Document GbaojVdX0k6y5Lvpm734qGLq

24 May 2005 Concawe review of petroleum industry workers studies benzene/leukaemia Phase 2 Scoping Considerations Motivation for pooling 3 studies (IOL, IF, HW) 1. Present new data to inform the regulatory debate (on the benzene OEL) 2. Increase power: to examine leukaemia/diseases other than AML (at current/recent benzene exposure levels in the global petroleum industry) to examine exposure-response function for AML, including identification of NOEL o and if possible the most appropriate exposure metric 3. Operate efficiently: Report results in time (i.e. < 2 years project) Contain project costs Options for pooling according to 10M report: 10M suggestion (essential or optional) How? By whom? Estimated cost Increase the number of case-sets in the database (optional)1 Using the extended follow-up now available particularly for the IP and IOL studies 2 Original study PI's 500 k Validate the exposure k-factors, and rationalize these across studies (essential) Using all existing measurement data on airborne benzene concentrations, rework parts of the exposure assessment and assigmnent Expert panel with knowledge of the industry and studies, i.e. hygienists originally involved [but this time guided by academic, e.g. 10M or IRAS?] 250 k Rationalise distinction between leukaemia cell types across studies (essential) Re-visit all case diagnoses centrally 3 Small panel of haematology 150 k experts Analyse pooled data with modern statistical methods (optional) Avoid arbitrary grouping strategies Original PI's [supplemented 50 k with 10M?] Sensitivity analysis of Using exposure estimate Original PI's [supplemented 50 k 1 Considerations of study power should be brought to bear on this, but also time required for follow-up (3-4 years?) 2 10M suggests that because HW was finished only recently, very few additional cases have emerged- however, it may be more fair if all 3 studies were treated equally, irrespectively of size 3 Writer has no concept of the nature of this work- and is it feasible, considering institutional etc. constraints? CGU BEN0000054 exposure-response modelling (optional) variability information with 10M?] CGU BEN0000055