Labelling Clinical Trials Directive

The United Kingdom Medicines Act 1968 regulations require that all medicinal products are properly labelled to certain minimum standards, but requirements vary from country to country. Clinical trial materials, however, cannot be labelled normally because if the trial is blind, nothing should reveal to the patient or physician the nature of the contents. The basic information on the label should provide the patient s name, study phase, study number, directions for use, any special warning or storage requirements, expiry date and the investigator s name and address, along with an indication that the... 

Grants FDA greater authority over drug marketing, labeling, and direct-to-consumer advertising requires post-approval studies, establishes active surveillance systems, makes clinical trial operations and results more visible to the public. 

Phase III Clinical Trials Consist of controlled and uncontrolled trials that are performed after preliminary evidence of effectiveness of a drug has been established. They are conducted to document the safety and efficacy of the drug, as well as to determine adequate directions (labeling) for use by the physician. A specific patient population needs to be clearly identified from the results of these studies. Trials during Phase III are conducted using a large... 

Random polymers that contain amino acids commonly used as MHC anchors and T-cell receptor contact residues have been proposed as possible universal altered peptide ligands. Glatiramer acetate (GA) is a random sequence polypeptide consisting of four amino acids (alanine [A], lysine [K], glutamate [E], and tyrosine [Y] at a molar ratio of A K E Y of 4.5 3.6 1.5 1) with an average length of 40-100 amino acids. Directly labeled GA binds efficiently to different murine H2 I-A molecules, as well as to their human counterparts, the MHC class II DR molecules, but does not bind MHC class II DQ or MHC class I molecules in vitro. In clinical trials,... 

With these data in hand, permission was obtained from the United States Food and Drug Administration to initiate the first clinical trial of an "At-labeled therapeutic. This protocol involves the injection of At-labeled chimeric 81C6 directly into the surgical tumor resection cavity of patients with recurrent brain tumors (Zalutsky et al. 2001). The results to date have been very encouraging with a median survival of about 60 weeks observed, compared with about 25-30 weeks for recurrent brain tumor patients treated by conventional therapies. 

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