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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).

  • 3+3 Design

  • 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

  • Statistical Support

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

 

Microbiome Analysis

Genpro Research can perform microbiome analysis. Our biostatistics team will identify the statistical analyses needed to reach the objective. In one of the recent animal trials that our team worked included Kaplan Meir analysis to compare the effect of treatment group. All analyses are performed and validated using SAS.

Some analysis we have done are below.

  • Mean summary.

  • Kaplan Meir summary

  • Summary Graphs

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MMRM ANALYSIS

Genpro Research can perform different analysis based on the requirement. In one of the recent phase 2 study we had to perform MMRM analysis to compare the mean change from baseline between treatment groups. An unstructured covariance (UN) matrix will be used to model the within subject errors. The Kenward-Roger (KR) approximation used to estimate denominator degrees of freedom. If the model for unstructured covariance matrix fails to converge, the heterogeneous Toeplitz covariance structure, followed by heterogeneous auto regressive covariance structure, used. The assumptions of the model, including normality, will be evaluated using residual and other diagnostic plots of model fit. The null hypothesis is that the mean difference between the dose groups and placebo is zero, versus the alternative hypothesis that this difference is not zero.

All analyses are performed and validated using SAS.

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Case Study

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Contact Us

We are eager to hear from you!

Genpro Research Inc.

204 Second Ave, Waltham

MA 02451, United States

+1.781.790.5524

info@genproresearch.com

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