Efficient risk mitigation planning for a clinical trial
M Shnaydman, V.
Show abstract
Each clinical trial faces numerous risks. Neglecting or reacting spontaneously at each materialized risk may delay trial completion, affect trial objectives and even derail the clinical trial. At the same time, pre-allocating excessive contingency resources to eliminate all potential risks, even with a low probability of occurrence and impact, may not be necessary. Therefore, optimal risk planning means finding the "right" balance between contingency resources, risk mitigation strategy, and risk tolerance. Most risk planning publications focus only on risk identification and risk assessment. Risk mitigation strategy planning is often overlooked. A contingency budget is routinely assigned as a percentage of a clinical trial budget, e.g., 10-20%, and is not aligned with the clinical trial risk level. Therefore, to derive an effective clinical trial risk mitigation strategy, a new methodology based on mathematical modeling was developed and validated for a Ph2 clinical trial.
Matching journals
The top 5 journals account for 50% of the predicted probability mass.
Similar papers in this journal
- Using numerical modelling and simulation to assess the ethical burden in clinical trials and how it relates to the proportion of responders in a trial sample 95%
- An interactive retrieval system for clinical trial studies with context-dependent protocol elements 95%
- A method of back-calculating the log odds ratio and standard error of the log odds ratio from the reported group-level risk of disease 93%
Similar papers in this journal
- Inverse planning for radiofrequency ablation in cancer therapy using multiple damage models 89%
- Strict lockdown versus flexible social distance strategy for COVID-19 disease: a cost-effectiveness analysis 88%
- Normalized Semi-Covariance Co-Efficiency Analysis of Spike Proteins from SARS-CoV-2 variant Omicron and Other Coronaviruses for their Infectivity and Virulence 88%
Similar papers in this journal
Similar papers in this journal
- Modelling vaccination capacity at mass vaccination hubs and general practice clinics 91%
- ‘Leading from the front’ implementation strategies increase the success of influenza vaccination drives among healthcare workers: A reanalysis of Systematic Review evidence using Intervention Component Analysis (ICA) and Qualitative Comparative Analysis (QCA) 90%
- The Impact for implementing Balanced Scorecard in Health Care Organizations: A Systematic Review 90%
Similar papers in this journal
- Staffing and Capacity Planning for SARS-CoV-2 Monoclonal Antibody Infusion Facilities: A Performance Estimation Calculator based on Discrete-Event Simulations 93%
- Machine Learning Based Clinical Decision Support System for Early COVID-19 Mortality Prediction 92%
- Evaluation of a clinical decision support system for detection of patients at risk after kidney transplantation 92%
"Similar papers" are the closest papers from that journal in the model's embedding space. They show what the match is built on, but the ranking comes mostly from a classifier over the whole training set, not from these examples alone.