Revue de Presse – n°13

Revue de presse N° 13

Chers adhérents de DMB,

Veuillez trouver ci-dessous la revue de presse n° 13, parution du 31août 2014.

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DMB vous souhaite une bonne lecture !

Pour l’équipe des contributeurs

Christine Schneider Heyer

Key Considerations in the Transition to Risk-Based Monitoring
Therapeutic Innovation & Regulatory Science, July 2014, 48 (4)


Since 2011, the methodologies, products, and services available for risk-based monitoring (RBM) have proliferated and diversified, the biopharmaceutical industry can choose from a variety of general approaches. RBM is an important advance the potential to provide substantial improvements in data quality, patient safety and resource allocation. In these early days of the transition to RBM, pharmaceutical companies, CTMS vendors and CRO are typically adopting rudimentary quality management-based approaches that are likely to produce modest improvements. This article provides a framework to implementing a RBM approach or selecting a service provider.

Power Source
International Clinical Trials, summer 2014

Clean, reproducible site data remains a bedrock of clinical research, but with traditional methods feeling the strain, eSource is stepping forward. Ann Neuer at Medical deScriptions explores how it not only eliminates transcription errors, but also enhances risk-based monitoring.

Data Collection, (Tech Track)

International Clinical Trials, summer 2014

The clinical trial industry has devised methods and processes to minimize the variability in data collection: the query process. Unfortunately, this has timing and financial implications. The question then is this: what can we do better? This article relates, until today, all technologies which have been tested over the years. Mostly in imaging advances, several processes are now in place in order to find the best way to ensure consistent and credible results.

Three-Pronged Approach to Optimizing Trial Monitoring
Applied Clinical Trials, June 2014

This article reports the results of a clinical trial, which included 18 sites and 180 treated subjects; all the sites performed DDE (Direct Data Entry) and all the clinical research associates (CRAs) performed RBM (Risk Based Monitoring), with the bulk of monitoring activities occurring centrally from the home office. Results include recommendations and advantages of using DDE, RBM and also the interest of implementing the concept ‘quality by design’.

Shifting Monitoring Paradigms: Challenges and Opportunities
Applied Clinical Trials, June 2014

Through different surveys, this article reports more in details that often, sponsors/CRO and site professionals do not have the same perceptions of the impacts of RBM on clinical sites. The lack of communication and transparency with clinical sites about RBM has engendered misconceptions and disenfranchisement by clinical site staff. Today this is a source of challenges and opportunities to make of RBM, a success shared.


SCDM – eSource Implementation in Clinical Research

To achieve the full potential of eSource in clinical research, the process for data collection must be transformed from the traditional paper CRF collection model and associated paper site source documents to one that optimizes the availability of electronic data records while ensuring that data integrity and patient safety are not compromised. True transformation will preserve the requisite standards of conduct while reinventing the data collection process and governing regulations to fit the new electronic environment. This transformation is sure to surface many challenges—some real and some simply perceived.
The Society for Clinical Data Management (SCDM) has identified constructive principles and best practices for different modalities organized by process, people and technology to address these challenges. We present various data collection modalities of eSource and relevant considerations for successful implementation.