2.3 - Investigational Product (IP)
Calculations
Investigational product calculations (manufacture + supply + end of life) The results for this section are a sum of the manufacture, supply and end of life impact of investigational product(s) used.
Manufacture
Input based on total number
If based on a total number:
Number procured per trial x drug emission factor
Example in which 10,000 tablets are procured:
10000 x 0.200 = 2,000 kg CO 2 eq
Input based on total spend
If based on total spend:
Total spend per trial x drug spend emission factor
Example in which $150,000 is spent on drugs:
150000 x 0.032 = 4,800 kg CO 2 eq
Input based on number per participant
If based on number per participant:
((Number per participant + (number per participant x overage))
x drug emission factor) x number of participants
Example in which 50 tablets are procured per participant, with 50% overage and 100 participants in total:
((50 + (50 x 50%)) x 0.200) x 100 = 1,500 kg CO 2 eq
Note: A manual override of the kg CO 2 eq per unit (tablet, vial etc.) is allowed for, a user specified emission factor can be entered to calculate the impact of manufacture. This manual override should be used with caution, we recommend only a 3 rd party assured cradle-to-gate emission factor is used. This function cannot be used when spend is selected.
Note: A placebo factor has also been included for IP manufacture impacts, if this option is ticked it is assumed the IP in question contains no active pharmaceutical ingredient and the impacts are reduced by 65%. Only the manufacture impact is reduced, and this function can’t be used when spend is selected.
Supply
If ‘local’:
No transport impact
If ‘central’:
- If ‘total number’:
(Number of kits procured per trial x kit weight x distance from US capital to UK capital
x air freight emission factor) +
(number kits procured per trial x kit weight x default road distance x road freight emission factor)
Example in which 10,000 kits are supplied from US to UK:
(10000 x 0.5kg x 6000km x 0.00123 kgkm) + (10000 x 0.5kg x 1000km x 0.00012 kgkm) = 37,500 kg CO2 eq
Note: For multiple countries it will be necessary to determine the proportion of total participants associated with each country and this proportion applied to the total number of kits etc.
- If ‘total spend’:
Impact of supply is included in the manufacture calculations.
- If ‘number per participant’:
(Number of kits per participant including overage x number of participants in trial country x kit weight
x distance from US capital to UK capital x air freight emission factor)
+ (number of kits per participant including overage x participants in trial country x kit weight
x default road distance x road freight emission factor)
Example in which 10 kits per participant are supplied from US to UK with 50% overage and 20 participants in UK:
(((10 + (10 x 50%)) x 20 x 0.5kg x 6000km x 0.00123 kgkm)
+ (((10 + (10 x 50%)) x 20 x 0.5kg x 1000km x 0.00012 kgkm)
= 1,125.00 kg CO2 eq
Note: this would need to be calculated for each country that is supplied kits. In this example, it is assumed just the UK.
End of Life
If ‘local’:
- If ‘total number’ (for example based on total number of tablets and vials):
(Number of tablets/vials x end of life emission factor)
Example in which 10,000 tablets are procured:
10000 x 0.01 = 100 kg CO2 eq
- If ‘total spend’, disposal cost needs to be estimated:
((Total drug spend x percentage estimate of waste disposal cost) x end of life emission factor)
Example in which $150,000 is spent on drugs, assuming the cost of waste disposal is equivalent to 10% of the total spend:
(150000 x 10%) x 0.137 = 2,055 kg CO2 eq
If ‘number per participant’:
((Number of tablets/vials per participant including overage x end of life emission factor)
x number of participants)
Example in which 50 tablets are procured per participant with 50% overage and 100 participants in total:
((50 + (50 x 50%) x 0.01)) x 100 = 75 kg CO2 eq