Revue de presse – N°11

LogoDMB33Chers adhérents de DMB,

Veuillez trouver ci-dessous la revue de presse n° 11, parution de fin décembre 2013.

Pour rappel : si vous n’êtes pas inscrits sur un des magazines du site www.samedanltd.com, vous pouvez quand-même accéder au moins à la première partie des articles qui donne déjà une bonne idée du contenu. Par contre seuls les abstracts des articles du DIA Journal ‘Therapeutic Innovation & Regulatory Science’ sont accessibles gratuitement.

Nous tenons aussi à vous rappeler que vous êtes invités à participer à la constitution de cette revue en envoyant tout article que vous souhaiteriez partager avec vos co-adhérents à l’adresse mail suivant: carine.javierre.dmb@gmail.com .

DMB vous souhaite une très Bonne Année 2014 et bonne lecture !

Pour l’équipe des contributeurs

Christine Schneider Heyer

Under Surveillance, (Risk-Based Monitoring)

International Clinical Trials, winter 2013

The increasing importance of central statistical surveillance is indicative of the crucial role of statistics and programming in effective clinical trial monitoring. Chitra Lele and Samyuktha Ajay at Sciformix evaluate this risk-based approach.

http://www.samedanltd.com/magazine/13/issue/208/article/3682

Death of CTMS ?  (Trial Management Systems)

International Clinical Trials, winter 2013

The potential demise of clinical trial management systems has been greatly exaggerated. They may have earned a bad reputation in the past but, says Simon Wilson at ArisGlobal, a new generation of these systems has much to offer to clinical operations teams.

http://www.samedanltd.com/magazine/13/issue/208/article/3680

Sponsors Struggle with Data Disclosure Requirements

Applied Clinical Trials, November 2013

Sharing clinical data can improve the efficiency of clinical trials, validate regulatory decisions and increase public confidence in clinical research. But sponsors are concerned about who controls access to data. This article shows controversies between policies and sponsors making efforts to reach consensus on achieving data transparency while enhancing biopharmaceutical innovation.

http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Regulatory+News/Sponsors-Struggle-with-Data-Disclosure-Requirement/ArticleStandard/Article/detail/828036

Jury’s Still Out on How Best to Handle Trial Data The EMA announced the possibility of a delay of their much-awaited guidance on trial data due to the unprecedented response received during public consultation

Applied Clinical Trials, December 2013

The EMA is currently reviewing and analyzing more than 1,000 comments received during the public consultation on its draft policy on trial data, which ran from June to end of September 2013. The Agency has warned that the need to study so many submissions may delay the issuing of a final policy, which was initially planned for the end of 2013.

http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Regulatory+News/Jurys-Still-Out-on-How-Best-to-Handle-Trial-Data/ArticleStandard/Article/detail/830735

People Power, (Data Collection)

International Clinical Trials, winter 2013

Timely, well-planned communication and education goes a long way in helping investigator site staff overcome the growing technology burden stemming from electronic data capture. Caroline Chin and Chuck Johnston from AXON Communications report.

http://www.samedanltd.com/magazine/13/issue/208/article/3683

Does the emerging world still lag behind in EDC adoption?

Applied Clinical Trials, September 2013

The promise of increased efficiencies stemming from EDC has existed for years. However the use of EDC as a standard clinical trial tool in emerging countries is slower than expected. This article explained why and tries to show some solutions to make this change.

http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Articles/Electronic-Data-Capture-in-Clinical-Trials/ArticleStandard/Article/detail/823545

Clinical Trial Design Automation: Incorporating CDISC-based libraries to store study components for study design and building eCRF pages

Applied Clinical Trials, December 2013

There still exists certain phases such as study design and study build within the clinical trial process that can have a significant impact based on reduction in overall time for getting trials ready for study execution across the clinical sites. This article provides a framework called clinical trial design automation that helps establish a recommended approach to manage the study design and study build phase of the overall clinical trial process.

http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Trial+Design+Articles/Clinical-Trial-Design-Automation/ArticleStandard/Article/detail/830736