Author byline as per print journal: Sandeep N Athalye, MBBS, MD; Shylashree Baraskar; Shivani Mittra, MPharm, PhD; Elena Wolff-Holz, MD

Abstract:
Clinical drug development is among the highest producers of greenhouse gas (GHG) emissions, with about 4.4-4.6% of the worldwide GHG emissions coming from the pharma sector. Thousands of clinical trials are carried out yearly, and they directly affect planetary health through GHG emissions. In a world where environmental stewardship, socialdiversity, and equitable governance (ESG) are progressively becoming biomarkers of business purpose, adopting practices that demonstrate the same within the clinical trials stakeholder network is imperative. Innovation in clinical trials that delivers affordable access to life-saving therapeutics for patients worldwide is fast becoming the core of the ESG strategy. The way clinical trials are conducted has a significant impact on the environment and planetary health. The pharma companies are encouraged to take the climate pledge to reach net-zero carbon emissions by 2040. Hence, ESG strategies need to be closely aligned with the clinical development requirements, targeting efficient clinical operations and creating equitable, sustainable, and viable health for all. Leaner and more efficient clinical trial designs are the need of the hour. There is also an urgent requirement to develop tools capable of measuring the carbon footprint of clinical trials.  This article discusses/reviews how clinical researchers can align with the ESG goals for the efficient conduct of clinical trials of biologics and biosimilars.

Submitted: 17 April 2024; Revised: 15 July 2024; Accepted: July 2024; Published online first: July 2024

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.