Schools Training

Clinical Research Testing on Different Subjects

12 OCT 2012
Career Path : Healthcare

There is nothing particularly revolutionary when it comes to product testing in everyday commerce. Manufacturing companies want to know if their products can be sold successfully, who their intended market is, and how the products will hold up in various conditions. The only risk which comes from lack of proper testing might be poor sales. But this isn’t always the case for all industries. When it comes to pharmaceuticals, the proper administration of clinical testing is more than just good business; it can mean the difference in the treatment of diseases and the health and well-being of many sick people. For this reason, pharmaceutical companies must undergo rigorous and multi-phase clinical testing before marketing a new drug.

Different countries have different laws regarding how a drug is clinically tested. These differences range from length of test periods, amount of test subjects, doses, follow-ups, and the variety of unexpected side-effects that need to be examined separately after the drug has been given. No matter where, however, one of the issues when it comes to pharmaceutical testing is what kind of subjects should be used in the test, and to what extent. Three common types of test subjects are animals, healthy subjects, and subjects for whom the specific drug is intended once approved for use.

Based on these differences, clinical research is broken up into phases, where results are monitored and analyzed before the testing advances.

Animal Testing

This is often the first phase of testing. The advantage of this is that it eliminates the risk of causing physical harm to human beings if a drug has harmful effects, though not completely, because not all animals have the same biological makeup. As for arguments of animal cruelty, animal testing is being limited, and many regulations have been put in place to avoid or limit these claims.

Healthy Subjects

Using relatively low doses of a drug, the use of healthy subjects can help determine if the drug has unexpected effects on humans. It also helps demonstrate the human resistance to drugs. The aim of this stage is not to determine if and how the drug works, but to monitor how the body reacts and eventually expels it.

Subjects Intended For the Drug

Once initial safety has been cleared, the drug is given to people who suffer from the disease the drug is meant to treat, probing mainly the drug’s efficacy. Non-healthy subjects often must return for repeat testing over lengthy periods of time, in order to establish the effects regarding a disease’s complete resistance and the potential for a complete cure. It is often during this phase that a drug can fail the clinical testing or require basic fundamental modifications.

Because of its crucial role in pharmaceuticals and the entire healthcare industry, many schools have programs specializing in this field. There are plenty of clinical research courses that include practical work placement, where one could get experience before entering this important career.

Visit the Academy of Applied Pharmaceutical Sciences for information about clinical research training.