ◽  
Hongxi Xue
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Cancer Clinical Trials

scholarly journals 32 Quantifying the Prevalence of Frailty in Drug Trials and the Relationship with Serious Adverse Events

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i7-i11
Author(s):  
P Hanlon ◽  
E Butterly ◽  
J Lewsey ◽  
S Siebert ◽  
F S Mair ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Disease Severity ◽  
Negative Binomial ◽  
Frailty Index ◽  
Chronic Obstructive ◽  
Drug Trials ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Increased Risk

Abstract Introduction Frailty is common in clinical practice, but trials rarely report on participant frailty. Consequently, clinicians and guideline-developers assume frailty is largely absent from trials and have questioned the relevance of trial findings to frail people. Therefore, we examined frailty in phase 3/4 industry-sponsored clinical trials of pharmacological interventions for three exemplar conditions: type 2 diabetes mellitus (T2DM), rheumatoid arthritis (RA), and chronic obstructive pulmonary disease (COPD). Methods We constructed a 40-item frailty index (FI) in 19 clinical trials (7 T2DM, 8 RA, 4 COPD, mean age 42–65 years) using individual-level participant data. Participants with a FI >0.24 were considered “frail”. Baseline disease severity was assessed using HbA1c for T2DM, Disease Activity Score-28 (DAS28) for RA, and % predicted FEV1 for COPD. Using generalised gamma regression, we modelled FI on age, sex and disease severity. In negative binomial regression we modelled serious adverse event rates on FI, and combined results for each index condition in a random-effects meta-analysis. Results All trials included frail participants: prevalence 7–21% in T2DM trials, 33–73% in RA trials, and 15–22% in COPD trials. Increased disease severity and female sex were associated with higher FI in all trials. Frailty was associated with age in T2DM and RA trials, but not in COPD. Across all trials, and after adjusting for age, sex, and disease severity, higher FI predicted increased risk of serious adverse events; the pooled incidence rate ratios (per 0.1-point increase in FI scale) were 1.46 (95% CI 1.21–1.75), 1.45 (1.13–1.87) and 1.99 (1.43–2.76) for T2DM, RA and COPD, respectively. Conclusion Frailty is identifiable and prevalent among middle aged and older participants in phase 3/4 drug trials and has clinically important safety implications. Trial data may be harnessed to better understand chronic disease management in people living with frailty.

scholarly journals Methods for measuring venous peripherally inserted central catheters in newborns

2022 ◽  
Vol 75 (2) ◽  
Author(s):  
Andreia Tomazoni ◽  
Patrícia Kuerten Rocha ◽  
Mavilde da Luz Gonçalves Pedreira ◽  
Elisa da Conceição Rodrigues ◽  
Bruna Figueiredo Manzo ◽  
...  
Keyword(s):  
Adverse Events ◽  
Neonatal Intensive Care ◽  
Descriptive Analysis ◽  
Institutional Review Board ◽  
Central Catheter ◽  
Peripherally Inserted Central Catheters ◽  
Institutional Review ◽  
Significant Difference ◽  
Catheter Tip ◽  
Central Catheters

ABSTRACT Objective: to analyze the results of insertion procedures of Peripherally Inserted Central Catheters in newborns using two measurement methods. Methods: this is a randomized clinical trial, presenting descriptive and exploratory results of variables. It was held at a Neonatal Intensive Care Unit. Data were collected between September 2018 and 2019. The sample analyzed was 88 catheter insertion procedures, distributed in two groups. Study approved by an Institutional Review Board and obtained registration in the country and abroad. Descriptive analysis and logistic regression of data. Results: modified measurement obtained a significant difference for the central catheter tip location. Elective removals and adverse events were not significant between groups; however, poor positioning was related to adverse events. Conclusions: between the two methods analyzed, the modified measurement obtained better results in the proper catheter tip positioning and, consequently, less risk to patients.

Sign in / Sign up

Export Citation Format

Share Document