Contemporary clinical trials
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Contemp Clin Trials · Jul 2012
Randomized Controlled TrialAn online randomised controlled trial to assess the feasibility, acceptability and potential effectiveness of 'Living with Bipolar': a web-based self-management intervention for bipolar disorder: trial design and protocol.
Bipolar Disorder (BD) is a common and severe form of mental illness. Pharmacotherapy is the main treatment offered, but has limited effectiveness, and there is increasing evidence that people with BD respond well to psychological interventions. Inequalities in access to face-to-face psychological interventions mean many people seek support outside of routine health services. ⋯ The results of this trial will inform a definitive trial; and the implementation phase will aim to assess the potential for use within the NHS.
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Contemp Clin Trials · Jul 2012
Comparative StudyDose-finding designs in pediatric phase I clinical trials: comparison by simulations in a realistic timeline framework.
Usual dose-finding methods in oncology are sequential. Accrual is suspended after each group of patients to assess toxicity before increasing the dose. An adapted Continual Reassessment Method (CRM) and Rolling 6 (R6) method, designed to avoid this suspension of accrual in pediatric oncology, are compared with the traditional 3+3 design. ⋯ These new methods can reduce the number of skipped patients, but only provide limited gain in terms of ability to select the right dose. New designs are needed.