IDDI, Biostatistical and eClinical Services for Clinical Trials

TRIAL DESIGN - RANDOMIZATION - DATA MANAGEMENT - BIOSTATISTICS
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Trial design

The study design of a clinical trial is the catalyst for success:

IDDI is unsurpassed in developing the statistical section of clinical trial protocols.

Its experts will help prepare this crucial document, defending it with the regulatory authorities (e.g. FDA or EMA).

30% of trial failures are due to poor design ..."many say that a significant number of good drugs are being lost to outdated and impractical clinical-trial designs" (Source: Article by Heidi Ledford in Nature p.526 Vol 477 - 29 September 2011).

 

IDDI Consultants 

  • 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. Agnes Westelinck (Regulatory Affairs)

...will help you find the optimal design for your specific program: 

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
Biosimilars - non inferiority
 

IDDI's experience includes:

  • Patient selection (wide versus restricted population)
  • Control of heterogeneity (stratification)
  • Treatment allocation methods (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)