Through the Clinical Trials Environmental Impact Community of Interest, the not-for-profit alliance will bring together pharma companies, CROs, and academic representatives to generate insights into the effects of different clinical trial models on the environment.
The CRO Syneos Health started the initiative, which has now grown to include 25 members, including top 10 pharma companies, based in Europe, Japan, and the US. GSK, Johnson & Johnson, Merck and Novartis are among the supporters of the community.
Bert Hartog, senior director of clinical innovation at J&J’s Janssen, explained his company’s interest in the initiative in a Pistoia Alliance statement to disclose the creation of the environmental impact community.
“Shared frameworks have to be created to allow individuals and companies to be efficient and effective in quantifying the impact of their own clinical trials against an industry-wide standard,” said Hartog. “At Janssen, we are always looking for ways to reduce our impact on the environment whilst continuing to innovate and produce life-changing therapies.”
The collaborative project, which Hartog sees as the “best way to make lasting change happen,” will break the challenge of measuring the environmental impact of clinical trials up into two phases.
In the first phase, the collaborators are working to agree on the parameters and variables that will be measured. Once that is done, the initiative will advance to the second phase, in which the focus will shift to the creation of a methodology for calculating the carbon footprint of site-based and decentralized trial models. The alliance will make the methodology available publicly to serve as a cross-industry standard.
Decentralized clinical trials reduce, and in some cases, eliminate patient travel to and from sites, and thereby also reduce the carbon emissions associated with that travel. The initiative could provide a framework for quantifying the impact of reduced travel and of the many other variables that determine the carbon footprint of studies.
Recognizing that diverse skills and knowledge will be needed to develop the framework, the alliance is seeking experts in sustainability, clinical development, and other relevant fields to join the project.