News

Patient involvement, transparency, and support for innovative medicines are among the key objectives of the European Medicines Agency (EMA) over the next five years, according to Executive Director Prof. Guido Rasi.

Potential assets that could benefit from this new offering include small molecule drugs, biologics, medical devices, combination therapies and novel technologies.

Scientists plan to use the funds to repurpose Artesunate, an antimalarial drug discovered by Nobel Prize Laureate (2015) in a clinical trial aimed at cutting the rate of metastases in colorectal cancer.

ICON is using Activate for all global studies, which span more than 50 countries.

Nextrials CEO James Rogers believes with renewed focus on eSource driven by the FDA and industry standards groups like CDISC, sponsor companies and sites will take advantage of EHR systems to streamline clinical research.

The acquisition provides ICON with access to PMG Research’s network of 48 physician practices and large multi-specialty healthcare institutions throughout North Carolina, South Carolina, Tennessee and Illinois.

Bio-Optronics will participate as a Global Impact Partner (GIP).

Results from an analysis of oncology trials suggest that many patients who are excluded from participation in clinical trials due to an elevated ECG machine-generated QTc measurement may actually have been eligible for study participation.

A follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.

The BMJ published a detailed report this week about how pharmaceutical sales representatives are screening people in India in return for prescriptions for their products. It also addresses the growing popularity of free “health camps” for poor people in India.

IMS data show the importance of the role clinical investigators play in prescribing.

Subject Recruitment: The Ideas Initiative Trial Design: Early Phase CNS Drug Liabilities; Improving Enrollment Forecasts Also in this issue: Update on Europe's Clinical Trial Rules Debate Public Perception of Clinical Research Clinical Trial Barriers

Regulatory: Assessing Study Drop in CEE Swiss Syncs Up Regulations Sites: Regional Risks in Eastern Europe Also in this issue: Orphan Drug Hurdles in Europe Patient Engagement: Illness-Level Impact Clinical Trial Technology in 2025

Click the title above to open the Applied Clinical Trials December 2015/January 2016 issue in an interactive PDF format.