IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For June 2016
By Ed Miseta, Chief Editor, Clinical Leader
Below are my top three articles downloaded on Clinical Leader for the month of June 2016. In case you missed them, please take this opportunity to see what everyone else was learning about the clinical tragedy in France, using source data verification as a quality control measure in trials, and where the industry stands on eSource implementation.
France Tragedy Update: Bial & Biotrial At Fault; EMA Reviews Guidelines
In January, a clinical trial tragedy in France claimed the life of one healthy patient and caused serious brain damage in five others. In May, the French Health Ministry found fault with the two companies involved in the trial, noting Bial and Biotrial were at fault on several counts, including how much of the drug they gave volunteers, how long it took them to inform the government about the problems, and for failing to properly inform the other volunteers. In light of this, the European Medicines Agency (EMA) is hoping to improve the safety of FiH clinical trials.
Source Data Verification: A Quality Control Measure in Clinical Trials
In an industry that seems to be focused on cutting the cost of clinical trials, it’s no surprise that reducing the amount of source data verification (SDV) performed in studies—the process of cross-referencing data recorded in a case-report form to the original source information—is an integral part of risk-based monitoring (RBM) strategies. Eliminating source data checks that do not add value to the study is certainly a breakthrough for trials where we have historically performed 100 percent data verification. After all, why verify data that we already know to be correct, and is a low risk to the study as well?
eSource Implementation: Where Are We Now And Where Are We Going?
Over the last several years, life science firms have cautiously moved into the eSource arena. While companies look forward to attaining the benefits of eSource, they also have concerns over potential glitches, the impact on study teams, and regulatory issues.
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