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P110: Clinically Relevant Analysis of Safety Data from Clinical Studies utilising Burden of Therapy, Both Methodology

Poster Presenter

Ayad Abdul-Ahad

Chief Executive Officer
BOTH Analytics GmbH
United Kingdom

Objectives

Analysis of study safety data in all dimensions, time, duration, frequency & severity in every subject. BOTh utilizes patient-level routinely collected data to quantify the daily burden of AEs for all or individual subjects & can be applied retrospectively or prospectively data on clinical studies

Method

BOTh utilizes AE duration, a weight for severity amplifies more severe events for daily toxicity burden per subject and population expressed in a chart. The sum of daily burdens expressed as the AUC for the whole study period, with its inferential statistics to investigate treatment differences

Results

BOTh has been applied retrospectively & prospectively to data from a number of clinical studies including those in colorectal cancer, pancreatic cancer, prostate cancer, melanoma, uveal melanoma, neuropathic pain and hyperactive bladder. daily toxicity burden per subject and population expressed in a chart. The sum of daily burdens were expressed as the AUC on a daily basis for single patients and study groups, for the whole study period This allowed for inferential statistics to reveal treatment differences between study groups. BOTh analyses revealed new safety aspects, provided clinically relevant endpoints & addressed safety concerns for patients, clinicians, payers, and regulators, utilising its novel BOTh visual & statistical outputs. BOTh revealed Healthcare Resource Utilisation & Safety Benefits and enhanced therapeutic decisions for, Physicians, Regulators, payers & patients. BOTh generated meaningful safety data from clinical studies, & an outlook on QoL.

Conclusion

The Burden of Therapy (Both) method is a unique way of analyzing event data that allows investigating all these dimensions simultaneously. Utilises routinely collected data & can be applied retrospectively or prospectively. BOTh utilises patient-level safety data to quantify the burden of AEs that all or individual patients experience on each day of a clinical study. A chart displays the total burden experienced by patients on each day throughout the study. Statistical analyses can be performed with the area under curve. The method looks at each study day which event was present (making use of the start and end dates in the event collection). A weight for severity can be used to amplify more severe events. On each study day, one can derive the toxicity burden on each patient; summing the burden and correcting it by the number of patients in the trial will give a population burden. The population burden can be interpreted as the daily average number of weighted events. As each day has its own burden, the sum of daily burdens can be seen as the AUC for the whole study period, and inferential statistics on this AUC can be used to investigate treatment effects & differences. BOTh gives insight into how multiple conditions develop over time in a study and accurately reflects patients’ experience by these conditions on each day of the trial. BOTh has been applied to a number of clinical trial data, revealing new safety aspects. It provides Clinically Relevant Endpoints & addresses Safety concerns. Payers, Healthcare Resource Utilisation & Safety Benefits. Explains safety to physicians & patients