The integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) are important parts in clinical trials. In general, when applying for clinical research, the researchers should combine the pharmacy characteristics of the drug, the pharmacological and toxicological research results, the clinical indications, the population for taking drugs and the clinical trial literature, thus they conduct a comprehensive analysis of the feasibility, safety and effectiveness of clinical research on the drug, and propose the safety issues that need to be paid attention to in clinical research and the safety indicators that need to be monitored. The focus of ISS and ISE is on the overall understanding of the effectiveness and safety of the drug under study, based on a complete understanding of the results of drug research.
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Our statistical experts will help you to develop a clear and logical ISS and ISE study to conduct a comprehensive analysis of the feasibility, safety and effectiveness of clinical research on the drug. To achieve that, the study design of ISS and ISE for the various clinical trials below constitutes most of our work:
The clinical validity data of the target indication population of drug we studied must be sufficiently complete. The effectiveness evaluation should consider a variety of factors, such as the characteristics of the test population, the relationship between efficacy and dosage, the method of administration, and the clinical significance of the results. In the study design of the trial, we take multiple factors into account such as patient enrollment, study achievement, control group and endpoint selection for you to evaluate the effectiveness.
Important safety analyses should consider the following factors:
(1) Adverse reactions related to the pharmacological classification of the study drug
(2) Special adverse reactions (such as arrhythmia, prolonged QT interval)
(3) Characteristics of the test population and exposure of the test group and the control group
(4) Relationship between adverse reactions and doses interval and duration of administration
(5) Long-term medication safety
When making overall evaluation of a study, we will consider all the factors mentioned above, and make a comprehensive evaluation.
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References:
1. Grellety, T., Petitmonéger, A., Diallo, A., Mathoulinpelissier, S., & Italiano, A. (2014) ‘Quality of reporting of phase ii trials: a focus on highly ranked oncology journals’, Annals of Oncology, 25(2), 536-541.
2. Perry, B. H., Sampson, A. R., Schwab, B. H., Karim, M. R., & Smiell, J. M. (2002) ‘A meta-analytic approach to an integrated summary of efficacy: a case study of becaplermin gel’, Controlled Clinical Trials, 23(4), 389-408.