Labelling clinical trial supplies

The new technology can be applied to both large-scale and small-scale production. In the latter case this is particularly relevant in the office and the production of special labels such as those used for clinical trial supplies. 

The other program involves systemic administration of the gene-laden adenovirus via a hepatic artery catheter to treat hepatocellular carcinoma (HCC). The hepatic artery supplies the normal liver with 25% of its blood supply. However, it is the sole blood supply for the carcinoma. Preclinical results demonstrated efficacy in a rat HCC model. In a small, open-label clinical trial of patients positive for HCC, but also having post-hepatitis cirrhosis, patient response was marginal [22]. 

Some countries require that clinical supplies be labeled with their expiration date. When that date is extended based on additional data, appropriate persons are notified and stickers with the new expiration date are distributed to those who hold the drug so that it may be overlabeled with the new expiration date. In this scenario, drug that is near its expiration date should be obvious and would not be used in a clinical trial. 

Complaints of adverse reactions to clinical supplies are typically seen as reportable events that impact the safety or efficacy of the test article. Companies should give consideration to the possibility that an increase in the frequency or severity of adverse reactions may be linked to a manufacturing defect. For example, a product that has been formulated such that it is super-potent in its final form can be expected to produce adverse reactions of greater severity or frequency than if it was properly formulated. Labeling mix-ups can have devastating impact on patients, or, at minimum, may seriously affect the validity of a clinical trial. Therefore, the following elements should be included in the complaint assessment system ... 

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