The design of a study is the masterpiece of a study. Optimal study design is key to the success of the trial.
Often, controlled clinical trials are preceded by epidemiologic studies that provide better insight into the disease of interest, its prevalence, its demographic and etiological factors. We help design such studies (case-control, cohort studies, etc.) or analyse the results of these studies (including through a formal meta-analysis of their results).
IDDI is not involved in pre-clinical research.
Design Optimal Clinical Trials with a group of experts led by the following individuals:
- Dr. Marc Buyse (biostatistics and oncology)
- Prof. Geert Molenberghs (statistical modelling)
- Prof. Tomasz Burzykowski (surrogate endpoints)
- Dr. William Blackwelder (biostatistics and infectious diseases)
Protocol Development
The Protocol describes the objective(s), design, methodology, statistical considerations, medical background and organization of a clinical trial. Study design is an essential part of the protocol. Without a good design, the most carefully performed study can fail.
FDA/EMEA experts will be reviewing your study protocol, IDDI experts will help you prepare this most important document and defend it with the authorities.
IDDI is fully experienced in developing the statistical section of clinical trial protocols, as well as Investigators' brochures and all related trial documents.
IDDI is very experienced in trial designs
- 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/II
- Phase IV - large, simple trials
- Biomarker designs
We can assist you with the proper design, 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.