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International Clinical Trials

Looking for Disclosure

New regulations around the world have led to an explosion of clinical trials information in 2008. Transparency of trial data for the good of public health has been a long time coming, and, in this respect, 2008 has been a good year. However, we’re not quite ‘there’ yet in terms of collating, validating and interpreting the huge amount of data now available.

PATIENT WELFARE HAS NOT ALWAYS BEEN A HIGH PRIORITY

While today’s clinical trials are conducted in accordance with strict protocols of safety, patient care and data interpretation, history shows that patient welfare was not always a high priority. James Lind’s introduction of control groups in the 1740s led to his widely held status as the father of the clinical trial. However, subsequent to clearly proving the effectiveness of lemon juice in preventing scurvy, he hesitated to recommend including oranges and lemons in the diet of seafarers because of the high cost of the fruit (1,2).

The cornerstone of modern human experimentation ethics, the Nuremberg Code, came about shortly after World War II in response to Nazi atrocities during the war (3). Following its inception, the first randomised controlled trial was conducted in 1948, and the ethical impact of clinical trials has steadily increased in importance. A plethora of regulations now exists, focusing on patient safety and requiring informed consent from all participants. Along with the Nuremberg Code, the Declaration of Helsinki (1964 and updates) is core to the documentation for standard clinical trial procedure.


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Robyn Roper is a Medical Writer and Clinical Trial Analyst with Wolters Kluwer Health. She has more than 12 years of experience in clinical trial evaluation and medical writing across a broad range of therapeutic areas. Robyn currently writes and evaluates for the Adis Clinical Trials Insight® database.
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