Participant randomisation

Cholesterol Treatment Trialists (CTT) Collaborators (2005) Efficacy and safety of cholesterol-lowering treatment prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins. Lancet 366 1267-1278... 

Antipsychotics may be widely used in the treatment of elderly people with schizophrenia, however, based on this systematic review, there are little robust data available to guide the clinician with respect to the most appropriate drug to prescribe. Clearly reported large short, medium and long-term randomised controlled trials with participants, interventions and primary outcomes that are familiar to those wishing to help elderly people with schizophrenia are long overdue. 

A Cochrane Review of 20 randomised controlled trials involving 280 participants, showed that 4 mg, of nedocromil sodium inhaled 15-60 minutes prior to exercise significantly reduces the severity and duration of exercise-induced bronchus constriction in both adults and children, when compared to placebo. This effect appears to be more pronounced in people with severe exercise-induced bronchoconstriction. 

Prien et al. (1973) 205 participants, recently manic, 2-year follow-up Lithium vs placebo 100% (all patients stabilised on lithium prior to randomisation)... 

Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R (2010) Efficacy and safety of more intensive lowering of LDL cholesterol a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 376 1670-1681... 

In intention-to-treat (ITT) analysis all randomised participants are included, i.e. 

Coleman, R.E., Banks, L.M., Girgis, S.I., Kilbum, L.S., Vrdoljak, E Fox, J., Cawthom, S.J., Patel, A., Snowdon, C.F., Hall, E., Bliss, J.M. and Coombes, R.C. (2007) Skeletal effects of exemestane on bone-mineral density, bone biomarkers, and fracture incidence in postmenopausal women with early breast cancer participating in the Intergroup Exemestane Study (IES) a randomised controlled study. The Lancet Oncology, 8, 119-127. 

The prerequisite for an ethical randomised control trial is that it provides no certain benefit to the individual patients and in fact could harm the child as the result of potential side effects. Research is justified when there is no convincing ground that any patient would be advantaged or disadvantaged if allocated to one treatment arm over the others (Freedman, 1987a). It has been shown that research participants often fail to understand that their treatment has been selected at random... 

Parents have different reasons for allowing their children to participate in clinical research. A researcher should understand these factors and take them into account in trial design and parent/patient education. The aim is to improve the recruitment rate, on the one hand, and parentsVpatients satisfaction, on the other. Less well-informed parents may misconstrue that their child will get better treatment or will get a novel treatment in a randomised trial and will be disappointed when the result or randomisation does not correspond to their perception. Fundamentally, such a misunderstanding threatens their ability to make an informed choice. 

Schmidt B, Gille P, Caco C, et al. (1999). Do sick newhom infants henefit from participation in a randomised clinical trial J Pediatr 134 151-155. 

The survey was presented using PPT slides. It consisted of two major parts, viz. individual evaluation and comparison evaluation. In individual evaluation, participants evaluated the design concepts one by one and they were told not to compare the six biscuit containers. The sequence of the biscuit containers appearing in the survey is randomised to reduce bias. The first part of the survey, i.e., individual evaluation, covered the following six aspects. 

Drug formulation Pharmacokinetics and bioavailability of parental diazepam were compared with two novel intranasal diazepam formulations (intranasal solution and intranasal suspension) in a randomised, open-label, pilot study in 24 healthy volxmteers [9 ]. Participants received two intranasal and one intravenous dose of diazepam with 2 weeks washout period between doses. Both intranasal formulations were well tolerated. Diazepam concentration... 

Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron J A, et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs meta-analyses of individual participant data from randomised trials, lancet August 31,2013 382(9894) 769-79. 

Finally, an investigation of the effectiveness of ulfrasound-guided corticosteroid injection for the treatment of plantar facilities was conducted by a randomised investigator- and participant-blinded, placebo-controlled trial 82 people with a clinical and ultrasoxmd diagnosis of planfar fasciitis unrelated to systemic inflammatory disease were examined. The participants were randomly allocated to ultrasound-guided injection of the plantar fascia with either 1 ml of 4 mg/ml dexamefhasone sodium phosphate (experimental group) or 1 ml normal saline (placebo) [70 -]. 

The serious adverse effects of salmeterol when added to ICS, in asthmatic adults and children, were assessed by another Cochrane meta-analysis [36 ]. The meta-analysis included 40 randomised controlled trials studies, with a total population of 15,309 participants and was foxmd to have a low risk of bias. Salmeterol with ICS was not associated with mortality (adults Peto OR = 0.90, 95% Cl = 0.31, 2.60, children no reported deaths). Furthermore, there was no significant association between salmeterol with ICS and the risk of serious adverse effects, in adults (Peto OR = 1.15,95% Cl = 0.91,1.44), or in children (Peto OR = 1.20,95% Cl = 0.37,3.91). No between-group difference was found in asthma-related serious adverse effects in those receiving salmeterol with ICS compared to ICS only (adults Peto OR = 1.12,95% Cl = 0.65,1.94. Children only one asthma related event in each group). 

The study cohort was derived from 33,357 ALLHAT participants, who were aged 55 years or older, had hypertension and at least one additional cardiovascular disease risk factor. The participants who were normokalemic at baseline were randomised to chlorthalidone versus amlodipine or lisinopril and were stratified by level of potassium at year 1 into hypokalemia (<3.5 mmol/L) normokalemia (3.5-5.4 mmol/L) and hyperkalemia (>5.4 mmol/L). Incidence of hypokalemia in chlorthalidone was 12.9% and this differed significantly from amlodipine (2.1%, p < 0.001) and lisinopril (1.0%, p < 0.01). Incidence of hyperkalemia was greatest in lisinopril arm (3.6%) than in chlorthalidone arm (1.2%, p < 0.01) or amlodipine (1.9%, p < 0.01). Coronary heart disease occurred in 8.1%, 8.0% and 11% in patients with hypokalemia, normokalemia and hyperkalemia, respectively. 

Placebo-controlled studies A placebo-controlled study evaluated the safety and efficacy of topical cidofovir in preventing beard hair growth in healthy men (n = 20) [ll ]. Participants received cidofovir (randomised to either 1% or 3%) and placebo, each applied to one side of the face after shaving (the side allocation was randomised), for either 6 or 8 weeks. There were adverse events reported in 12 subjects the most frequent was upper respiratory tract infection (n=4), and erythema or hyperpigmentation (n = 3), or local pruritus (n = 2). The local skin reactions were all mild and most resolved spontaneously within 8 weeks of the end of treatment. There were no significant changes in blood urea nitrogen or creatinine levels in this small study. 

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