Do Sponsors Care About Clinical Trial Participants?

Rethinking Biospecimen Collection: Less Burden, More Inclusion, Better Science.

A man was crying. His body – a meaner version of Shaquille O’Neal – made the flimsy hospital bed creak under his weight, daring the 600-pound limit printed on the manufacturer’s tag. The pre-op ward’s nurse and I were at a loss.

“I’m done,” he sobbed, smearing tears thick over his face, “I told ya - I’m ‘fraid of them needles!”

I took a slow breath. “Well, Sir, I completely understand your hesitation, and I absolutely respect your decision not to continue with the study… but we still need to collect some samples – just to make sure you are okay. Doctor's orders.”

I could not believe my own words. The man was absolutely perfect - the first African American to qualify for the study, checking off 29 of the protocol’s inclusion and exclusion criteria. And now, he was slipping away—not because of science, not because of safety concerns, but because it was simply too much.

I stepped out of the tiny room, his sobs now a low, desperate howl - like a wounded whale calling into the void.

 Sadly, this wouldn’t be the last patient I lost to the weight of clinical trial demands.

Inside the World of Biospecimen Collection: The Current State

While a drama like this is not mainstream, and most study participants solder on enduring pokes, recollections, and endless site visits, every time I look at yet another ambitious schedule of events, I can’t help but think, “You’ve got to be kidding!”

Why the exclamation, you might ask? Well, let’s break it down.

A typical clinical study often demands 15 or more site visits, each stretching for hours. That’s a substantial time commitment—time away from work, family, and the simple joys of life. And if you require a caregiver? That’s their time, too.

Then, there’s the blood work. A routine chemistry panel? 5mL. A complete blood count? Another 5mL. Infectious disease screening? Tack on 10mL. And that’s before we even start with pharmacokinetics, biomarker analysis, exploratory research, and those “just-in-case” collections. The numbers add up fast.

At each visit, a participant might part with anywhere from 10 to 90mL of blood. Over the course of a study? That could easily exceed 1,000mL—more than a liter. For many, this is simply an inconvenience. But for some—especially those with underlying health conditions—these frequent draws can pose real risks.

And yet, we expect patients to endure it all. With a smile.

What’s Wrong with the Current State of Sample Collections?

While this approach has been the norm for years, it's becoming clear that it's not aligned with the future of clinical research. Here's why:

Reduced Patient Diversity

The demanding nature of current collection protocols creates significant barriers to diverse participation in clinical trials:

• Underrepresentation of minorities: Despite ongoing efforts to improve diversity, racial and ethnic minorities remain significantly underrepresented. For example, while Black/African Americans make up 13.4% of the U.S. population, they account for less than 5% of clinical trial participants.

• Socioeconomic barriers: Frequent site visits disproportionately impact individuals from underserved or rural communities who lack the time, transportation, or financial flexibility to participate.

  
  

Participant Burden

The current system places a heavy burden on participants, making retention a major challenge:

• Frequency of visits: Most clinical trials demand 12–15 site visits per study, with some complex protocols requiring even more.

• Travel distance: In a survey of clinical trial staff, 77% cited travel distance as one of the biggest barriers to patient enrollment.

  
  

Limited Biomarker Analysis

Strict ethical limits on blood collection can restrict critical biomarker research:

• Missed opportunities: These constraints may lead to lost insights—limiting our ability to discover key biomarkers or fully understand drug effects across diverse populations.

Needle Phobia and Emotional Toll

Frequent blood draws and invasive procedures aren’t just physically demanding—they take a psychological toll as well.

• Anxiety and stress: For the 25% of U.S. adults with a fear of needles aka. trypanophobia, repeated blood draws can be overwhelming. Of those with severe needle anxiety, 16% actively avoid medical care, potentially excluding them from crucial trials.

• Emotional burden: The cumulative impact of frequent hospital visits, invasive procedures, and prolonged study commitments can lead to participant fatigue and dropout.

• Impact on data quality: Stress and anxiety don’t just affect patients—they can also influence the quality and reliability of the data collected.

  
  

The Roadblocks to Effective Patient-Centered Biosample Collection

Despite growing awareness of the need for more patient-centered approaches, several significant roadblocks hinder the adoption of innovative biospecimen collection methods in clinical trials.

Let's take a closer look.

Resistance to Change

The clinical research community has long relied on traditional methods—and many are reluctant to deviate from familiar practices:

• Comfort with tradition: Researchers and clinicians often stick with what they know, hesitant to embrace new approaches.

• Risk aversion: A study in the Journal of Clinical Epidemiology found that only 40% of clinical trials used at least one patient-centered outcome measure, highlighting the slow adoption of patient-centric practices.

• Regulatory concerns: Uncertainty about regulatory acceptance can stifle innovation. For instance, the FDA only recently issued guidance on using digital health technologies in clinical investigations.

Knowledge Gaps

Limited awareness of cutting-edge biospecimen collection techniques often prevents their adoption:

• Limited exposure: A survey of clinical trial professionals revealed that just 33% were very familiar with decentralized clinical trial methods.

• Rapid technological advancements: The pace of innovation in biospecimen collection can outstrip researchers' ability to stay informed and implement new methods.

Organizational Silos

Within biotech companies, communication gaps between teams often slow the adoption of patient-centered approaches:

• Disconnected departments: Protocol designers may not effectively collaborate with operations teams or biospecimen management experts.

• Late-stage involvement: A Tufts Center for the Study of Drug Development survey found that only 10% of companies engage patients during protocol design—missing critical early insights.

• Lack of interdisciplinary collaboration: Research shows that interdisciplinary teams drive more patient-centered outcomes, yet many organizations struggle to foster this level of cooperation.

Laboratory Limitations:

Not all labs are equipped to handle alternative sample types or smaller volumes, creating technical barriers to adoption:

• Equipment constraints: Many laboratories are set up for traditional sample types and volumes, making it challenging to integrate novel collection methods.

• Validation hurdles: New methods and method transfers require extensive validation—a process that can be both time-consuming and costly.

Regulatory Uncertainty

Concerns over regulatory acceptance remain a significant barrier to innovation:

• Lack of clear guidelines: While regulatory agencies are becoming more open to novel approaches, concrete guidelines for many collection methods are still evolving.

• Data integrity concerns: Regulators may question whether alternative collection methods provide data that is as reliable and comparable as traditional approaches.

  
  

Moving Forward

Overcoming these roadblocks is critical for advancing patient-centered biospecimen collection in clinical trials. It will take a coordinated effort from researchers, biotech companies, laboratories, and regulatory bodies to drive innovation while maintaining scientific rigor and patient safety.

At the end of the day, though, fewer men will cry on our watch.