Data Standards Featured Articles
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How To Prepare Clinical Data For Greater Transparency
4/23/2014
With the rationale of making Europe a better environment for clinical research, the European Union is taking steps towards greater transparency of clinical trial data. In this article, CROS NT highlights the connection between traceability and transparency, and makes recommendations on how to satisfy the regulatory authorities and be prepared for future clinical data transparency obligations.
Background
A recent initiative (April 2014) by the European Medicine Agency (EMA) on data transparency was finally passed into draft law by the European Union, requiring that detailed summaries of clinical trials are published in a publicly accessible database once marketing authorization is granted. Sponsors could face strict fines for not complying. Also, in March 2014, the EMA published the first summary of a risk management plan (RMP) for a newly authorized medicine, stating “the Agency will pilot the publishing of RMP summaries for all newly centrally authorized medicines during 2014 and at a later stage will start producing RMP summaries for previously authorized medicines”. The RMP will be a publicly available document that describes all that is known and unknown about a drug’s safety and what actions will be taken to monitor the drug on the market and mitigate any risks.
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Do The Right Thing: GSK’s Case For Data Transparency
10/2/2013
GlaxoSmithKline’s head of science and innovation argues that the future progress of R&D industrywide depends on open but qualified sharing of all clinical-trials data.
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Overcoming Common Missteps In Clinical Trials
12/28/2012
What steps you can take to overcome the most common problems in clinical trials such as, study designs and lack of sufficient exploration into study conduct processes that could affect the analyses and interpretation?
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mHealth Could Cut Clinical Trial Time And Money In Half
10/31/2012
Clinical Trials is one healthcare area being driven forward by technology with the ubiquity of smartphones. Patients can use their smartphones to capture real time data.
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Going Virtual: Making The Most Of A New Age Of Clinical Development
12/7/2011
Clinical development is now entering an era of virtualized research that has the potential to accelerate and bring new levels of cost-efficiency to the drug development and trial process. By Neil de Crescenzo