Clinical trials

Clinical trials serve to assess the safety and efficacy of any potential new therapeutic 'intervention' in its intended target species. In our context, an intervention represents the use of a new biopharmaceutical. Examples of other interventions could be, for example, a new surgical procedure or a novel medical device. Veterinary clinical trials are based upon the same principles, but this discussion is restricted to investigations in humans. Clinical trials are also prospective rather than retrospective in nature, i.e. participants receiving the intervention are followed forward with time.

Clinical trials may be divided into three consecutive phases (Table 4.4). During phase I trials, the drug is normally administered to a small group of healthy volunteers. The aims of these studies are largely to establish:

• the pharmacological properties of the drug in humans (including pharmacokinetic and pharma-codynamic considerations);

Box 4.2

Supplements For Diabetics

Supplements For Diabetics

All you need is a proper diet of fresh fruits and vegetables and get plenty of exercise and you'll be fine. Ever heard those words from your doctor? If that's all heshe recommends then you're missing out an important ingredient for health that he's not telling you. Fact is that you can adhere to the strictest diet, watch everything you eat and get the exercise of amarathon runner and still come down with diabetic complications. Diet, exercise and standard drug treatments simply aren't enough to help keep your diabetes under control.

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