Application of the IPDfromKM-Shiny Method to Compare the Efficacy of Novel Treatments Aimed at the Same Disease Condition: A Report of 14 Analyses

SIMPLE SUMMARY: The clinical development of new cancer drugs is based on clinical trials that compare the new drug with the one representing the standard of care. However, it takes some time for the new drug to become available for patient use. In the meantime, the standard of care may have been updated and therefore the efficacy of the new drug needs to be tested against the new standard of care. This objective is usually pursued by performing indirect comparisons: since no “real” trial is available comparing the new drug with the new standard of care, this comparison is carried out by means of a simulated trial wherein patients of real trials are reconstructed individually, pooled together according to an original design of comparison, and finally subjected to standard statistics. Previously published trials are used to perform this comparison. We describe a new method to perform these indirect comparisons, called the IPDfromKM-Shiny method, that lies midway between simple interpolation and advanced statistics. More than 10 investigations have already been conducted in which this method has been used to perform indirect comparisons, especially in the area of haemato-oncology. In the light of these preliminary experiences, the IPDfromKM-Shiny method is proving to be a valid advancement for conducting comparative research in the area of evidence-based medicine. ABSTRACT: In the area of evidence-based medicine, the IPDfromKM-Shiny method is an innovative method of survival analysis, midway between artificial intelligence and advanced statistics. Its main characteristic is that an original software investigates the Kaplan-Meier graphs of trials so that individual-patient data are reconstructed. These reconstructed patients represent a new form of original clinical material. The typical objective of investigations based on this method is to analyze the available evidence, especially in oncology, to perform indirect comparisons, and determine the place in therapy of individual agents. This review examined the most recent applications of the IPDfromKM-Shiny method, in which a new web-based software—published in 2021—was used. Reported here are 14 analyses, mostly focused on oncological treatments. Indirect comparisons were based on overall survival or progression free survival. Each of these analyses provided original information to compare treatments with one another and select the most appropriate depending on patient characteristics. These analyses can also be useful to assess equivalence from a regulatory viewpoint. All investigations stressed the importance of heterogeneity to better interpret the evidence generated by IPDfromKM-Shiny investigations. In conclusion, these investigations showed that the reconstruction of individual patient data through this online tool is a promising new method for analyzing trials based on survival endpoints. This new approach deserves further investigation, particularly in the area of indirect comparisons.