Randomized clinical trial

Ling W, Weiss DG, Charuvastra VC, et al Use of disulfiram for alcoholics in methadone maintenance programs. Arch Gen Psychiarry 40 851—854, 1983 Ling W, Charuvastra C, Collins JF, er al Buprenorphine maintenance treatment of opiate dependence a multi-center, randomized clinical trial. Addiction 93 475-486, 1998... 

Carroll KM, Sinha R, Nich C, er al Conringency management to enhance naltrexone treatment of opioid dependence a randomized clinical trial of reinforcement magnitude. Exp Clin Psychopharmacol 10 5d—63, 2002 Carroll KM, Fenron LR, Ball SA, er al Efficacy of disulfiram and cognitive behavior rherapy in cocaine-dependenr ourparienrs. Arch Gen Psychiatry 61 264—272, 2004... 

Abdellatif M, Reda D. A Paradox-based data collection and management system for a multi-center randomized clinical trials. Comput Methods Prog Biomed 2004 73 145-64. 

Chen J, Meloro L, Eng H, Wisniewski S. Using SAS to create and e-mail individualized reports in a multi-center randomized clinical trial. Clin Trials 2005 2 S64. 

Swanson A. Computerized bedside randomization in a randomized clinical trial. Controlled Clin Trials 2003 24 3S 166S. 

Figure 27.2 A display that summarizes the duration of treatment (black sqnares) and the timing of serious vascular events (circles) for the subset of patients who withdrew from treatment because of an adverse event. Each line represents a single patient s experience over time in days for the test (left panel) and the control drug (right panel). Patients are sorted by decreased duration of treatment. In this 1 1 randomized clinical trial there were 18 withdrawals due to a severe vascular adverse event with the test drug. This is in contrast with the control drug, with 11 withdrawals. Withdrawals with the test drug occurred sooner than with the control drug.

Edgell ET, Hamilton SH, Revicki DA, et al (1998). Costs of olanzapine treatment compared with haloperidol for schizophrenia results from a randomized clinical trial. Poster presented at the 21st CINP Congress, Glasgow, July 1998. 

Grainger DL, Edgell ET, Andersen SW (1998b). Resource use and quality of life of olanzapine compared with risperidone results from an international randomized clinical trial. Abstract presented at 11th European College... 

Kent DM, Price LL, Ringleb P, Hill MD, Selker HP. Sex-based differences in response to recombinant tissue plasminogen activator in acute ischemic stroke A pooled analysis of randomized clinical trials. Stroke. 2005 36 62-65. 

Hart RG, Palacio S, Pearce LA. Atrial fibrillation, stroke, and acute antithrombotic therapy. Analysis of randomized clinical trials. Stroke 2002 33 2722-2727. 

For any intervention intended to impact favorably upon human health, it is important to evaluate its safety and efficacy in order to demonstrate that it does not cause harm and it does provide the expected benefit. The gold standard method for evaluating any intervention, whether it be a botanical product, dietary supplement, drug, medical device or medical procedure, is the randomized, clinical trial (RCT). A clinical trial is a type of experiment conducted in human subjects where the effects of at least two interventions are compared. Often, the clinical trial takes the form of an active treatment compared to an inactive control or placebo. 

MILLER ERR, APPEL L J, RISBY T H (1998) Effect of dietary patterns on measures of lipid peroxidation results from a randomized clinical trial, Circulation, 98, 2390-95. 

Nesiritide has been shown to improve symptoms of dyspnea and fatigue. In a randomized clinical trial, the safety and efficacy of adding nesiritide to standard care was compared to placebo and nitroglycerin.53 Nesiritide was found to significantly decrease PCWP more than nitroglycerin and placebo over 3 hours. Nesiritide improved patients self-reported... 

In patients with acute PE, the use of thrombolytics provides short-term benefits such as restoring pulmonary artery patency and hemodynamic stability.8,26 A recent meta-analysis of nine small randomized clinical trials showed a slightly lower risk... 

IA, condition with evidence and/or general agreement that a procedure or treatment is useful and effective, based on data from multiple randomized clinical trials IB, condition with evidence and/or general agreement that a procedure or treatment is useful and effective-based on data from a single randomized trial or nonrandomized studies. 

The choices of chemotherapy regimen, dose, schedule, and duration of therapy, as well as the choice of endocrine therapy, are controversial and rapidly changing as results from ongoing randomized clinical trials are reported. 

The randomization of a patient in a given therapy is the cornerstone of a randomized clinical trial. You may find these data in more than one place. They are often found within some form of Interactive Voice Response System (IVRS), but they may also be found in an electronic file containing the treatment assignments or on the CRF itself. If randomization data are found on the CRF, they usually consist only of the date of randomization for treatment-blinded trials. IVRS data are often found outside the confines of the clinical data management system and usually consist of the following three types of data tables. 

Treatment Effect in Randomized Clinical Trials A Meta-Analytic Evaluation, Depression and Anxiety 19 (2004) 10-19 Leo, Jonathan, Academic Freedom and Controversy over the Publication of Factually Correct, Publicly Available Information (2009) http //online.wsj.com/public/resources/documents/leo statement for WSJ.htm[25/o4/2009 17 56 46]... 

Kucuk, O., Sarkar, F.H., Sakr, W. et al. 2001. Phase II randomized clinical trial of lycopene supplementation before radical prostatectomy. Cancer Epidemiol Biomarkers Prev 10 861-868. 

Feigin VL, Doronin BM, Popova TF, Gribatcheva EV and Tchervov DV (2001). Vinpocetine treatment in acute ischaemic stroke A pilot single-blind randomized clinical trial. 

Hektoen, L., Larsen, S., Odegaard, S.A. and Loken, T. (2004), Comparison of homeopathy, placebo and antibiotic treatment of clinical mastitis in dairy cows - methodological issues and results from a randomized-clinical trial. Journal of Veterinary Medicine A Physiology, Pathology and Clinical Medicine, 51, 439-446. 

A = Data derived from multiple randomized clinical trials with large numbers of patients. 

Quality of evidence I, randomized clinical trial data II, data from clinical trials that are not randomized or were conducted in other populations III, expert opinion. 

Only clozapine has shown superiority over other antipsychotics in randomized clinical trials for the management of treatment-resistant schizophrenia. 

Dowsett M, Bundred NJ, Decensi A, Sainsbury RC, Lu Y, Hills MJ, et al. (2001) Effect of raloxifene on breast cancer cell Ki67 and apoptosis a double-blind, lacebo-controlled, randomized clinical trial in postmenopausal patients. Can Epidemiol Biomar Prev 10 961-966... 

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