Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects

Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects

Abstract Background Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory agencies...

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Bibliographic Details
Main Authors: Dmitry Gryaznov, Ayodele Odutayo, Belinda von Niederhäusern, Benjamin Speich, Benjamin Kasenda, Elena Ojeda-Ruiz, Anette Blümle, Stefan Schandelmaier, Dominik Mertz, Yuki Tomonaga, Alain Amstutz, Christiane Pauli-Magnus, Viktoria Gloy, Karin Bischoff, Katharina Wollmann, Laura Rehner, Szimonetta Lohner, Joerg J. Meerpohl, Alain Nordmann, Katharina Klatte, Nilabh Ghosh, Ala Taji Heravi, Jacqueline Wong, Ngai Chow, Patrick Jiho Hong, Kimberly Mc Cord, Sirintip Sricharoenchai, Jason W. Busse, Arnav Agarwal, Ramon Saccilotto, Matthias Schwenkglenks, Giusi Moffa, Lars G. Hemkens, Sally Hopewell, Erik von Elm, Matthias Briel
Format: Article
Language:English
Published: BMC 2020-10-01
Series:Trials
Subjects:
Randomized clinical trials
Trial protocol
Reporting quality
Reporting guideline adherence
Registration
Trial discontinuation
Online Access:http://link.springer.com/article/10.1186/s13063-020-04808-y

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http://link.springer.com/article/10.1186/s13063-020-04808-y

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