Clinical research is an increasingly complex enterprise, which requires knowledge and skills that are outside the traditional training of physicians and other healthcare professionals. The investigator must, for instance, understand what are the responsibilities of screening research participants, obtaining free and informed consent and supervising a trial. Although it is primarily the sponsor or CRO’s […]
Category Archives: en
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Apr
Apr
When do you think this process begins? Take a moment to think about it before reading on… Does the informed consent process begin with the informed consent discussion? It may surprise you, but the “FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process”. This means […]
11
Apr
Apr
If you are a Sponsor/CRO conducting clinical research in both Canada and the U.S., there are important differences between the Canadian Clinical Trial Application (CTA) and the U.S. Investigational New Drug (IND) submission process. IND Submission Process in the U.S. In the U.S., once the IND has been submitted for review, the FDA has 30 […]
07
Apr
Apr
Are you involved in multi-national clinical research in North America? Are you wondering whether – and where – you have to register a clinical trial? And why? Why should we register this clinical trial? Let’s address the ‘why’ question first. Registration is internationally recognized as a scientific, ethical and moral responsibility that “will improve research […]
26
Mar
Mar
Comments on two articles recently published in NEJM In our last blog we referred to a recent edition of the New England Journal of Medicine (NEJM) in which prominent bioethicists argued that some comparative trials involving approved therapeutic or diagnostic interventions (also known as comparative effectiveness research (CER)) could be conducted without research participants’ consent […]
18
Mar
Mar
Comments on articles recently published in NEJM In a recent edition of the New England Journal of Medicine, prominent bioethicists argued that “some studies may justifiably proceed with a streamlined consent process and others may not require patient consent at all”. The authors also propose to streamline the oversight of some studies that fall “below […]