EARLY-STAGE CLINICAL DEVELOPMENT


Scenario planning as a risk-management tool


Brad Miller, clinical operations director at Biosceptre, a company developing antibody and CAR-T therapeutics against nfP2X7, discusses the challenges of scenario planning in clinical trials.


in the development of their early-stage clinical development programme. However, with descriptions like rules-based and model-based designs being thrown around, the early-stage researcher with limited clinical experience may not have sufficient understanding of an accelerated titration or traditional 3+3 design, or what is meant by a continual reassessment method (CRM) or Bayesian model to undertake


S


mall and emerging biotechs often engage consultants and clinical research organisations (CROs) to assist and advise


appropriate scenario planning and risk mitigation. While it is common to rely on the expertise and experience of the consultant or CRO in identifying the most appropriate study design for the therapeutic under investigation, the small and emerging biotech must be aware of the implications to the time and expense of the proposed study design. Ideally, they should explore a number of ‘what if?’ analysis and scenario plans to understand the implications to not only their clinical development, but also their corporate goals.


82 | Outsourcing in Clinical Trials Handbook


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