Clinical trials comparators

Table ii.6 shows types of peels used to treat acne and their indications. Unfortunately there are no conclusive clinical trials comparing chemical peels with standard acne therapy in terms of efficacy and tolerability... 

Breneman DL, Stewart D, Hevia O, Hino PD, Drake LA (1998) A double-blind, multicenter clinical trial comparing efficacy of once-daily metronidazole 1% cream to vehicle in patients with rosacea. Cutis 61 44-47... 

Hrobjartsson, A. and P. C. Gotzschc, An Analysis of Clinical Trials Comparing Placebo with No Treatment , New England Journal of Medicine 344 (2001) 1594-602... 

Spinal surgery 5. aureus, S. epidermidis Cefazolin 1 g x 1 Limited number of clinical trials comparing different treatment regimens IB... 

Local injection site reactions The most common adverse events associated with enfuvirtide use are local injection site reactions. Manifestations may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, and ecchymosis. Pneumonia An increased rate of bacterial pneumonia was observed in subjects treated with enfuvirtide in the phase 3 clinical trials compared with the control arm. Hypersensitivity reactions Hypersensitivity reactions have been associated with enfuvirtide therapy and may recur on rechallenge. Hypersensitivity reactions have included individually and in combination Rash, fever, nausea and vomiting, chills. 

Soresi E, Clerici M, Grilli R, et al. A randomized clinical trial comparing radiation therapy versus radiation therapy plus cis-dichlorodiammine platinum in the treatment of locally advanced non-small cell lung cancer. Semin Oncol 1988 15 20-25. 

Lebeau B, Urban T, Brechot JM, et al. A randomized clinical trial comparing concurrent and alternated thoracic irradiation for patients with limited small-cell lung carcinoma. Cancer 1999 86 1480-1487. 

Knott JC, Taylor DM, Castle DJ. Randomized clinical trial comparing intravenous midazolam and droperidol for sedation of the acutely agitated patient in the emergency department. Ann Emerg Med 2006 47 61-67. 

In Section 3.2.2 we presented data from a clinical trial comparing trastuzumab to observation only after adjuvant chemotherapy in HER2-positive breast cancer. The incidence rates in the test treatment and control groups were respectively 7.0 per cent and 4.7 per cent. 

The information presented in this section provides the background for later sections, which will quantitatively summarize the controlled literature for the various classes of psychotropics. In all cases, the data were obtained from controlled, clinical trials comparing a new (or experimental) treatment with placebo or a standard agent. The goal of these summations is to give a reader the critical bottom line, devoid of our subjective bias, as well as the bias from isolated publications inconsistent with the trend seen when the controlled data are combined. 

Nair NPV, Suranyi-Cadotte B, Schwartz G, et al. A clinical trial comparing intramuscular haloperidol decanoate and oral haloperidol in chronic schizophrenic patients efficacy, safety, and dosage equivalence. J Clin Psychopharmacol 1986 6(suppl 1) 30S-37S. 

Although the early clinical trials comparing SSRIs with tertiary amine TCAs found the newer agents to have better tolerated side-effect profiles, these differences were less evident when they were compared with secondary amine TCAs (433, 434, 435, 436, 437 and 438). The most important advantage of the SSRIs is the absence of severe adverse effects (e.g., cardiac conduction delays, seizures, postural hypotension) and death from overdose. 

Chang P, Kenley S, Burns T, Denton G, Currie K, DeVane G, O Dea L. Recombinant human chorionic gonadotropin (rhCG) in assisted reproductive technology results of a clinical trial comparing two doses of rhCG (Ovidrel) to urinary hCG (Profasi) for induction of final follicular maturation in in vitro fertilization-embryo transfer. Fertil Steril 2001 76(l) 67-74. 

Senagore AJ, Delaney CP, Mekhail N, et al. Randomized clinical trial comparing epidural anaesthesia and patient-controlled analgesia after laparoscopic segmental colectomy. BrJ Surg. 2003 90 1195-1199. 

Leon MS, Bairn DS, Popma JJ, et al. A clinical trial comparing three antithrombotic drug regimens after coronary artery stenting. N Engl J Med 1998 339 1665-1671. 

While phase 1 trials often include patients of different treatment backgrounds and, depending on the mechanism of action of the experimental therapeutic, may include many different tumor types (e.g., an all-comers scenario), pivotal clinical trials are more tightly controlled in order to maximize the opportunity to detect an efficacy signal. As mentioned previously, the earliest pivotal clinical trials compare SOC alone and SOC in combination with experimental therapy to determine whether the experimental therapeutic provides additional patient beneht. Once this incremental beneht is demonstrated, additional clinical trials may be conducted to determine whether the experimental therapy is benehcial in earlier stage disease (e.g., the adjuvant... 

In addition to demonstrating safety, shock advocates would also have to prove efficacy through double-blind clinical trials comparing ECT to sham or placebo in which the subject is put to sleep without the actually administering the shock. Thus far, placebo-controlled trials have failed to show any significant superiority of ECT over sham ECT. 

As noted previously, the FDA has recently clarified the requirements for an IND intended for phase 1 clinical trials compared with trials that are designed for phase 2 or 3 clinical programs. Table 1 provides information regarding the differences between the phases of investigation with respect to the size and scope of the particular phase. A more detailed description of the phases of investigation may be found in 21 CFR Part 312.21. 

Guelfi JD, Dreyfus JF, Pichot P. A double-bhnd controlled clinical trial comparing fluvoxamine with imipramine. Br J Chn Pharmacol 1983 15(Suppl. 3) 411S-7S. 

Ancolio C, Tardieu S, Soubrouillard C, Alquier C, Pradel V, Micallef J, Blin O. A randomized clinical trial comparing doses and efficacy of lormetazepam tablets or oral solution for insomnia in a general practice setting. Hum Psychopharmacol 2004 19 129-34. 

A phase I/II randomized clinical trial compared ranibizumab injections, given at 4-week intervals, with usual care (control arm) in 64 subjects with predominantly classic or minimally classic AMD. The drug appeared to be effective for both types of AMD as evidenced by improvements in visual acuity at 3 and 6 months and was found to have an acceptable tolerability profile. Subjects with less than 15 letters of acuity at the end of the phase I/II study were followed for over 1 year, but the fixed dosing interval of every 4 weeks was relaxed to a more flexible strategy of holding a dose if acuity was stable (with a change of less than 5 letters) and lesion characteristics were stable on two consecutive visits. Acuity and lesion characteristics continued to be stable in subjects, and the median dosing rate of 1.0 injection every 4 weeks decreased to 0.22 injections every 4 weeks. 

Hrobjartsson A, Gotzsche P C 2001 Is the placebo powerless An analysis of clinical trials comparing placebo with no treatment. New England Journal of Medicine 344 1594-1602... 

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