Research graph
References from Designing integrated early-phase protocols to reduce substantial modifications, including considerations for patient cohorts – a multi-stakeholder consensus view for a practical approach in Germany. Local targets link to admitted publications; unresolved targets remain external evidence.
Recommendations on complex clinical trials in mono-national clinical trials in the early development phase (early phase Complex clinical trials)
2024 · External reference
Recommendation paper on the initiation and conduct of complex clinical trials
2019 · External reference
Use of integrated protocols – a survey in early medicines development
10.5414/cp203206 · 2018 · External reference
Unresolved reference
External reference
Clinical trials regulation (EU) no 536/2014 questions & answers
2025 · External reference
Guideline on data monitoring committees
2005 · External reference
Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products (revision 1)
2017 · External reference
EMA policy 0070 guidance: transparency in clinical data publication
2025 · External reference
Unresolved reference
2024 · External reference
Analysis of integrated clinical trial protocols in early phases of medicinal product development
10.1007/s00228-017-2335-y · 2017 · External reference
Re-inventing clinical trials through TransCelerate
10.1038/nrd4437 · 2014 · External reference
Unresolved reference
External reference
ICH E8(R1): general considerations for clinical trials
2021 · External reference
ICH M11: clinical electronic structured harmonized protocol (CeSHarP). M11 template
2022 · External reference
Unresolved reference
2025 · External reference
Common terminology criteria for adverse events (CTCAE) version 5.0
2017 · External reference
