By Donna Libretti Cooke, clinical operations independent specialized consultant
While ESG (environmental, social, and governance) may be the outed, “dirty” term1 in corporate meeting rooms, the drive for corporate responsibility remains. And the life sciences industry is no different as it recognizes the need for more sustainable approaches to the drug development process. Industry conferences now have environmental sustainability topics, providing guidance for new carbon emission calculation tools for clinical trials and technological innovations for reducing clinical supply waste.
These areas may seem daunting to tackle. But fortunately, the industry’s pre-competitive collaboration efforts are alive and well and pivotal for launching such sustainability endeavors. A working example of incredible cross-collaboration and partnerships gaining traction over the past few years is the quite simple “low hanging fruit” approach: donating unused clinical trial supplies for humanitarian aid and to support STEM educational training programs. One platform supporting such donations is Kits4Life3, which is run by Med Surplus Alliance (a program within The Task Force for Global Health).
ClinOps professionals know all too well the waste that occurs with leftover trial kits that are destroyed at the end of the trial. Like boxes piled high in limited storage space, which can take on average four hours to destroy. Thankfully, this wasteful activity that burdens clinical trial sites is becoming outdated, with a fundamental shift to placing these viable supplies into needy health communities and for STEM educational programming. Using a secure platform, Kits4Life enables partner sponsors to donate unused trial supplies from their sites and from warehouses or offices within their organization. It’s a win-win for sites, sponsors, clinical trial service providers, and, most importantly, for those in need.
With additional sponsor partners joining Kits4Life, newly identified ancillary supplies and equipment donations have been identified, opening up previously untapped resources of surplus clinical trial supplies for donations. Examples include, but are not limited to, lab analyzers, thermometers, blood glucose monitors, infusion pumps, smartphones/tablets, lancing devices, pregnancy kits, syringes, and even recruitment and retention items.
Sponsors contribute, not including pharmaceuticals, supplies, devices, and equipment. These items typically fall into two categories: high-volume, low-value donations and low-volume, high-value donations. High-volume, low-value donations include items such as study kits, needles, masks, gloves, lancing devices, and other assorted medical items. Their donations typically run in the dozens, hundreds, or thousands. Conversely, low-volume, high-value donations usually come in numbers of 50 or less and include things such as technology tools (phones, tablets, etc.), swab kits, specimen containers, pregnancy kits, and lab coats, to name a few. From February 2023 to November 2023 alone, sponsors contributed to the following growth in the Kits4Life program:
- almost a 37% increase in high-volume donations
- almost a 25% increase in low-volume, high-value donations
Both original pharma partners and eight new pharma partners and CROs contributed to the program, bringing total partners to 14 as of January 2024.4 Expansion efforts outside the U.S. are also in place, with Australia being the first OUS country to have a nonprofit become accredited and come under the Kits4Life umbrella.
This momentum for donating supplies through Kits4Life has occurred due to:
- unique, collaborative partnerships, such as those with MedSurplus Alliance, sponsors, CROs, lab partners and the medical surplus recovery organizations (MSROs)
- accreditation of MSROs, which accept donations and process them per the MedSurplus Alliance Code of Conduct, World Health Organization guidelines and International laws
- a standards-based platform rooted in the MedSurplus Alliance Code of Conduct Standards
- quality assurance and effective distribution that meets partners’ expressed needs and avoids waste
- easy-to-use on-boarding toolkit for sponsors
An automated donation platform allows sponsors to monitor donation deliveries in real time and allows for quick reporting. Additionally, MedSurplus Alliance gathers impact stories from MSROs to illustrate the tangible and meaningful health impact of such donations. A few examples include:
- Donated lab analyzers reached community health centers in Kenya and Tanzania
- Over a dozen ECG machines reached Ukraine
- Specialized ophthalmology equipment to Ghana
- Smartphones and tablets support a children’s digital literacy program in the U.S.
For the first time, ClinOps professionals can integrate a sustainability effort into their business processes.
Political will is defined as “the commitment of actors to undertake actions to achieve a set of objectives… and to sustain the costs of those actions over time.”5 In working with several pharma partners over the past few years and seeing new ones come on board, it’s clear there is sufficient political will for this worthy cause. In implementing this program first-hand, participating in the advisory council, and chairing the on-boarding workstream, I envisioned a goal in which donating surplus clinical trial supplies and equipment becomes a global standard in our industry.
The best experiences of seeing this political will in action? Witnessing the remarkable collaboration among several stakeholders and the demonstrable results that are truly making a positive impact on global health.
This endeavor is at a critical stage now, as new pharma partners can help drive this commitment to grow and sustain the effort. The MSROs need to increase their capacity to accept the supplies and responsibly place them in healthcare communities. Meanwhile, clinical trial sites are eager to participate via their sponsors’ trials. Imagine tapping into this low hanging fruit of these supplies, avoiding their rotting away and, instead, assessing their viability, steering them toward this secure, quality donation platform and know you are part of the solution in closing the healthcare gap.
- The Latest Dirty Word in Corporate America: ESG - WSJ
- Clinical Supply at SCOPE Summit – Workshop on ‘Reducing the Environmental Impact of Global Clinical Trials’; Sessions on ‘Enhanced Drug Forecasting to Minimize Waste and Right-Size Supply Inventories with Lens for Environmental Sustainability’; ‘Reducing Clinical Supply Waste through Modeling and Integrations’
- Bayer Wins U.S. Chamber of Commerce Foundation’s Annual Citizens Award | Business Wire; Bayer’s Supply Donation Program Wins Top Spot in WCG’s First Innovation Challenge | 2022-10-21 | CenterWatch
- See Kits4Life | MedSurplus Alliance website for list of current Partners.
- Political Will: What It Is, Why It Matters for Extractives and How on Earth Do You Find It? | Columbia Center on Sustainable Investment
About The Author:
Donna Libretti Cooke, JD, is the former director of global contracts & budgets at Bayer and successfully implemented the Kits4Life program within Bayer’s clinical operations organization — the first organization to roll out Kits4Life for its clinical trial sites — and has won two industry awards for these efforts. Donna is now a clinical operations independent specialized consultant providing services to drive clinical operations’ sustainability efforts, participant payment strategies for patient engagement and diversity efforts, and site sustainability.
Kits4Life’s Greg Folz and Lori Warrens contributed to this article. Greg is the founder of Kits4Life and won the SCRS Site Tank Award in 2016, enabling matching the idea with MedSurplus Alliance. Lori Warrens is the program director for MedSurplus Alliance, which engages and inspires cross-sector medical product donation partners to advance equitable access to health by providing quality medical products when and where they are needed. The Alliance is a program within The Task Force for Global Health, a 501(c)3 non-governmental organization, which provides all people with opportunities to lead healthy, productive lives.