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Clinical researchers can use mobile technologies to improve the trial process if they focus on patient-centric measures and engagement with regulators, according to the Clinical Trials Transformation Initiative (CTTI). Read More
The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource — the staff of its Office of Good Clinical Practices. Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Read More
The use of risk-based monitoring in clinical trials is expected to climb — with many sponsors planning to implement policies for the first time over the next two years — driven by the need to reduce oversight costs and mitigate risks. Read More
How much training do clinical investigators and clinical study staff need to stay up to date on good clinical practices, particularly to ensure compliance for multiregional clinical trials? In a recent study, the Clinical Trials Transformation Initiative evaluated the content, frequency, format and enrollment evidence of GCP training and provided recommendations to improve the efficiency of GCP training. Jonathan Seltzer, the director of clinical research at the Lankenau Heart Institute and a co-author of the study, “Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency,” talks with CTA about the findings.Read More
The FDA has dinged a clinical investigator in a warning letter for failing to conduct an investigation, according to the investigational plan. Read More
Drugmakers submitting anonymous clinical data in applications to the European Medicines Agency must keep up on technology advances that could put that data at risk for re-identification. Read More
The International Committee of Medical Journal Editors is seeking feedback on proposed requirements involving transparency for clinical trials authors as a condition for publication in member journals. Read More
CBER’s Allergenic Products Advisory Committee gave a less than stellar assessment on the outlook of clinical trials for immunotherapies to treat food allergies. Read More