Basket & Umbrella Trials

New clinical trials’ designs in the cancer genomic era

Precision Medicine, a growing trend based on the genotype of the individual, allows for the development of precise and valid diagnostics. The success of this healthcare approach depends on the recognition of predictive biomarkers that help researchers identify patient sub-groups that may be more receptive to treatment.

With biomarkers, it is possible to provide the right treatment to the right patient, at the right dose at the right time.

Biomarkers are being used in early clinical trials in order to direct targeted agents to those patients considered to become more broadly receptive, and new clinical trials’ designs are emerging – Basket or Bucket Trials and Umbrella Trials.

 

Medicine is moving towards a tailored path, especially for oncology and rare diseases. Eurotrials is aware of that and gathered all its expertise to offer you a solution that improves clinical research efficiency:

 

  • Definition of strategic plan and targeted subgroups
  • Design or revision of Master protocols
  • Variables definition for data collection tools (case report forms, patients reported-outcomes and surveys)
  • Writing of informed consent forms and other documentation addressed to the patient
  • Development of clinical study database
  • Development of the statistical analysis plan
  • Statistical analysis (descriptive statistics and endpoints analyses, including interim exploratory and post-hoc analysis) using SAS® or IBM SPSS -PSE
  • Randomization procedures (adaptive)
  • Sample size calculation (powered for subgroups)
  • Site selection & feasibility
  • Site qualification (on-site or remote)
  • Regulatory submission
  • Contracts negotiation
  • Site Initiation
  • Monitoring
  • Close-out
  • In-house monitoring (via Electronic Data Capture/WebPortals)
  • Site management-encouraging, support and training the investigational team
  • Managing study supplies
  • Clinical site payments

 

  • Multinational team management
  • Multilanguage project managers
  • Vendors management
  • Project management plan
  • Communication plan
  • Training of study teams
  • Projects metrics
  • Contingency plans & risk management
  • Budget tracking