Pistoia Alliance Launches Global Community of Interest to Assess the Environmental Impact of Clinical Trials

The Pistoia Alliance recently announced the launch of the Clinical Trials Environmental Impact Community of Interest (CoI) to measure and compare the carbon footprint of centralized (traditional site-based) and decentralized clinical trials. The initiative was started by Pistoia Alliance member, Syneos Health, which submitted it to the Alliance for further development. The new CoI also work closely with member organization, the Sustainable Health Coalition (SHC) in support of its work with the Sustainable Markets Initiative (SMI). The Pistoia Alliance and the SHC will further align with the SMI as its efforts in this space develop.

In phase one, the Community of Interest is working to collectively agree the parameters and variables that will be measured. The second phase will see it develop a methodology for calculating the carbon footprint of both trial models. This methodology will be published as a publicly available tool to deliver a cross-industry standard for quantifying the carbon impact of a trial. The CoI currently has 25 members spanning Japan, US, and Europe, including top 10 pharma companies, CROs, academic representatives.

“Syneos Health is committed to delivering on our environmental goals and finding ways to make clinical development activities more sustainable,” said Noolie Gregory, Vice President, Decentralized Solutions for Syneos Health. “The Pistoia Alliance offers us a unique, collaborative space to make this happen. Through this initiative, we can drive toward a tangible outcome that will make a material improvement in how we assess the carbon impact of trials and make recommendations for the reduction of this footprint. We are looking forward to working with our peers and colleagues to share our knowledge.”

There is growing pressure from patients, governments, healthcare payers and providers to reduce the environmental impact of the life sciences. In the future, it can be expected there will be legislation that will necessitate pharma and research companies adjust their behaviors and develop new ways to measure and report on the environmental impact of their operations. To prepare for this change, the Alliance believes that companies working together on assessing the impact of trials is a key starting point. Clinical trials are complex and have many moving parts – typically spanning multiple geographies, jurisdictions, and hundreds of different sites. To create a robust and accurate methodology that benefits the industry will require a broad mix of experts and opinions from both the life sciences and sustainability fields.

“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,” commented Dr Bert Hartog, Senior Director of Clinical Innovation at Janssen. “At Janssen, we are always looking for ways to reduce our impact on the environment whilst continuing to innovate and produce life-changing therapies. We are very keen to get involved in collaborative projects such as the new Pistoia Alliance COI because we recognize that they are the best way to make lasting change happen in our industry.”

“Decentralized trials reduce the burden on the patient and ensure trials are far more patient centric. Whilst quantifying money and time saved is relatively straightforward, accurately measuring the carbon saving requires a more detailed approach to produce a standard that can be used by all stakeholders – from sponsors to CROs to technology vendors,” commented Thierry Escudier, Strategic Leader for Empowering the Patient at Pistoia Alliance. “There’s lots of great work being done in the industry, and the Alliance hopes to work alongside these other groups. The scale and complexity of the issue makes it perfectly placed for the Alliance to tackle – it’s multidisciplinary, global, and industry-wide. We are now calling for all those interested – including research organizations, investigators, pharma companies, and patient groups – to get involved.”

The Pistoia Alliance is seeking experts in sustainability, clinical development, and other relevant fields to join the Community of Interest. Individuals and organizations interested in the initiative should email Thierry Escudier at ProjectInquiries@PistoiaAlliance.org. For more information on the Pistoia Alliance, visit https://www.pistoiaalliance.org/.

The Pistoia Alliance is a global, not-for-profit members’ organization made up of life science companies, technology and service providers, publishers, and academic groups working to lower barriers to innovation in life science and healthcare R&D. It was conceived in 2007 and incorporated in 2009 by representatives of AstraZeneca, GSK, Novartis, and Pfizer who met at a conference in Pistoia, Italy. Its projects transform R&D through pre-competitive collaboration. It overcomes common R&D obstacles by identifying the root causes, developing standards and best practices, sharing pre-competitive data and knowledge, and implementing technology pilots. There are currently over 200 member companies; members collaborate on projects that generate significant value for the worldwide life sciences R&D community, using The Pistoia Alliance’s proven framework for open innovation.