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Advancing ESG Standards: Don’t Forget the Community When Decentralizing Clinical Trials!

Photo credit: Austin Chan

As the pharmaceutical industry becomes increasingly aware of the environmental damage that results during the drug development process, decentralizing is unfolding fast and furious. With good intentions, the inclusion of new technologies appears to be a solution but the potential to drive health inequities may not be doing people or the planet justice. Having said that, when companies include life enhancing and life enforcing strategies in organizational operations, innovative possibilities and beneficial outcomes emerge harmoniously for people and the planet, while companies remain profitable.

In relation to life enhancing and life enforcing strategies, companies should primarily focus on two organizational operation goals. If we examine the “assembly line” from the lab bench all the way down the line to clinical trial supply chain and packaging —reexamining waste streams has huge potential. Although technology certainly has a position, high tech has the capability to fool many pharmaceutical professionals. When taking everything into consideration, technology does not necessarily address structural racism or health inequities, or ease the burden on clinical trial participants —or the extractive burden on the earth. [1] Eliminating, or at least reducing, dissonant strategic operations for clinical trial programs has the adeptness to augment companywide environmental, social, and governance (ESG) standards.

If the ESG impact is considered during protocol development, the “devil [is] in the details” may be repurposed, reused, and lastly recycled. In regard to the “E” for clinical trials supplies, affiliates and trial sites have the potential to identify common pitfalls, such as actually increasing ancillary waste and/or carbon emissions. If waste streams are reexamined there are prospects of unforeseen local and global profitability. In addition, depending on the rare earth minerals, which are required for most new “green” technologies, one clinical trial alone may have a negative impact on noticeably more than carbon emissions. The potential to distress resources, like water and land as well as ecosystems and biodiversity is prominently unmistakable without life enforcing and life enhancing strategic plans.

Although an inadvertent reverberation, risks to ESG standards need to be alleviated from the multifaceted aspects of a clinical trial —even entire programs. This includes forging partnerships, not only with various vendors and suppliers, but with the communities where trial activities will take place -this is where the “S” comes in. Establishing purpose for a clinical trial within a community, with the community, is where positive outcomes have immense potential. The thought is that if clinical trials are efficiently designed, waste is automatically reduced and carbon cutting appears in parallel with a presumed patient-centered approach. [2] However, beyond patient-centered is the circumference of community —and it is here where the authentic opportunity resides in creating a dynamic societal shift.

More often than not, there are unjust reasons entire communities are inflicted with disease prevalence. Public health and population health science have cumulatively addressed social, political, economic, and environmental conditions and how the complex interconnectedness contributes to health inequities. [3] In addition, “…some of the most significant impediments to trial participation for some minority subgroups are likely more related to structural racism than mere inconvenience.” [4] Hence, technology not always being the panacea because health inequities “…are the result of the historic and ongoing interplay of inequitable structures, policies, and [systems].” [3] Life enforcing and life enhancing clinical trial strategic operations have the capability to improve community conditions and health-related outcomes for the wellbeing and betterment of all people. When the circumference of community is enrolled, clinical trial milestones are surpassed and the full potential of ESG is actually realized.

Consequently, why not reexamine the magnitude of change the pharmaceutical industry may contribute to environmental and social justice through clinical trial operations? Patient-centered trials transition into community-centered healthcare solutions by way of powerful partnerships of influence. Considering decentralizing clinical trials? Don’t forget the communities —as when life enhancing and life enforcing strategies are included in clinical trial operations all living entities (people and planet) have the possibility to thrive —and it’s not all bad for profit either! So how should this be done? Engage in conversation and develop relationships with the communities —as communities, who have been disadvantaged by systems, are eagerly waiting!


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