Research clinical evaluation

Hydrazine sulfate [10034-93-2] N2H4 H2SO4, originally advanced by the Syracuse Cancer Research Institute for treatment of cancerous cachexia and tumor inhibition (221), now has Investigational New Dmg (IND) status in the United States. Clinical evaluations are under way at various institutions such as Harbor-UCLA Medical Center (222) and the Mayo Clinic. After extensive trials, hydrazine sulfate has been approved as an anticancer dmg in Russia (223). Chemical stmctures for estabUshed dmgs in the United States may be found in Reference 224. 

As medical researchers continue to explore the therapeutic properties of interferons, chemical engineers will continue to provide the expertise needed to make available the quantities of these molecules necessary for clinical evaluation. 

National Research Council Clinical evaluation of naltrexone treatment of opiate-dependent individuals report of the National Research Council Committee on Clinical Evaluation of Narcotic Antagonists. Arch Gen Psychiatry 35 335—340, 1978... 

A problem long appreciated in economic evaluations, but whose seriousness has perhaps been underestimated (Sturm et al, 1999), is that a sample size sufficient to power a clinical evaluation may be too small for an economic evaluation. This is mainly because the economic criterion variable (cost or cost-effectiveness) shows a tendency to be highly skewed. (One common source of such a skew is that a small proportion of people in a sample make high use of costly in-patient services.) This often means that a trade-off has to be made between a sample large enough for a fully powered economic evaluation, and an affordable research study. Questions also need to be asked about what constitutes a meaningful cost or cost-effectiveness difference, and whether the precision (type I error) of a cost test could be lower than with an effectiveness test (O Brien et al, 1994). 

These must be worthwhile objectives and the recent identification by a number of research groups (see Skovronsky and Lee 2000 for description and details) of P-secretase as the membrane-bound aspartyl protease (RACE), S-site APP cleaving enzyme, paves the way for developing possible chemical inhibitors of its activity for experimental and clinical evaluation, although that remains for the future. 

Research (on medicines). Numerous definitions of research are used both in the literature and among scientists. In the broadest sense, research in the pharmaceutical industry includes all processes of medicine discovery, preclinical and clinical evaluation, and technical development. In a more restricted sense, research concentrates on the preclinical discovery phase, where the basic characteristics of a new medicine are determined. Once a decision is reached to study the medicine in humans to evaluate its therapeutic potential, the compound passes from the research to the development phase. 

Tennant FS, Tarver AL, Rawason RA (1983) Clinical evaluation of mecamylamine for withdrawal from nicotine dependence. In Harris LS (ed) Problems of drug dependence, NIDA Research Monograph 49. USDHHS publication no, 84-1316, pp 239-246 Tercyak KP, Herman C, Audrain J (2002) Association of attention-deficit/hyperactivity disorder symptoms with levels of cigarette smoking in a community sample of adolescents, J Am Acad Child Adolesc Psychiatry 41 799-805... 

There are a number of critical elements in an efficient university clinical pharmacology department. They include teaching, analytical and experimental laboratory work, clinical service, drug information and critical appraisal, advisory support for the professions, drug safety research and evaluation, and pharmacovigilance. 

The fact that no satisfactory oxygen carrier has reached commercialization after over half a century of intensive research, first on hemoglobin-based oxygen carriers and subsequently also on PFC-based products, attests that the challenges were more formidable than anticipated. This chapter will consider only the PFC approach. Since this approach has recently been reviewed extensively by the authors [8,20-22], it will be limited to a brief overview of the challenges, solutions, present state of clinical evaluation, and most recent developments. 

To set the stage, it is useful to put this topic in the larger context of the dramatically changing health care environment and its implications for drug research, development and clinical evaluation. 

With increasing interest in undertaking animal experimental and human clinical and intervention studies to evaluate the role of lycopene in cancer prevention, it is important that well-established molecular and clinical markers of cancer be used in these studies. In general, the main clinical end points used in animal and human experiments are the tumor burden and volume and survival rates. Now that our understanding of cancer pathology has advanced, several molecular events are beginning to be recognized and used in research to evaluate the outcomes from intervention studies. A brief overview of some of the more important molecular markers of cancer that can and should be used in future studies is presented in this section. 

Greenhalgh D. The role of monocytes/macrophages in wound healing. In Robinson JP, Babcock GF (Eds), Phagocyte Function A Guide for Research and Clinical Evaluation. Wiley-Liss Inc., 1998, pp. 349-357. 

Outcomes research is defined as studies that attempt to identify, measure, and evaluate the end results of health care services. Outcomes research may evaluate not only the clinical effects of health care services but also the economic and humanistic impact of these services. Proponents of outcomes research believe that we should measure not only the clinical and cost impacts of health care but also outcomes that take factors... 

Nonclinical Studies In vitro (laboratory) or in vivo (animal) pharmacology, toxicology and pharmacokinetic studies that support the testing of a product in humans. Usually at least two species are evaluated prior to Phase I clinical trials. Nonclinical studies continue throughout all phases of research to evaluate long-term safety issues. 

The goal of the IRB (known also as the Independent Ethics Committee, or IEC) is the protection of the rights, safety, and welfare of human subjects involved in clinical research investigations. The review board is, therefore, primarily responsible for the evaluation of the proposed research. All evaluations should have the following objectives (a) to determine that the research is properly designed (b) to determine that the benefit of the intended therapy will outweigh the potential risk and (c) to determine that the patient will be provided with adequate information to enable him or her to make an informed decision regarding participation in the clinical trial. 

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