Building Clinical Trial Infrastructure for Greater Diversity

Contributed Commentary by Tim Root, Marketing Director of Stirling Ultracold, part of BioLife Solutions

April 8, 2022 | The life sciences industry has faced recent criticism for its continued challenge to boost diversity in clinical trials. Reports suggest that the US Food and Drug Administration (FDA) is currently at work on guidance that will define how the agency would interpret “adequate representation” of ethnic, racial and age diversity to increase representation of traditionally underrepresented populations in drug development. This will ensure organizations are broadening eligibility criteria through inclusive trial practices and trial design.

While diverse clinical trials can offer a wide range of benefits to marginalized groups, inherent obstacles, such as inability to travel to clinical sites, have stood in the way of true improvements. Fortunately, decentralized clinical trials (DCTs) are becoming essential to reach more diverse patient populations and keep them enrolled throughout the trial. Considering that many of today’s advanced investigation medicines are increasingly temperature sensitive, “pop up” ultra-low temperature (ULT) freezer deployments will be essential for storage of treatments in these decentralized and hybrid models. This article will discuss how organizations and researchers can help address some of the most prevalent challenges that have historically hampered trial diversity.

Understand the Obstacles Marginalized Communities are Facing

By broadening representation in medical research, scientists can determine which treatments are safe and effective, while also understanding the risks of various medications across diverse populations. Different people can have varying reactions to the same medication, based on their race, age, sex, geographic location and more. A different dose or drug may be required to help treat the same illness or disease—a factor that can only be determined through comprehensive medical research of diverse participant demographics.

At the same time, there are a multitude of obstacles that could preclude a qualifying patient from joining a clinical trial. Over 70% of Americans live more than two hours away from a clinical research site, which can create considerable logistical challenges for those who don’t have access to reliable transportation infrastructure. Not to mention, this can cause much financial burden on participants, with 64% of patients in early-phase oncology trials last year disclosing that they had unanticipated, out-of-pocket nonmedical costs involved with lodging, meals, parking and fuel. Fortunately, DCTs could solve for many of these pain points.

Adopt a Decentralized Model

DCTs can mitigate many barriers that are intrinsic to on-site clinical trials, as they can accelerate patient recruitment rates, while reducing dropout rates among marginalized populations. Rather than having the patient travel to the clinical trial site, this approach is more patient-centric, as trials are primarily virtual or accessible at satellite locations near participants’ homes. Although this may not automatically result in increased engagement among diverse groups, these models have already seen profound results. Organizations that have used a decentralized system have achieved more than 90% patient retention rates and three-times faster patient enrollment. However, bringing DCTs to marginalized populations will require more decentralized and portable infrastructure.

Implement Reliable, Flexible Infrastructure

Precision medicine treatments, such as cell and gene therapies, are advancing at a rapid pace and have become more sensitive to temperature fluctuations. As a result, precision medicine researchers must consider temperature changes much more closely. These medications must be stored at ultracold temperatures (-20°C to -80°C) to maintain drug stability and remain effective. Many organizations and researchers have relied on large compressor-based freezers that require special infrastructure that is impractical to support in remote, decentralized settings or have used dry ice for storage, which has specific handling requirements and is often incapable of providing ongoing temperature protection for longer periods of time.

An alternative method is the use of portable ULT freezers. These appliances are substantially easier to transport and operate virtually anywhere, as they can be plugged into standard power outlets and automotive DC power adaptors, without the handling concerns and limited temperature range of dry ice. Portable ULT infrastructure is ideal in decentralized scenarios where trained personnel may not be available at the patient location. Furthermore, since DCTs often last several months, portable ULT equipment can provide the continuous, remote operation that dry ice and compressor-based ULT freezers cannot.

ULT storage technology that can be easily and quickly deployed just about anywhere, combined with emerging cloud-based platforms for clinical trial management and patient monitoring, has helped create a new infrastructure at just the right time for DCT in this new era of advanced medical research.

Reduce Healthcare Distrust Among Underrepresented Communities

While DCTs could help solve many obstacles that stand in the way of more diverse clinical trials, increased education and awareness about the value and availability of clinical trials is also crucial. Oftentimes, groups that have been historically underrepresented in medical research are skeptical of healthcare systems and professionals. Providing these communities with educational resources and data transparency about the equitable benefits of clinical trials and drug testing can help reduce some of this mistrust. By encouraging diversity in medical research, organizations can alleviate many of the health disparities that exist today, while also increasing confidence in underrepresented groups.

 

Tim Root is Director of Marketing for Stirling Ultracold, subsidiary of BioLife Solutions, Inc. Tim’s career spans several B2B marketing leadership roles over the last 30 years, with nearly 10 of those years in commercial refrigeration and laboratory/life sciences technology. Working with Stirling Ultracold over the last 6 years, he has also engaged the ultra-low temperature (ULT) storage marketplace as a thought Leader, blog writer and laboratory sustainability advocate. Mr. Root holds a B.A. in Industrial Communications from Wright State University, enjoys freshwater fishing and lives with his wife of 37 years in Milford, Ohio. He can be reached at troot@stirlingultracold.com.

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