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Rheumatology, Clinical Data Quality, Osteoarthritis
8. Oct 2019

Effect of Intra-Articular Sprifermin vs Placebo on Femorotibial Joint Cartilage Thickness in Patients With Osteoarthritis: The FORWARD Randomized Clinical Trial.

IMPORTANCE:
Sprifermin is under investigation as a disease-modifying osteoarthritis drug.

OBJECTIVE:
To evaluate the effects of sprifermin on changes in total femorotibial joint cartilage thickness in the more symptomatic knee of patients with osteoarthritis.

DESIGN, SETTING, AND PARTICIPANT…

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Authors:

  • Hochberg MC,
  • Guermazi A,
  • Guehring H,
  • Aydemir A,
  • Wax S,
  • Fleuranceau-Morel P,
  • Reinstrup Bihlet A,
  • Byrjalsen I,
  • Ragnar Andersen J,
  • Eckstein F,
Rheumatology, Osteoarthritis, Clinical Data Quality
9. Jan 2018

Gender Differences in Knee Joint Congruity Quantified from MRI: A Validation Study with Data from Center for Clinical and Basic Research and Osteoarthritis Initiative.

Objective Gender is a risk factor in the onset of osteoarthritis (OA). The aim of the study was to investigate gender differences in contact area (CA) and congruity index (CI) in the medial tibiofemoral (MTF) joint in 2 different cohorts, quantified automatically from magnetic resonance imaging (MRI…

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Clinical Data Quality
4. Jan 2016

The impact of clinical trial monitoring approaches on data integrity and cost-a review of current literature

PURPOSE:
Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview o…

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Clinical Data Quality
1. Apr 2015

Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials

AIM:
The aim of this project was to perform an empirical evaluation of the impact of on site source data verification (SDV) on the data quality in a clinical trial database to guide an informed decision on selection of the monitoring approach.

METHODS:
We used data from three randomized phase I…

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Clinical Data Quality
19. Oct 2014

Impact of Source Data Verification on data quality in clinical trials: An empirical post-hoc analysis of three phase 3 randomised clinical trials

AIM:
The aim of this project was to perform an empirical evaluation of the impact of on site source data verification (SDV) on the data quality in a clinical trial database to guide an informed decision on selection of the monitoring approach.

METHODS:
We used data from three randomized phase I…

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