Database clinical studies

Kranzler HR, Bauer LO, Hersh D, et al Carbamazepine treatment of cocaine dependence a placebo-controlled trial. Drug Alcohol Depend 38 203-211, 1995 Levin FR, Lehman AF Meta-analysis of desipramine an adjunct in the treatment of cocaine addiction. J Clin Pharmacol 11 374-378, 1991 Lima MS, Reisser AA, Soares BG, et al Antidepressants for cocaine dependence. Cochrane Database Syst Rev 4 CD002950, 2001 Ling W, Shoptaw S, Majewska D Baclofen as a cocaine anti-craving medication a preliminary clinical study 0etter). Neuropsychopharmacology 18 403 04, 1998... 

The site contains information on thousands of clinical studies sponsored by the NIH, other federal agencies, and the pharmaceutical industry in about 100,000 locations worldwide. Studies listed in the database are conducted primarily in the United States and Canada, but include locations in about 90 countries. ClinicalTrials.gov gives information about a trial s purpose, who may participate, locations, and phone numbers for more details. In addition, a glossary is available that will help people become familiar with the most common clinical trial terms. 

Numerous epidemiological and clinical study reports confirm that SSRIs cause a high rate of mania in children and youth. Again, as noted earlier in this chapter, Martin et al. (2004) used a national database of more than 7 million privately insured individuals, aged 5-29 years, and found that the highest risk of manic conversion while taking antidepressants was in the 10- to 14-year-old group. 

A review of the prechnical studies, clinical studies, and postmarketing surveillance data has given no support to the proposed association between bambuterol and cardiac failure. The UK Committee on Safety of Medicines has received no spontaneous reports of cardiac failure due to bambuterol. Data from the WHO database, INTDIS, show no reports of cardiac failure with bambuterol, in contrast to ten reports for salmeterol. 

The length of the preclincial period was estimated from data in the CSDD database on NCEs approved for marketing by the U.S. Food and Drag Administration (FDA) in the years of the study. The preclinical period is defined in that database as the length of time from synthesis of a drug to the beginning of human clinical studies. 

As a consequence of the new legislation for clinical trials, documentation on the quality and preclinical (i.e., toxicological) data of investigational medicinal products, including radiopharmaceuticals, needs to be submitted to obtain approval from the national health authorities in the member states prior to initiating a clinical study in humans. Furthermore, all clinical trials which started in the European Union after 1 May 2004 need to be recorded in the European EudraCT database (European Commission 2003 b). 

A robust database exists from observational studies, clinical studies/trials, animal studies, and in vitro studies demonstrating that fatty acids play a key role in chronic disease risk. Population studies show a positive correlation between coronary heart disease (CHD) risk and dietary SFA (Hu et al., 1997 Keys, 1970 Kromhout et al., 1995) and an inverse association with PUFA (Hu et al., 1997). The Nurses Health Study (Hu et al., 1997) reported an inverse relationship between the PUFA SFA ratio and CHD risk. By all estimates, replacing 5% of energy from SFA with PUFA or MUFA would reduce risk of CHD by -48 and 36%, respectively. The relationship between dietary fat intake and risk of CHD is illustrated in Figure 20.2. Tram fatty... 

FDA can audit the records of the study sponsor, as well as contract research organizations (CROs), to review standard operating procedures and all of the documents related to a particular clinical study, including electronic databases. Since 1981, nearly 200 such inspections have occurred. Departures from regulations requiring voluntary corrective... 

If the principal barrier to switch has been a lack of clinical experience with a drug, this can be remedied by the collection of a large adverse reaction database. Once this is done, it is usually straightforward to establish that the drug is safe in prescription use. This is a major advance on the road to OTC approval, but it certainly does not yet prove that the drug will be safe and effective in the hands of consumers without the benefit of a learned intermediary. In order to establish this additional point, it is almost always necessary to supplement the analysis of adverse reaction databases with clinical studies in realistic conditions, using the labeling composed for the OTC product. 

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