Control in clinical trials

Fibrinolytic therapy is not indicated in any patient with NSTE ACS, as increased mortality has been reported with fibrinolytics compared to controls in clinical trials in which fibrinolytics have been administered to patients with NSTE ACS (patients with normal or ST-segment depression ECGs).10... 

Gotzsche PC (1989). Methodology and overt and hidden bias in reports of 196 doubleblind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control in Clinical Trials 10 31-56 Gruppo ItaUano per lo Studio della Streptochinasi nell Infarto Miocardico (GISSI) (1986). Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet 1 397-402 Gurwitz JH, Col NF, Avorn J (1992). The exclusion of elderly and women from clinical trials in acute myocardial infarction. Journal of the American Medical Association 268 1417-1422... 

Fibric Acid Derivatives. Fibtic acid derivatives have been used since the 1960s for control of blood Upid levels. The four most well-known compounds in this class ate fenofibrate, gemfibrozil, clofibrate, and bezafibrate, shown in Table 5. Fenofibrate has been the most popular fibtic acid derivative in Europe, and has mote tecentiy been investigated extensively in clinical trials in the United States (153). Bezafibrate is stmcturaHy related to clofibrate, and has tecentiy been reviewed by Western European and AustraUan clinical trials (154). 

E10 Choice of Control Group and Related Issues In Clinical Trials... 

Clinical trials must be conducted to establish safety in each target animal species which, in the majority of cases, will include food-producing species. Although the same types of animal may be involved in both pre-clinical and clinical trials, dear distinctions can be drawn between each type of study. Pre-clinical studies are only conducted in animals that are kept for the purposes of laboratory research, and that are usually maintained in a very controlled environment. Clinical trials, on the other hand, are conducted in animals that are representative of the normal conditions (field conditions) and purposes for which they are maintained. 

Data collection in clinical trials consists of the processes of collecting reliable clinical, control, and administrative data from the trial s participating sites... 

Computer-controlled systems [54] are commonly used in clinical trials to control dispensing and manage site inventories of trial supplies. Such systems are implemented with telephone voice-based or Internet web-based systems. 

Koop A, Mosges R. The use of handheld computers in clinical trials. Controlled Clin Trials 2002 23 469-80. 

Several studies have evaluated dietary supplements such as isoflavones, which are found in soy products and red clover. A well-controlled trial in more than 400 postmenopausal women evaluating a specific isoflavone, ipriflavone, found no benefits on bone mineral density or fracture rates after 3 years.47 Nevertheless, because these therapies are available without prescription and are not regulated by the FDA, patients may choose to self-medicate with isoflavones. Lymphocytopenia appeared in several patients treated with ipriflavone in clinical trials. Additionally, ipriflavone should be used with caution in immunocompromised patients or those with renal disease. It may inhibit CYP1A2 and CYP2C9 and may interact with drugs metabolized by those pathways, such as warfarin. 

Pain and joint function have been evaluated frequently in clinical trials administering hyaluronan to patients with OA. Results are conflicting, with some suggesting dramatic improvements and others indicating no effect. In one controlled trial, hyaluronan injections relieved pain to a similar extent as oral NSAIDs.29 Hyaluronan provides greater pain relief for a longer time than intraarticular corticosteroids, but corticosteroids work more rapidly.29... 

The preparation of a new drug substance or dosage form for evaluation in clinical trials must meet the same regulatory requirements and controls as a marketed product. The cGMP requirements for clinical trial products are outlined by FDA and are discussed in Chapter 20. 

Hudson, Christopher G., Socioeconomic Status and Mental Illness Tests of the Social Causation and Selection Hypotheses , American Journal of Orthopsychiatry 75, no. 1 (2005) 3-18 The Humble Humbug , The Lancet 2 (1954) 321 Hunter, Aimee M., Andrew F. Leuchter, Melinda L. Morgan and Ian A. Cook, Changes in Brain Function (Quantitative EEG Cordance) During Placebo Lead-in and Treatment Outcomes in Clinical Trials for Major Depression , American Journal of Psychiatry 163, no. 8 (2006) 1426-32 Hyland, Michael E., Do Person Variables Exist in Different Ways , American Psychologist 40 (1985) 1003-10 Hypericum Depression Trial Study Group, Effect of Hypericum Perforatum (St John s Wort) in Major Depressive Disorder A Randomized Controlled Trial , Journal of the American Medical Association 287 (2002) 1807-14... 

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