Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs

Abstract

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including modifications to the table of contents and adding, deleting, or rearranging some of the contents defined by the guideline to better display the results and improve the communication of information. One example is the Safety Evaluation section of CSRs for studies with anticancer drugs. A more logical, reader-friendly way of showing data is to reverse the order and numbering of the Safety and Evaluation sections, presenting Safety Evaluation as Section 11 (main endpoints are all of them safety variables) and Efficacy Evaluation as Section 12. In addition, phase I CSRs in oncology require new sections describing results regarding main endpoints: i.e., dose-limiting toxicities, the maximum tolerated dose, and recommended dose for phase II trials. Finally, adverse events that can be measured as laboratory abnormalities (e.g. neutropenia, thrombocytopenia, transaminase increases, etc.) may be underreported if they are only listed based on the adverse events rows of the case report form. Hence, laboratory abnormalities are better reported by objective laboratory results.

Keywords:

• Clinical study reports
• Phase I
• Safety
• Dose-limiting toxicities
• Recommended dose
• Oncology

Additional information

Notes on contributors

Vicente Alfaro

Vicente Alfaro holds a Ph.D. in Biology, a PgC in Pharmacology/Pharmacoeconomics, and an MsC in Immunology (University of Barcelona, U.B.). He is an Associate Professor (U.B., 1991–2007), Head of Medical Writing since 1996 (Biomedical Systems Group, Prous Science and PharmaMar) and author of more than 80 peer-reviewed articles. He is also holds membership to AERTeM, EMWA, TIPPA and ISMPP.