Unmasking the ‘Centricity’ Illusion in Clinical Trials

During my 25 years working in clinical trial operations, I’ve seen the biopharmaceutical world talk a big game about making the process easier for the sites running the trials and the patients participating in them. Everyone from trial sponsors to the Food and Drug Administration has been quick to promise simpler processes, less hassle, and better experiences for everyone involved.

But look closer, and you’ll see that these grand promises often fall apart when sponsors implement complicated plans for collecting blood, tissue and other biospecimens and impossible processes for managing those samples. Behind all the talk and regulatory guidance, there’s a reluctance to change how these essential elements of clinical trial execution are handled, putting the very ideals that sponsors are trying to uphold at risk.

The concept of site and patient centricity frequently gets reduced to addressing only superficial gestures, such as committing to promptly paying sites for their work or using tablets for conducting patient surveys. But the essence of centricity extends far beyond these surface-level measures. It lies in addressing the unseen and unmentioned complexities of clinical trials and providing real solutions that focus on truly prioritizing the needs of trial sites and participants.

In my experience, superficial gestures happen all the time. For example, a small biotech company I once worked for was getting ready for its first-ever venture into early-phase research on advanced solid tumors. Doing so meant competing with well-established big pharma players for the same resources — sites and participants — to make the research happen. The company set out with a good intention: to help research sites become the place where participants wanted to receive treatment.

The reality didn’t live up to the vision. The company’s traditional study design involved multiple in-person visits for patients and a complex plan for obtaining a variety of patient samples, including standard blood draws, biomarker studies, and tumor specimens. Under this plan, each site had to process some samples given by participants right away and send them out on the same day. Other samples were stored on-site for later use, each one requiring different processing and storage conditions. Sites were left to find ways to deal with this complexity on their own. As a result, instead of focusing on creating an optimal experience for participants, they had to focus on handling the complexity of managing their biospecimens.

Scenarios like this leave research sites short on the supplies they need for important patient visits. The samples they collect do not have a clear audit trail, resulting in lost samples, issues with patient attrition, and asking for duplicate samples from participants who are already bearing the burden of a condition or illness.

While sampling plans, inventory management, and sample management might not be the most exciting parts of clinical trials, they lay the foundation for a successful study. These elements are crucial for data integrity and patient safety and directly affect the patient experience from how often they need to come into a research site to what procedures they must undergo. But they are often given short shrift.

One way the biopharma industry — including clinical trial sponsors — can enact change is by fully embracing technology that reduces manual work and simplifies site processes. (It’s what my company, Slope, aims to do for trial sites.) Technological advances have revolutionized many parts of clinical trial execution. But inventory management and sample management somehow still rely on old-fashioned paper records and manual tracking systems. The clinical trials industry needs to start using centralized, digital tracking systems that are equipped with real-time monitoring capabilities and predictive analytics that facilitate efficiency and compliance, enabling research sites to focus on what matters most: taking care of their participants. Sponsors need to find solutions that facilitate sample management procedures traditionally prescribed in the lab manual. This approach not only improves compliance with sample collection, processing, storage, and shipping, but it unlocks real-time insights for sponsors who want to monitor site activity and performance, study trends, and more. Software-guided sample management workflows can also be used to automatically capture sample metadata that must be maintained with the sample.

Patient-centricity in inventory and sample management ultimately means making the process of being in a clinical trial as easy as possible for participants. This includes making sample collection schedules easier, using less invasive collection methods, reducing samples whenever possible and getting the most out of every generously provided sample. To get there, it’s important to give participants a say in how a trial is designed to ensure they have a smooth and dignified experience during the study.

The glacial pace of change in these mechanistic but essential areas undermines the industry’s claims of progress and compassion. Clinical research sponsors need to drop the act, embrace technology, improve their processes, and prioritize the well-being of research sites and trial participants.