Making do without randomised trials

Do single‐arm trials have a role in drug development plans incorporating randomised trials?

Often, single-arm trials are used in phase II to gather the first evidence of an oncological drug's efficacy, with drug activity determined through tumour response using the RECIST criterion. Provided the null hypothesis of 'insufficient drug activity' is rejected, the next step could be a randomised two-arm trial. However, single-arm trials may provide a biased treatment effect because of pati...

Introducing “Agreement on what to Measure in Randomised Controlled Trials in Burn Care” Research Project

پروژه پژوهشی "توافق درباره‌ی پیامدهای قابل اندازه‌گیری در کارآزمایی های کنترل‌دار مربوط به مراقبت‌های سوختگی" توسط گروهی از پژوهش‌گران با تجربه، در حوزه سوختگی، زیر نظر دکتر Young از کشور انگلستان در حال انجام می‌باشد. هدف نهایی از انجام این مطالعه، تهیه و تدوین مجموعه‌ای از پیامدهای اساسی (core outcome set (COS)) است که در گزارش کارآزمایی های شاهد‌دار تصادفی مربوط به مراقبت‌های سوختگی باید مور...

Randomised trials and ribavirin.

with severe respiratory syncytial virus infection. Crit Care Med 1987;15:1051-4. 13 Gelfand EW, McCurdy D, Pandu Rao C, Middleton PJ. Ribavirin treatment of viral pneumonitis in severe combined immunodeficiency disease. Lancet 1983;ii:732-3. 14 McIntosh K, Kurachek SC, Cairns LM, Burns JC, Goodspeed B. Treatment of respiratory viral infection in an immunodeficient infant with ribavirin aerosol....

Randomised controlled trials.

Cluster randomised trials.

Although randomised controlled trials are the reference methodology to assess the effects of therapeutic interventions, for interventions that naturally occur in groups of individuals random allocation of participants may be inappropriate. In these cases, the unit of random allocation may be the group or cluster, rather than the individual. Clinical trials that randomly allocate groups or clust...