Pistoia Alliance To Explore Clinical Trial Ecology Influence

The Clinical Trials Environmental Impact Community of Interest (CoI) has been launched by The Pistoia Alliance, a global, non-profit alliance that promotes increased collaboration in life sciences R&D. Its goal is to calculate and compare the carbon footprints of centralised (traditional site-based) and decentralised clinical trials. Syneos Health, a member of the Pistoia Alliance, initiated the project and presented it to the Coalition for future development. In support of its engagement with the Sustainable Markets Initiative, the new CoI also collaborates closely with another member organisation, the Sustainable Health Coalition (SHC) (SMI). As the SMI’s projects in this area move forward, the Pistoia Alliance and the SHC will work together with it more and more.

The Community of Interest is attempting to reach consensus on the parameters that will be monitored during phase one. It will create a mechanism for figuring out the carbon emissions of both experimental models in the second phase. This approach will be made public in order to provide an industry-wide standard for calculating the carbon effect of a trial. Including representatives from the top 10 pharmaceutical companies, CROs, and academic institutions, the CoI now has 25 members from Japan, the US, and Europe.

Noolie Gregory, Vice President, Decentralized Solutions at Syneos Health, stated that Syneos Health is committed to achieving their environmental goals and discovering ways to make clinical development processes more sustainable. To do this, the Pistoia Alliance provides us with a special environment for collaboration. Through this endeavour, they may work toward a concrete result that will significantly improve how they evaluate the carbon footprint of trials and offer suggestions for lowering it. They look forward to working with their peers and colleagues to share this knowledge.

The environmental impact of the life sciences is coming under increasing scrutiny from individuals, governments, healthcare payers, and providers. Future regulation is likely to require pharma and research businesses to modify their practises and create new methods of calculating and disclosing the impact they have on the environment. The Alliance thinks that companies collaborating to evaluate the effects of trials is a crucial first step in getting ready for this transition. Clinical trials are intricate processes with numerous moving pieces that can span many different jurisdictions, regions, and venues. A diverse range of specialists and viewpoints from both the biological sciences and sustainability disciplines will be needed to develop a sound and accurate technique that is beneficial to the industry.

Dr. Bert Hartog, Senior Director of Clinical Innovation at Janssen, stated that shared frameworks must be developed to enable people and businesses to effectively and efficiently evaluate the outcomes of their individual clinical trials against an industry-wide standard. At Janssen, they continuously seek ways to lessen our environmental footprint while striving to develop and produce therapies that can change people’s lives. They are eager to participate in cooperative initiatives like the new Pistoia Alliance COI since they understand that it is the most effective approach to bring about long-lasting change in the sector.

Decentralized trials ensure that studies are far more patient-centric and lessen the strain on the patients. According to Thierry Escudier, Strategic Leader for Empowering the Patient at Pistoia Alliance, while measuring cost and time savings is fairly straightforward, measuring carbon savings requires a more thorough approach in order to produce a benchmark that can be used by all stakeholders, from sponsors to CROs to technology vendors. The Alliance wishes to collaborate with such other organisations because there is a lot of excellent work being done in the sector. The issue is multidisciplinary, worldwide, and industry-wide, making it ideal for the Alliance to address due to its size and complexity. They are currently requesting participation from anyone who is interested, including research organisations, investigators, pharmaceutical firms, and patient groups.