MIC offers consultation on clinical research activities that range from designing the study design and methodology setup to data collection and analysis. MIC offers custom support to clients on the following aspects and holds one-on-one discussions with them after gaining an understanding of their project requirements.
Conceive Study designs for Phase I to Phase IV studies
Conventional 3+3 dose escalation Vs Continual Reassessment Method Vs accelerated dose titration, or Bayesian study design for Phase I studies.
Single agent open-label proof of concept study Vs randomized double-blind, active/placebo control study in Phase II study.
Randomized, double-blind, active/placebo control study with/without the single agent dose extension in Phase III study.
Selection of the Primary and Secondary Endpoints
Overall Response Rate (ORR) plus Duration of Response (DOR)
Progression-free Survival (PFS) Vs Overall Response Rate (ORR)
Progression-free Survival (PFS) Vs Overall Survival (OS)
Overall Response Rate (ORR) Vs Clinical Benefit Rate (CBR)
Pharmacodynamic markers
PK assessments (e.g. Cmax and AUC)
Dose Limiting Toxicities and Maximum Tolerated Dose
Selection of the Exploratory Biomarkers
Selection of Cytokines/Chemokines (e.g., IL-2, IL-4, IL-10, TNF-α)
Baseline mutational status (BRAC1/2, NTRK, ATM)
Pharmacodynamic markers
Provides inputs to Statistical Analysis Plan (SAP)
Provides inputs to Tables, Listings, and Figures (TLFs)
Provides inputs to Ad-hoc and exploratory statistical analyses.
Determination of the Effect Size for Sample size calculation.
Determination of the “Go/No Go” criteria for drug development.
