Clinical trials review

Clinical Trial Data Collection Systems Clinical Trial Review Tools Inventory System Electronic Publishing Regulatory Submissions... 

Clinical Trial Review and Approval, Drugs Directorate, Policy Issues, Health and Welfare Canada, 1995. TPP (Therapeutic Products Program, Canada), http //www.hc-sc.gc.ca/hpb-dgps/ therapeut/htmleng/whatsnew.html. 

Brass, L.M. (2004) Hormone replacement therapy and stroke clinical trials review. Stroke, 35, 2644-2647. 

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). 

Cionidine. Clonidine dampens sympathetic activity originating at the locus coeruleus by stimulation of presynaptic a2-adrenergic receptors in the sympathetic chain (Covey and Classman 1991 Hughes 1994). It appears to have some efficacy for alcohol and opioid withdrawal and thus was evaluated for treatment of nicotine withdrawal as well (Covey and Classman 1991 Hughes 1994). Several clinical trials used oral or transdermal clonidine in doses of 0.1—0.4 mg/day for 2—6 weeks with or without behavior therapy. Three meta-analytic reviews reported that clonidine improved quit rates (Covey and Classman 1991 Courlay and Benowitz 1995 Law and Tang 1995). 

Compound 34 (BCZ-1812, RWJ-270201, peramivir) showed selective inhibition of influenza virus sialidases over bacterial and mammalian sialidases (Babu et al. 2000 Bantia et al. 2001 Sidwell and Smee 2002). Successful inhibition of influenza virus infectivity in vitro (Smee et al. 2001) and upon oral administration in vivo [mice (Bantia et al. 2001) and ferrets, reviewed in Sidwell and Smee 2002] led to human clinical trials of orally administered peramivir (Barroso et al. 2005). While orally administrated peramivir successfully completed animal studies and Phase I and Phase II clinical trials, in which the compound was showing neither major side effects nor toxicity (Sidwell and Smee 2002), preliminary results of the Phase III trials (June 2002) demonstrated no statistically significant difference in the primary efficacy endpoint, possibly due to low bioavailability (Barroso et al. 2005). 

In the clinical setting, zanamivir 12 and oseltamivir 19 are effective in both the prevention and treatment of influenza A and B infection. Benefit in treatment is restricted to patients treated within 48 h of symptom onset (Fleming 2003). Importantly, the effects of drug treatment are a rednction in the severity of illness, and in the incidence of secondary complications. The term of illness is generally rednced between 1 and 2.5 days. The evalnation of zanamivir (Calfee and Hayden 1998 Oxford 2000 Fleming 2003), oseltamivir (Doncette and Aoki 2001 Oxford 2005) and peramivir (Sidwell and Smee 2002) for the treatment, and prophylaxis, of inflnenza virus infection has been reviewed. The reader is directed to these reviews for further details of drug pharmacodynamics and clinical trial data. 

Errors and Inconsistencies in Formatting Dates. It is also necessary to use standardized formats to record dates. For example, Oracle stores a date as the number of seconds since January 1, 4712 BC, and then uses various functions to display the dates in more human-friendly formats. There are many different and personal ways for recording dates one of the authors (AS) has noted at least 25 different ways in a single clinical trial submitted for FDA review Should February 1,2007 be recorded as 1 February 2007,1 Feb 2007, 1 Feb 07, or 02/01/07 This problem still exists when data for numerical dates are extracted into software programs such as Excel that do not force the user to select a unique format for dates. 

Evelyn B, Toigo T, Banks D, Pohl D, Gray K, Robins B, Ernat J. Women s Participation in Clinical Trials and Gender-Related Labeling A Review of New... 

This section will review the phase III clinical trials of IV thrombolytic agents for acute ischemic stroke, organized by the type of agent and the time window from stroke onset to study drug delivery (Table 3.1). The 1995 National Institute of Neurological Disorders and Stroke (NINDS) rt-PA trial is presented first because it showed that IV rt-PA, given within 3 hours of stroke onset, reduced stroke-related disability. This trial was the basis for the United States Food and Drug Administration (FDA) approval for rt-PA for use in acute ischemic stroke. 

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