Date Submitted: September 30th 2024
Authors: Dalila Nafi/Thierry Escudier
Idea Originators (and Companies) : Jason LaRoche (J&J), Carly Santer (Bayer)
Strategic Priority : Sustainability
Problem Statement
Following the ‘Carbon Footprint of Decentralized Clinical Trials’ project run by Pistoia Alliance members in collaboration with Sustainable Healthcare Coalition members in the industry Low Carbon Clinical Trials (iLCCT) consortium, the first version of the Clinical Trial Carbon Calculator “Eco Design” tool is to be finalized by the end of 2024 and will be accessible to pharma companies and suppliers.
Creating awareness about the tool and providing guidance regarding use of the tool, both for retrospective carbon emission assessment and to support carbon emission reduction through improving R&D planning, is now essential. This will ensure maximum positive impact without delay, aligned with the project objective of reducing carbon emissions from clinical trials.
Idea Proposal and Value Proposition:
A global methodology will be developed to harmonize the carbon emission assessment of pharmaceutical clinical trials, and this will support pharma companies, institutions and suppliers to reduce their carbon emissions with as high level of clarity, alignment, simplicity and urgency as possible.
In most organisations, this assessment will be performed by individuals and teams who do not have sustainability-related expertise (e.g., Clinical Study Managers) therefore they will need assistance and guidance until this becomes standard practice.
The carbon emission assessments of clinical trials will be requested by institutions like the National Health Service (NHS) and might be requested in the future by regulators when approving clinical trials, therefore this new project will positively affect drug development, both in terms of reducing the negative environmental impact of clinical trials and in many areas reducing costs.
Who benefits from solving the problem and how?
- PMs, ClinOps tool users
- All stakeholders of clinical research, including current and future patients, as carbon emission reduction will positively impact climate change and reduce its health-related consequences
What are the quality improvements, or cost / time savings/sustainability-related improvement brought about by this project?
Targeted Outputs
- Globally relevant toolkit to apply the methodology
- Training sessions
- Workshops to accelerate methodology adoption
Example Use Case(s)
For all companies assessing the impact of their clinical trials regarding carbon emissions, a clear, industry aligned methodology is needed.
Critical Success Factors
- Funding commitment from some members
- This can be secured through communicating the benefits of business resilience, risk mitigation and cost effectiveness, to individual organisation and to the entire sector, of early involvement in the project
- Companies engaged with sustainability who are willing to use the tool
- This can be achieved through communicating the benefits (see above) of early adoption of applying the methodology
- Subject matter experts to contribute time and support
- Already available as a result of the ‘Carbon Footprint of Decentralized Clinical Trials’ project
Why This Is a Good Idea / Why Now:
Reducing carbon emissions from clinical trials is the focus of new and upcoming regulations, therefore it is a market access and financially relevant topic; and there is also societal pressure. While pharma companies are struggling to identify where and how to take action to reduce their carbon emissions, due in part to the complexity of clinical trials (global, extensive supply chains, long duration, etc.), industry-wide guidance is needed.
In anticipation of the evolution of future regulatory reporting requirements for clinical trial carbon emissions, there is a need to drive adoption of a harmonized approach to establish a level playing field for all stakeholders; there is an urgency to create this level playing field now, before any company goes too far down their own path, as this will lead to delays in carbon emission reduction and complications in comparing clinical trial carbon emissions across the industry.