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
R. Schultz-Heienbrok, S. Baumann, R. Böhm, A. Bonertz, K. Breithaupt-Groegler, U. Buckpesch-Heberer, M. Coenen, K. Erb-Zohar, N. Faisst, G. Grass, J. Höchel, A. Kovar, A. Muehlenbroich, J. Rengelshausen, C. Riedel, B. Schug, T. Sudhop, A. Warnke, B. Ziegele · 2026
Read 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 by R. Schultz-Heienbrok, S. Baumann, R. Böhm, A. Bonertz, K. Breithaupt-Groegler, U. Buckpesch-Heberer, M. Coenen, K. Erb-Zohar, N. Faisst, G. Grass, J. Höchel, A. Kovar, A. Muehlenbroich, J. Rengelshausen, C. Riedel, B. Schug, T. Sudhop, A. Warnke, B. Ziegele (2026) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-12883952.txt.
Description
Schultz-Heienbrok and a large co-author group present, in a 2025 consensus paper, a practical design for early drug trials that fold several stages into one protocol. Frequent major amendments slow development and cloud transparency. Mixing healthy volunteers and patients in one trial raises its own safety and regulatory questions.
Stakeholders in Germany agreed on pathways for smooth, predefined transitions inside a single protocol. European guidance allows the switches when scope, safety limits, and decision rules are fixed in advance. The scope covers non-oncology trials of standard drug types. Fewer restarts mean faster answers about new medicines and less duplicated screening of volunteers.
Catalog record
| CREATOR | R. Schultz-Heienbrok, S. Baumann, R. Böhm, A. Bonertz, K. Breithaupt-Groegler, U. Buckpesch-Heberer, M. Coenen, K. Erb-Zohar, N. Faisst, G. Grass, J. Höchel, A. Kovar, A. Muehlenbroich, J. Rengelshausen, C. Riedel, B. Schug, T. Sudhop, A. Warnke, B. Ziegele |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 36 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |