The design of a study is the masterpiece of a study. Optimal study design is key to the success of the trial. IDDI Consultants provide this expertise under a Consultancy mode.
This group of experts incudes :
- Dr. Marc Buyse (biostatistics and oncology)
- Prof. Tomasz Burzykowski (surrogate endpoints, adaptive and bayesian designs)
- Dr. Stefan Michiels ( designs including biomarkers)
- Dr Everardo Saad, Medical Advisor Oncology
- Dr. William Blackwelder (biostatistics and infectious diseases)
FDA/EMA experts will be reviewing Sponsor's study protocol. IDDI is fully experienced in developing the statistical section of clinical trial protocols, and its experts will help prepare this most important document, defending it with the authorities.
We can assist you with the proper design:
- Phase I - classical modified Fibonacci, continual reassessment (e.g. in cancer trials)
- Phase II - randomized, stratified, multinomial, two-endpoint, three-outcome, multi-stage, dose-finding
- Phase III - cross-over, sequential, group-sequential, adaptive designs, seamless phase II/III
- Phase IV - large, simple trials
- Biomarker designs
Including:
- Patient selection (wide versus restricted population)
- Control of heterogeneity (stratification)
- Treatment allocation method (minimization, permuted blocks, etc.)
- Endpoints of interest (including use of surrogate markers)
- Scales to measure and standardize treatment benefits or harm
- Sample size calculation
- Duration and intensity of follow-up
- Factorial designs
- Methods of analysis (including interim analyses)
IDDI's experience is unsurpassed in these areas.