Multi-center trials

There are other trial design concepts for you to be aware of. A clinical trial can be carried out at a single site or it can be a multi-center trial. In a single-site trial all of the patients are seen at the same clinical site, and in a multi-center trial several clinical sites are used. Multi-center trials are needed sometimes to eliminate site-specific bias or because there are more patients required than a single site can enroll. 

Guelfi JD, Pichot P, Dreyfus JF Efficacy of tianeptine in anxious depressed patients results of a multi-center trial versus amitriptyline. Neuropsychobiology 22 41-48, 1989... 

Fischer-Cornelssen KA, FernerUJ. An example of European multi-center trials multispectral analysis of clozapine. Psychopharmacoi Bull 1976 12 34-39. 

The U.S. Xyrem study group (2002) A randomized, double blind, multi center trial comparing the effect of 3 doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep 25 42-49... 

Once the initial safety/tolerability of the investigational drug has been demonstrated in the initial Phase I trials, the compound is progressed into Phase II trials. These studies are performed in larger, quite often multi-center trials in the target patient population with the objective of providing so-called proof of concept information. The number of patients to be enrolled into these phase II trials is very much dependent on the therapeutic area and can range from 50-200 patients up to several hundreds. 

Heck AH, Haffmans PM, de Groot IW, Hoencamp E. Risperidone versus haloperidol in psychotic patients with disturbing neuroleptic-induced extrapyramidal symptoms a double-blind, multi-center trial. Schizophr Res 2000 46(2-3) 97-105. 

Kasper S, Anghelescu IG, Szegedi A, Dienel A, Kieser M. Superior efficacy of st. John s wort extract WS 5570 compared to placebo in patients with major depression a randomized, double-blind, placebo-controlled, multi-center trial. BMC Med. 2006 4 14. 

Methotrexate and misoprostol for early abortion a multi-center trial. I. Safety and efficacy. Contraception 1996 53(6) 321-7. 

Metcalf TJ, Irons TG, Sher LD, Young PC. Simethicone in the treatment of infant colic randomized, placebo-controlled, multi-center trial. Pediatrics 1994 84 29—34. 

Chuang-Stein C (1992). Summarizing laboratory data with different reference ranges in multi-center trials. Drug Information / 26 74-84. 

Rex JH, Pappas PG, Karchmer AW, et al. A randomized and blinded multi center trial of high-dose fluconazole plus placebo versus fluconazole plus amphotericin B as therapy for candidemia and its consequences in nonneutropenic subjects. Clin Infect Dis 2003 36 1221-1228. 

Member States are to establish procedures for managing multi-center trials limited to the territory of a single MS, irrespective of the number of IEC, in order to adopt a single... 

Coumarin has undergone a double-blinded, placebo-controlled trial for RCC and 7-hydroxycoumarin (1) is in phase I clinical trial for this purpose [177]. Recently, xanthotoxin has also been used in the treatment of cancer [178, 179]. Studies have been initiated in two multi-center trials of 1 g coumarin daily. Metastatic prostatic carcinoma patients of normal performance status were treated in a phase II trial [180]. 

Kahn R, Biswas K, Childress AR. Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent... 

Wu SX, Cui TT, Zhao C, Pan JJ, Xu BY, Tian Y, Cui NJ. A prospective, randomized, multi-center trial to investigate Acto-vegin in prevention and treatment of acute oral mucositis caused by chemoradiother-apy for nasopharyngeal carcinoma. Radio-ther Oncol 2010 97(1) 113-8. 

The best trial so far was done by Dold et al. [75]. In a randomized multi-center trial they assessed the effects of Iscador with a multivitamin preparation (as a placebo) in 408 patients with advanced non-small-cell bronchial carcinoma. The median survival time was 9.1 and 7.6 months for the Iscador and placebo groups, respectively. The difference is not statistically significant but has a positive trend for the Iscador group [74]. 

Cooperation Group for Phase IV Clinical Study of Levofloxacin. The clinical efficacy and safety of intravenous levofloxacin in the treatment of4888 patients with bacterial infections a multi-center trial. Zhonghua Nei Ke Za Zhi 2009 48(6) 492-6. 

Nolte F, Hochsmann B, Giagounidis A, Lubbert M, Platzbecker U, Haase D, et al. Results from a 1-year, open-label, single arm, multi-center trial evaluating the efficacy and safety of oral deferasirox in patients diagnosed with low and int-1 risk myelodysplastic syndrome (MDS) and transfusion-dependent iron overload. Ann Hematol January 2013 92(2) 191-8. 

Multi-center trials establish safety and efficacy of tretinoin emollient cream for treatment of photoaging... 

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