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Monthly Archives: February 2012
Cardiac Safety: Cost to Trials
Cardiac safety is cited as the most frequent reason for drug withdrawals from the market, labeling changes, delay or refusal of regulatory approval. This places great importance on the accurate collection, analysis, and interpretation of ECG data during clinical trials.
Posted in CRO/Sponsor, Labs, Sites, Trial Design Tagged Amy Furlong, cardiac safety, ECG, ERT Leave a comment
New Anti-Falsification Regulations for EU QPs
Although the falsification of data has been a concern in both the United States and Europe for several years, recently the issue has been brought to light more prevalently. The FDA proposed regulation for reporting the falsification of data in clinical trials in 2010, and the EU released new legislation regarding anti-falsification at the end [...]
Posted in Regulatory Tagged anti-falsification, EU, FDA, GxP Perspectives, Kayda Norman, QPs, qualified person, regulation, Wolfgang Schmitt Leave a comment
Take our Clinical Trial Feasibility Quiz
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Posted in CRO/Sponsor, Regulatory, Sites Tagged clinical trial feasibility, industry standard research, ISR, quiz Leave a comment
Take a Moment for the Patient
Late last month, CBI and Applied Clinical Trials hosted Patient Centricity in Clinical Trials, which included discussions on many aspects of clinical trials and how to put patients first so they feel more like valued participants in these trials. As the conference wrapped up, the final discussion included chronic disease patients with varying levels of [...]
When Oncology and Cardiac Safety Meet
Earlier this week, our blog Keeping up with Cardiac Safety featured slides I presented at the Cardiovascular Risk Assessment Summit at the end of January. We co-hosted the two-day event with CBI, our conference group, and it was full of very high-level scientifically-rich presentations, as well as conversations about the cardiologists and doctors in the [...]
Posted in Labs Tagged Cancer, cardiac safety, CardioCore, CBI, ETASU, FDA, Labs, Lisa Henderson, Lisa Hendrson, oncology, REMS Leave a comment
50 Years after Thalidomide: Why Regulation Matters
Fifty years ago, the vigilance of FDA medical officer Dr. Frances Kelsey prevented a public health tragedy of enormous proportion by ensuring that the sedative thalidomide was never approved in the United States. As many remember, in the early 1960’s, reports were coming in from around the world of countless women who were giving [...]
Posted in Regulatory Tagged FDA, Frances Kelsey, Margaret Hamburg, Regulatory, Thalidomide, Wayne Kubick Leave a comment
Should AERS Reports Do More For Patients?
Since its inception in 2007, the Food and Drug Administration Amendments Act (FDAAA) has required the FDA to “conduct regular, bi-weekly screenings of the Adverse Event Reporting System (AERS) database and post a quarterly report….[on] potential signals of a serious risk identified.” Although the act calls for the report of any AEs, it advises prescribers [...]
Will Europe’s New CT Rules Tackle Personalized Medicine Challenges?