Revue de Presse – N°12


Revue de presse N° 12

Chers adhérents de DMB,

Veuillez trouver ci-dessous la revue de presse n° 12, parution de fin avril 2014.

Pour rappel : si vous n’êtes pas inscrits sur un des magazines du site, 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: .

DMB vous souhaite une bonne lecture !

Pour l’équipe des contributeurs

Christine Schneider Heyer

FDA, Sponsors Continue Quest for More Efficient Trials
Applied Clinical Trials, February 2014

The decline in important new medicines reaching market in 2013 has produced multiple proposals for making clinical trials more effective and efficient. One of the last recommendations comes from FDA, through a new guidance describing the « Qualification Process for Drug Development Tools » (DDT).

Beyond the Body Shop: How CROs Can Stay Relevant in a Saturated Market
Applied Clinical Trials, Mar 6th 2014 (Blog)

Reducing costs and optimizing clinical trials management should be supported by CROs more and more in competition. The trend is to adapt to the pharmaceutical industry market by specializing in different areas like efficient IT solution for data collection, management and analysis.

Time to Embrace Risk-Based Monitoring

Applied Clinical Trials, Jan 15th 2014 (Blog)

The use of RBM technology to reduce costs and focus on risks, opens a new way of tracking critical data and enhance patient safety.

Vital Statistics, (Risk-Based Monitoring)
International Clinical Trials, winter 2014

Increasingly favored by regulators, central statistical monitoring can better interrogate study data, identifying anomalies early while also minimizing risks and costs. Little wonder, says Marc Buyse at CluePoints, that it looks set to overtake traditional site-based practices.

Personal Touch, (Patient Engagement)
International Clinical Trials, winter 2014

‘Bring your own device’ technology is the next step for pharma as it continues to harness mobile and digital platforms to enhance patient engagement and adherence in trials. Judith Teall at Exco InTouch explores how familiarity breeds success.

Rare Insights , (E-Patient Engagement)
International Clinical Trials, spring 2014

Information on the location and prevalence of people with rare diseases is often hard to come by, but e-patient data and online analytics can provide granular insights that enable more targeted trials. Pete Chan of Tudor Reilly Health reports.

Transparency Impact, (Data Disclosure)
International Clinical Trials, spring 2014

Opening the door to greater trial transparency will help drive clinical R&D and build trust. But, as Mathias Poensgen, Jessica Schell and Simon Wilson at ArisGlobal explain, pharma must also be alert to the implications of too much patient-level data being disclosed.

A Data-Driven Approach to Risk-Based Source Data Verification
Therapeutic Innovation & Regulatory Science, March 2014

Data from 30 eCRF studies conducted between 2005 and 2010 have been analyzed to understand the risks and benefits of specific reduced SDV scenarios. The methodological approach was based upon the 2010 paper published in the Drug Information Journal by Tantsyura et al.. 5 different SDV scenarios are described: 100% SDV, Random SDV, Declining SDV, 3 tiered, Mixed and 3 metrics have been used: % Critical queries found,% Noncritical queries found and % Savings on pages screened. The mixed approach is the more promising scenario that has the potential to be widely used.
The results of this paper demonstrate that data from historical studies can be used to simulate different reduced SDV scenarios.

Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act
Contemporary Clinical Trials, March 2014

As we all know the full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data even redo analysis to challenge trials published results. The legislation seems to be the only way to enforce disclosure of results as currently regulatory system and publishers rely on trial sponsors (academics or industrials) for complete and accurate reporting of results. However, there are still major concerns with participants’ privacy and intellectual property protection of clinical trial results.

Cloud Computing in a GxP Environment: The Promise, the Reality and the Path to Clarityby the GAMP Cloud Computing Special Interest Group (SIG)
Pharmaceutical Engineering, January/February 2014

This article presents the current issues facing adoption of cloud computing, paradigm shifted needed and a strategy for establishing guidance within the pharmaceutical industry.

White Paper

The Role of the CRO in Effective Risk-Based Monitoring – Medpace

The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging trial sponsors to transition from a focused on-site monitoring approach they have traditionally employed toward a risk-based approach that utilizes a combination of centralized and on-site monitoring techniques to ensure patient safety and data quality. The Risk-Based Monitoring (RBM) paradigm has many potential advantages over established monitoring practices including enhanced patient safety and data integrity, more efficient and effective protocol design, reduced costs, and the ability to strategically adjust oversight in keeping with changes in risk level.–medpace