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The heterogeneity of symptom reporting across study sites: a secondary analysis of a randomised placebo-controlled multicentre antimalarial trial

Abstract Introduction Symptoms reported following the administration of investigational drugs play an important role in decisions for registration and treatment guidelines. However, symptoms are subjective, and interview methods to quantify them are difficult to standardise. We explored differences...

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Principais autores: Kamala Thriemer, Robert James Commons, Megha Rajasekhar, Tamiru Shibiru Degaga, Krisin Chand, Nguyen Hoang Chau, Ashenafi Assefa, Mohammad Nader Naddim, Ayodhia Pitaloka Pasaribu, Awab Ghulam Rahim, Inge Sutanto, Tran Tinh Hien, Asrat Hailu, Mohammad Anwar Hasanzai, Lenny L. Ekawati, Adugna Woyessa, Tedla Teferi, Naomi Waithira, Walter R. J. Taylor, Benedikt Ley, Arjen Dondorp, J. Kevin Baird, Nicholas J. White, Nicholas P. Day, Ric N. Price, Julie A. Simpson, Lorenz von Seidlein
Format: Artigo
Sprog:Inglês
Udgivet: BMC 2023-09-01
Serier:BMC Medical Research Methodology
Fag:
Clinical trial
Safety
Tolerability
Symptom reporting
Trial design
Online adgang:https://doi.org/10.1186/s12874-023-02022-3
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