When assessing new therapeutic goods through clinical trials, researchers must obtain information on the degree of a patient’s physical response to therapy. This data then undergoes detailed statistical analyses in order to determine the safety and efficacy (effectiveness) of the drug or treatment.
Central to Clinuvel’s clinical trial design, and the value of these studies, is measurement of the severity of phototoxic reactions (adverse reactions to light or UV radiation) in trial patients. In order to do this accurately, a symptom severity scale has been developed based on the method of ‘Likert scaling’.
The dictionary defines a patent as …a grant made by a state or government that confers upon the creator of an invention the sole right to make, use and sell that invention for a set period of time.
Clinical trials are complicated and often the results can be even more so. Close monitoring of the interactions between patients, diseases, conditions and drugs for extended periods of time and the various questions posed in order to prove or disprove safety and efficacy of particular treatments result in an accurate yet highly complex mountain of data.
In January 1983 the United States government passed an Act that has had a profound impact on pharmaceutical development and the individuals whom it was intended to benefit. The Orphan Drug Act (ODA) was lobbied for successfully by the National Organisation for Rare Disorders (NORD) and provides incentives for researching and developing treatments for rare or ‘orphan’ diseases.
Manufacturing drugs for human use is a complicated process frequently involving compounds and materials that, if used incorrectly, can be hazardous to people’s health. Highly regulated nations (such as the US, EU, Australia and Canada) have long realised the necessity that they develop strict guidelines governing these processes to protect patients and ensure product safety, quality and efficacy. Poor quality drugs, manufacturing processes or conditions can have extreme and dire consequences for patients. In countries that enforce Good Manufacturing Practice (GMP) the penalties for non-adherence reflect its importance and can include forcing worldwide product recalls, seizure of property, large fines, even imprisonment.
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