spacer
home > ict > summer 2007 > image conscious
PUBLICATIONS
International Clinical Trials

Image Conscious

In adopting a medical imaging strategy, Gunter Bellaire of Perceptive Informatics assesses the potential variability of imaging data collected in multicentre trials, and the variability introduced when interpreting that data

Imaging modalities such as computer tomography (CT) and magnetic resonance imaging (MRI) can provide insight into drug efficacy and safety in a non-invasive way that often provides a faster way to reach traditional clinical endpoints (1).

In the past, even for pivotal studies, only site assessments of imaging data (local image review) were taken into account for study result analysis. However, in recent years, the value of a centralised imaging review has been acknowledged and continues to grow in popularity, making it now the method of choice, particularly for pivotal studies (2). In particular, the standardisation of image acquisition, and independence from clinical patient information, supports the objectivity of image analysis.

The independent centralised review (ICR) process aims for the reproducible outcome of expert image review (3,4). There are ways to assess reproducibility, such as comparing the variability among multiple expert reviewers, or looking at the variability of a single reviewer over time. The features of the central review that contribute to reproducibility are: standardised image acquisition; site and reviewer training; and tools to support the review process. This articles focuses on these aspects and discusses the potential effects attributed to each one.

STANDARDISED IMAGE ACQUISITION

Imaging modalities nowadays are highly complicated devices with various degrees of functioning/flexibility. The overall imaging modalities of choice are usually defined in the study protocol. In a multicentre clinical trial, the local imaging standards and the variety of available modality generations and individual software packages (5), which are defined for local usage, require a considered decision to provide guidance for image acquisition that meets the needs of such a trial.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Gunter Bellaire, PhD, is the Director of Operations at Perceptive Informatics (a PAREXEL International Company), based in the Berlin office for worldwide medical imaging operations. Before taking his post as Director of Operations, Gunter led the EU Perceptive Operations for medical imaging, interactive voice response systems and web solutions. Prior to joining Perceptive in June 2002, he was CTO at MedliveTV. Gunter has also worked as a Senior IT Manager for companies dealing with electronic patient records, medical portals, integrated hospital, and GP information systems.
spacer
Gunter Bellaire, PhD
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Registration Opens for Inaugural HPAPI USA Conference in October

The HPAPI global market is growing at an ever-increasing rate of CAGR at 8.6% that is projected to reach USD $31.56 Billion by 2025, with a significant segment market of HPAPI being oncology ADC which is at a CARG of a staggering 20%. The continual elevation of HPAPI potencies along with toxicity will further drive the needs for more cutting-edge containment solutions and best practices guidelines to ensure workers safety.
More info >>

White Papers

Changing Structural Landscape for Comparator Drug Supply

ADAllen Pharma

TransCelerate Biopharma is focused on advancing innovation in R&D, identifying and solving common R&D challenges and further improving patient safety, with the goal of delivering more high quality medicines to patients. In 2013, they announced its Clinical Trial Comparator Network initiative to show a mutual commitment to offer secure and rapid supply of comparator drug products. The aim of this article is to unpack the section on 'Comparator Drugs' and analyse the rationale for attempting to achieve their objectives.
More info >>

 
Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement