Bayesian Adaptations in Oncology Studies
Genpro’s experience in Dose Escalation Oncology trials include, designing studies to understand and identify the dose limiting toxicities (DLT's) and recommended phase II dose (RPTD). We can also help you understand the toxicity profile and PK/PD of a new therapy or combination. The objective of one of the recent studies was to reach the DLT and find the MTD (Maximum tolerated dose) and RPTD for single targeted agent in solid tumor (Gastric Cancer).
Continuous Reassessment Design
MTPI (Modified Toxicity Probability Interval) approach
Simulation for predicting the DLT and to get to the RPTD.
PK/PD Analysis in Hematology
Genpro Research can perform quantitative analyses on PK Parameters. Our biostatistics team can also provide complex PK/PD analyses for both clinical and preclinical studies. One of the recent hematology study objectives was to compute the coverage of drugs in plasma, required to attain 50% of the PD activity. Analysis was performed by fitting a proper nonlinear regression model using PROC NLIN in SAS. All PK/PD analyses are performed using SAS and validated using R Programs.
Appropriate variation reduction techniques
Visualise the predicted response value
Assessment of lag in plasma compound concentration
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Well defined SOPs
Validated Blinding and Unblinding procedures
Third party randomisation center
Genpro can act as a third party randomization centre, which is cited as the most desirable randomization process. Randomization sequences are usually created using PROC PLAN in SAS. As part of validation a dummy randomization list is created. The program and the output are manually reviewed. We also provide blinded/unblinded Statisticians for studies as required. Unblinding is subject to strict procedures and is well documented based on the client specifics.
Offshore Randomisation Center
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Genpro Research Inc.
204 Second Ave, Waltham
MA 02451, United States