In case you missed it, three of our experts were featured in the March 2012 issue of PharmaVOICE.
Ron Marks, Ph.D. Chief Scientific Officer, Clinipace Worldwide, is featured in the article, Molecule to Market – Along the Continuum.
Marks speaks about the technologies that exist to integrate trial data in a single system to maximize transparency of study information,
“Such integration allows the sponsor to keep enrollment on target, investigators to enter clinical data more accurately and timely, monitors to more expeditiously check and validate clinical data, and data managers and biostaticians to efficiently produce clean and complete data.”
Andrea Schiefer. VP, European Clinical Operations, Executive Director, Pharmacovigilance and Carla Radke, Senior Director, Clinical Monitoring, Clinipace Worldwide, are also featured in the article, Rising Costs Are Top of Mind in Phase III. In talking about the best practices for patient recruitment, Schiefer states,
“In-depth understanding of the opinions of the regulatory authorities and other stakeholders, such as the health insurance funds in the different regions where the study is conducted, is required. Additionally, a poorly designed or ambiguous protocol or case report form (CRF) may introduce systemic errors that can raise costs of a trial tremendously. A well-planned and designed protocol and CRF are key.”
“Sponsors have to implement monitoring plans to identify and exclude sites that are not performing well. They have to train the investigators and plan to implement alternative training and communication methods – teleconferences, webcasts or online training modules – for providing and documenting ongoing, timely training and feedback. Pharmaceutical companies should conduct aggregate statistical analyses of study data to identify sites that are outliers relative to others and to evaluate individual subject data for plausibility and completeness.”
Radke gives insight into designing a trial whereas to cut costs,
“A decision is then made sooner whether to continue the trials. Sites can commit to enrolling a certain number of subjects contractually. Even if there are competing studies, if they have agreed contractually, hopefully, sites will reach their quota.”