QUASI-EXPERIMENTAL DESIGN FOR EXTERNAL CONTROL ARM STUDIES ALONGSIDE SINGLE ARM TRIALS FOR REGULATORY PURPOSES

Quasi-experimental design for external control arm studies alongside single arm trials for regulatory purposes

To accelerate new drug, biologic, and medical device development and to improve efficiency of delivery of the latest breakthroughs of innovative, life-saving treatments to millions of patients, single-arm trial (SAT) applications of rare diseases or conditions supplemented by their external control arm (ECA) evidence for regulatory approvals have b

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Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial

Abstract Background Adoption of modern contraceptive methods after menstrual regulation (MR) is thought to reduce subsequent unwanted pregnancy and abortion.Long-acting reversible contraceptives (LARCs) are highly effective at reducing unintended pregnancy, but uptake Satellite Accessories in Bangladesh is low.Providing information on the most effe

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