Risk-of-Bias Assessment of Target Trial Emulation Studies at Regulatory and Policy Decision Points Along the Medical Product Life Cycle: Protocol for a Scoping Review and Stakeholder Survey

Anni Kokolahti   ¹ , MSc ;   Saara Puustinen   ¹ , MSc ;   Martin Russek   ² , MSc ;   Christoph Röthlein   ² , PhD ;   Cornelia Becker   ² , PhD ;   Jonas Peltner   ² , PhD ;   Ines Costa   ³ , MSc ;   Sirpa Hartikainen   ¹ , MD, PhD ;   Britta Haenisch   ^{2, 4, 5} , PhD ;   Cláudia Furtado   ^{3, 6} , PhD ;   Anna-Maija Tolppanen   ¹ , PhD ;   Christina Tikka   ¹ , PhD

¹ School of Pharmacy, University of Eastern Finland, Kuopio, Finland

² Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany

³ Portuguese National Authority of Medicines and Health Products (Infarmed), Lisbon, Portugal

⁴ German Center for Neurodegenerative Diseases, Bonn, Germany

⁵ Center for Translational Medicine, University of Bonn, Bonn, Germany

⁶ NOVA National School of Public Health, NOVA University Lisbon, Lisbon, Portugal