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The article offers suggestions for meeting regulatory concerns regarding Electronic Data Capture (EDC) data integrity and site control over the source of data in clinical trials. Topics include the consensus across the pharmaceutical industry regarding the maintenance of clinical data by writing results on papers; the guidelines of the U.S. Food and Drug Administration regarding use of electronic data in clinical trials; and guidelines of European Medicines Agency regarding electronic data.

The article discusses the activities of European Union related to integrating biomarkers and personalized medicine techniques into studies. Topics include an annual gathering in October 2015 on how patients will be impacted by adaptive pathways and breakthrough designations, the European Medicines Agency's (EMA) pilot project on adaptive drug pathways, and a paper of their own on personalized medicine.

The article discusses the developments in risk-based monitoring, with particular consideration on the evolution of the role of clinical research associate (CRA) in clinical trials. Topics include CRAs and the application of informatics technology in lign with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and significant role of CRAS including increased use of specialist skills, focus on high-value compliance inspections, and quality by design.

The article reports on the future of pharmacovigilance in the field of applied clinical research in Europe. Topics discussed include risk management, signal detection, and periodic reporting. Also being discussed are the topics like the good pharmacovigilance practices (GPVs) of the European Medicines Agency (EMA).

The article offers information on European Medicines Agency updated its plan for existing guideline on first-in-human clinical trials. Topics discussed include use of integration of pharmacokinetic and pharmacodynamic data, aim of the guideline to increase first-in-human clinical trials, and need to introduce principle for starting dose in humans and dose escalation.

The article focuses on the issues regarding writing and constructing layperson summaries of clinical trial results in European Union (EU). Topics discussed include European Parliament released the Regulation 536/2014 on clinical trials on medicinal products for human use, European Medicines Agency (EMA) implemented a public European database in which to collect and retrieve all relevant information on clinical trials submitted to the agency and target audience for a layperson summary.

This 2018 survey findings showed that approximately two thirds of sponsor respondents and three quarters of CROs have adopted some type of RBM. Small pharma/biotech and small CROs were the main organizations that have not adopted RBM in the five years since the 2013 FDA and European Medicines Agency (EMA) releases of recommendations for adopting a risk-based approach to monitoring, m A wide variety of implementation approaches have been adopted, with varying ability to detect "errors that matter." A significant, unmet medical need exists to test and publish data to determine the effectiveness of the different RBM implementation approaches. This would help the industry make informed decisions about how to best protect study participants' safety and obtain scientifically valid data to support the delivery of new medicines for patients. [ABSTRACT FROM AUTHOR]

The article looks at the proposed revisions by the European Medicines Agency (EMA) to guidance on first-in-human clinical trials. Topics covered include the EMA being prompted to revisit the guidance following the death or hospitalization of volunteer subjects during a trial performed by French research organization Biotrial for drugmaker Bial, the suggestion by the EMA to explore a dozen of areas when dealing with protocols, and the need to expand the non-clinical aspects of the guideline.

The article reports on the launch of a survey by the European Medicines Agency (EMA) to understand the awareness of patients and healthcare professionals about the adverse drug reactions in Europe in 2017.