How to submit an asset for assessment and prioritisation for inclusion in Glo-BNHL?

Information regarding a potential asset for consideration for inclusion in the trial should be submitted electronically to the trial mailbox:

This documentation should include a completed summary sheet (downloadable below) and additional detailed information (in any suitable format) covering the following information:

Primary target

Mechanism-of-action and scientific rationale for the target

Pre-clinical data

  • Details of cell lines and models used
  • Concentration range tested and relation to human dosing
  • Observed responses and validation

Clinical data

  • Safety data in adults including severity and frequency of Adverse Events, ability to support/modify toxicity and details of population in whom tested
  • Efficacy data in adults including details of tumour types, population, dosing regimens, study design and end-points
  • Any early safety/efficacy data in paediatrics if available (any disease)

Feasibility in paediatrics

  • Plans for development of paediatric formulation (if applicable)
  • Pharmacokinetic studies or modelling supporting starting dose decision in children (if available)

Members of the TSC will review the information pack. A decision regarding inclusion in the trial will be reached during offline review of the documentation and a TSC videoconference. Every reasonable effort will be made for all TSC members to be present however the minimum attendees required for the TSC to be quorate for decision-making has been defined in the approved CRCTU Charter as “at least seven members, including a statistician, one trial management group member and three clinicians (including the Chair, unless otherwise agreed)”. Additionally a videoconference will be offered between the relevant industry partner and the Sponsor/Chief Investigator to allow for questions and clarifications prior to a final decision being reached.

The TSC have committed to returning the final decision regarding inclusion of the asset in the Glo-BNHL trial within four weeks of receipt of the information pack. The decision will be returned in writing alongside a detailed summary of the rationale to facilitate subsequent interaction with the relevant regulatory bodies.