Understanding Clinical Trials

The Double-Edged Sword of Off-Label Prescribing

When a pharmaceutical representative leaves clinical training and enters the field, she very quickly learns two things: First, doctors don’t always respond the way they did in role-play scripts. And second, doctors don’t always prescribe medications for their government-approved indications. The prevalence of off-label prescribing can make navigation within the physician community fraught with regulatory [...]

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Phase I Trials and the TGN1412 Controversy

Phase I trials can be easily overlooked because these studies involve a small number of human subjects. Indeed, most phase I trials may not accurately reflect the safety profile of a new treatment in a general population. Phase I trial results beyond safety profiles are also difficult to interpret. However, a therapy entering phase I [...]

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Watching the subject

Last month, we looked at two types of experimental trial designs: randomized controlled and crossover trial designs. In this column, we will look at selected types of observational studies and how each contributes to the appraisal of study data.

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Arm movement

Clinical studies yield evidence that guides physician practice. The robustness of clinical evidence depends on the type and design of the clinical study. Clinical studies may be classified as either experimental or observational (also called descriptive) studies.

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Good clinical practice: The foundation of clinical trial success

Clinical trial failures and successes are frequently announced in industry news-feeds. Recently, another aspect of clinical research has come under public scrutiny: clinical trials conduct. Controversies surrounding publication of all clinical trials data and conflicts of interest are plaguing clinical research physicians (often called clinical investigators) and pharmaceutical companies alike.

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