Medical Writing Medical Writing in Oncology Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs
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Volume 21, Issue 1 - Medical Writing in Oncology

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.

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References

  1. Alfaro V, Cullell-Young M, Tanovic A. Abbreviated clinical study reports with investigational medicinal products for human use: current guidelines and recommendations. Croat Med J 2007;48(6):871–7. Epub 2007/12/13.
  2. ICH Topic E 3. Note for Guidance on Structure and Content of Clinical Study Reports (CPMP/ICH/137/95). 1996.
  3. Final Concept Paper E3 Q&As. E3: Structure and Content of Clinical Study Reports. Available from: http://wwwichorg/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/Concept_papers/E3_Q_As_Final_Concept_Paper_15_June_2011pdf
  4. (CHMP) CfMPfHU. Guideline on the Evaluation of Anticancer Medicinal Products in Man. CPMP/EWP/205/95/Rev.3/Corr. 2005.

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Message from the President
The war on cancer – What is the enemy, and are we winning?
Medical writing for cancer trials and submissions
Developing a treatment for ovarian cancer
The evolving landscape of medical education in oncology
Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs
Identifying appropriate journals in which to publish original research on vaccines against human infectious diseases
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