IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For February 2016
By Ed Miseta, Chief Editor, Clinical Leader
Below are my top three articles downloaded on Clinical Leader for the month of February 2016. In case you missed them, please take this opportunity to see what everyone else was learning about protocol design and EMA recommendations surrounding the clinical tragedy in France, and biopharma trends that will impact clinical trials in 2016.
Did Poor Protocol Design Lead To The Clinical Accident In France?
Did the clinical trial in France that has left one person dead and several others hospitalized have flaws in the protocol design? While we continue to await new information on what may have caused the tragedy, some researchers are already speculating on whether or not the design of the trial may have been a factor, and are demanding more information be released.
Report: EMA Recommendations Were Not Followed In France
ANSM, the national drug safety agency in France, has issued a timeline of the events that culminated in the death of one trial participant and the hospitalization of five others at a clinical trial performed at clinical research firm BIOTRIAL. As was speculated by researchers at the UK’s Royal Statistical Society (RSS) last week, the timeline confirms that all six of the volunteers who were hospitalized after the study received an escalation of the dose at the same time.
Biopharma Trends That Will Impact The Industry In 2016
The beginning of the year is always a good time to take a look ahead at the trends most likely to impact the industry in the coming months. One area that is changing quickly, and which promises to impact clinical trials in the coming years, is biopharma. I recently spoke with Jim Esinhart, CEO of Chiltern, about some of these trends, including study protocols, big data, mergers, and new technologies.
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