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Innovative Trial Design and Diagnosis

Innovative Trial Design and Diagnosis

According to a recently published paper, the failure rate of Phase II to Phase III is about 70%. Many clinical trials still use the traditional fixed design where no interim analysis is performed, and the results turn out to be either short of positive or totally negative. There might be multiple reasons to blame for the high failure rate, including ineffectiveness of the experimental treatment itself, safety, and commercial viability, etc. But, if we think about it more deeply, by anatomizing the conventional clinical trials, we realize that there are some deficiencies or limitations of traditional study design and conduct that may be associated to the failure in clinical trials. In September 2018, the US FDA issued a new Draft Guidance: Adaptive Designs for Clinical Trials of Drugs and Biologics, replacing the previously published 2010 draft. This guidance clearly reflects the FDA’s view on developing and implementing innovative trial design for future clinical trials.

Brightech’s trial design experts are comprised of internationally recognized frontiers in Group Sequential Design (GSD) and Adaptive Design (AD) with numerous publications that are considered as guiding research adapted by industry, academia, and FDA.

Services include:

  • Innovative trial design (GSD, AD, Phase II/III seamless, etc.)
  • Design and strategy for natural history studies in rare diseases
  • Design and data analysis of RWE studies
  • Trial diagnosis on completed studies, especially for failed studies.
  • Interim analysis planning, execution and interpretation
  • Sample size re-estimation
  • High-level statistical and strategic consulting