Clinical investigators sources

Those siderophores with low molecular weight, nonpeptidal structures are anticipated to be stable to proteolytic enzymatic degradation, and less likely to evoke an immune response. The antibiotic can be selected from commercial sources or from a large arsenal of potential antibiotics with low solubility that were overlooked, or never underwent extensive clinical investigations. 

FDA investigators compare information that clinical investigators provided to sponsors on case report forms with information in source documents such as medical records and lab results, says Carolyn Hommel, a consumer safety officer in DSI. 

Bovine pancreatic DNase I was purified in 1945 [3], and it was the first DNase to be crystallized [4]. Until the availability of recombinant hrenun DNase (rUDNase) in the late 1980s [5], bovine pancreas remained the principal source of DNase 1, for biochemical as well as for clinical investigations. 

Four compounds are currently under clinical investigation for their use as anticancer agents (Fimre 1). These are ecteinascidin 743 (1), from the tunicate Ecteinascidia turbinateaplidine (dehydrodidemnin B, 2) from the ascidian Aplidium albicans dolastatin 10 (3) from the sea hare Dolabella auratium and bryostatin 1 (4) from the bryozoan Bugula neritina The marine environment has also been the source of a number of anti-inflammatory compounds such as pseudopterosin E, (5). The pseudopterosins constitute the major active components in a popular line of skin care products. ... 

To successfully identify and select clinical investigators, the sponsor s representatives need to identify internal and external sources of poten-... 

A description and analysis of any other data or information relevant to an evaluation of the product s safety and effectiveness obtained or otherwise received by the applicant from any foreign or domestic source. This should include information derived from clinical investigations (i.e., including controlled and uncontrolled trials of uses of the product other than those proposed in the application), commercial marketing experience, reports in the scientific literature, and unpublished scientific papers. 

To successfully identify and select clinical investigators, the sponsor s representatives need to identify internal and external sources for potential investigators define investigator selection criteria, protocol requirements, expected cost of the study, and investigator and facility qualifications interview potential investigators and, finally, schedule and conduct prestudy site evaluation visits. 

FIGURE 25.2 (a) Increase in MW over time of published medici-nai compounds, (b) Mean MW through clinical development (Source Investigational Drugs Database). Similar results found by Blake and Wenlock et al . The increase in MW between discovery compounds (leads) and preclinical compounds (candidates) has been studied in detaii by Oprea et... 

Thus, PDT started and continues as a treatment for solid tumors. However, there are also munerous other applications in use clinically or under pre-clinical or clinical investigations [5], as listed in Table 1. These applications exploit the different biological mechanisms that can be selectively activated, depending on the PDT treatment parameters. The invention of the laser and optical fibers in the 1960 s was also important for the development of PDT although non-laser sources can be used, the ability to deliver high intensity laser light to almost any site in flie body is critical for many applications. 

Careful documenfation is always very important since the report on a trial is usually written a long time, sometimes years, after the first patient is entered. The study protocol therefore serves not only as a basis of decisions made during the trial but also as the source of those decisions. The protocol is also important since clinical investigators may change or new ones join the study. In fact, a protocol should be written clearly in order to help researchers to repeat the trial elsewhere. All documents (including patient data collecting forms) should be kept for a long time to provide the possibility to reanalyze the trial if needed. 

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