Health Canada’s Use of its Notice of Compliance With Conditions Drug Approval Policy: A Retrospective Cohort Analysis

2018 ◽  
Vol 49 (2) ◽  
pp. 294-305 ◽  
Author(s):  
Joel Lexchin
Keyword(s):  
Median Time ◽  
Retrospective Cohort ◽  
Cohort Analysis ◽  
Drug Approval ◽  
New Drugs ◽  
Approval Process ◽  
Retrospective Cohort Analysis ◽  
Therapeutic Gain ◽  
Post Market ◽  
Health Canada

Health Canada has developed its Notice of Compliance with conditions (NOC/c) policy to get promising new drugs for serious diseases to market faster than would be possible through its standard approval process. Companies can receive an NOC/c for a new drug or a new indication based on incomplete evidence in return for agreeing to conduct post-market studies. This paper investigates the additional therapeutic gain from drugs approved under this policy, the percent of drugs that have fulfilled their conditions, and the length of time for fulfillment. From the inception of the policy in 1998 to the end of 2017, 89 new drugs and new indications for existing drugs received an NOC/c. Therapeutic evaluations were available for 78 of the drugs, and 54 offered only minimal or no gains over existing products. Fifty NOC/c were fulfilled, 31 were not fulfilled, and 8 were withdrawn. The median time to fulfillment was 1,040 days. Twelve NOC/c took more than 5 years to fulfill their conditions. The unfulfilled NOC/c had been issued for a median of 1,161 days, and 10 had been issued more than 5 years. The value of the NOC/c policy to patients is uncertain.

scholarly journals Safety and effectiveness of an all-oral, bedaquiline-based, shorter treatment regimen for rifampicin-resistant tuberculosis in high HIV burden rural South Africa: a retrospective cohort analysis

2020 ◽  
Author(s):  
Ilse Tack ◽  
Asnake Dumicho ◽  
Liesbet Ohler ◽  
Altynay Shigayeva ◽  
Abera Balcha Bulti ◽  
...  
Keyword(s):  
South Africa ◽  
Treatment Regimen ◽  
Median Time ◽  
Retrospective Cohort ◽  
Cohort Analysis ◽  
Treatment Success ◽  
Severe Anaemia ◽  
Rural Setting ◽  
Resistant Tuberculosis ◽  
Retrospective Cohort Analysis

Abstract Background At the end of 2018, South Africa updated its all-oral regimen, to include bedaquiline (BDQ) and two months of linezolid (LZD) for all patients initiating the shorter 9 to 12 months regimen for rifampicin-resistant tuberculosis (RR-TB). We assessed a group of patients in rural KwaZulu-Natal for safety and effectiveness of this treatment regimen under programmatic conditions. Methods We conducted a retrospective cohort analysis on RR-TB patients treated with a standardized all-oral short regimen between July 1, 2018 and April 30, 2019 in three facilities in King Cetshwayo District. An electronic register (EDR Web) and facility-based clinical charts were used to collect variables which were entered into an Epi-Info database. Results Our cohort included 117 patients; 68.4%(95%CI:59.3-76.3) were HIV positive. The median time to culture conversion was 56 days(95%CI:50-57). Treatment success was achieved in 75.2%(95%CI:66.5-82.3) of patients. Mortality within the cohort was 12.8%(95%CI:7.8-20.3). Anaemia was the most frequent severe adverse event. The median time to develop severe anaemia was 7.1 weeks(IQR 4.0-12.9) after treatment initiation. LZD was interrupted in 25.2%(95%CI:17.8-34.5) of participants. Conclusions An all-oral shorter regimen, including BDQ and LZD as core drugs for the treatment of RR-TB, shows good outcomes, in a high HIV burden rural setting. Adverse events (AEs) are common, especially for LZD, but could be managed in the program setting. Support is needed when introducing new regimens to upskill staff in the monitoring, management and reporting of AEs.

Are perceptual disorder signs in diplegic cerebral palsied children stable over time? A retrospective cohort analysis

2020 ◽  
Vol 72 (2) ◽  
Author(s):  
Silvia Alboresi ◽  
Alice Sghedoni ◽  
Giulia Borelli ◽  
Stefania Costi ◽  
Laura Beccani ◽  
...  
Keyword(s):  
Retrospective Cohort ◽  
Cohort Analysis ◽  
Retrospective Cohort Analysis ◽  
Over Time

Preeclampsia and low sodium: a retrospective cohort analysis and literature review

2020 ◽  
Author(s):  
Serena Xodo ◽  
Fabiana Cecchini ◽  
Lisa Celante ◽  
Alice Novak ◽  
Emma Rossetti ◽  
...  
Keyword(s):  
Literature Review ◽  
Retrospective Cohort ◽  
Cohort Analysis ◽  
Low Sodium ◽  
Retrospective Cohort Analysis

scholarly journals Does Time-to-Chemotherapy after Primary Complete Macroscopic Cytoreductive Surgery Influence Prognosis for Patients with Epithelial Ovarian Cancer? A Study of the FRANCOGYN Group

2021 ◽  
Vol 10 (5) ◽  
pp. 1058
Author(s):  
Grégoire Rocher ◽  
Thomas Gaillard ◽  
Catherine Uzan ◽  
Pierre Collinet ◽  
Pierre-Adrien Bolze ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Cytoreductive Surgery ◽  
Retrospective Cohort ◽  
Early Stage ◽  
Cohort Analysis ◽  
Recurrence Free Survival ◽  
Advanced Stage ◽  
Free Survival ◽  
Retrospective Cohort Analysis

To determine if the time-to-chemotherapy (TTC) after primary macroscopic complete cytoreductive surgery (CRS) influences recurrence-free survival (RFS) and overall survival (OS) in patients with epithelial ovarian cancer (EOC). We conducted an observational multicenter retrospective cohort analysis of women with EOC treated from September 2006 to November 2016 in nine institutions in France (FRANCOGYN research group) with maintained EOC databases. We included women with EOC (all FIGO stages) who underwent primary complete macroscopic CRS prior to platinum-based adjuvant chemotherapy. Two hundred thirty-three patients were included: 73 (31.3%) in the early-stage group (ESG) (FIGO I-II), and 160 (68.7%) in the advanced-stage group (ASG) (FIGO III-IV). Median TTC was 43 days (36–56). The median OS was 77.2 months (65.9–106.6). OS was lower in the ASG when TTC exceeded 8 weeks (70.5 vs. 59.3 months, p = 0.04). No impact on OS was found when TTC was below or above 6 weeks (78.5 and 66.8 months, respectively, p = 0.25). In the whole population, TTC had no impact on RFS or OS. None of the factors studied were associated with an increase in TTC. Chemotherapy should be initiated as soon as possible after CRS. A TTC greater than 8 weeks is associated with poorer OS in patients with advanced stage EOC.

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