Biosample Challenges in Clinical Trials

A few years back, at a biotech networking event, I described my role in the company as "A housewife," eliciting knowing laughter from biosample operations folks and blank stares from others. The disparity of these reactions made me realize the gap in understanding the process and the value of clinical trial operations even among seasoned pharma professionals. Like housemakers, operations tirelessly work on running a trial, ensuring everything and anything is done at the right place at the right time, and their true contribution to peace and happiness is only realized when things go wrong.

On any given day, droves of patients entrust parts of themselves —blood, biopsies, and the like—to the nurses at clinical trial sites. These samples embark on a journey from the sites to tumultuous courier docks, and finally into the bellies of lab freezers and analytical machines that yield data eagerly awaited by medical monitors, boards of directors, and investors. Amidst this romancing of data, the fundamental element—a sample from a willing patient—is often overlooked. Nevertheless, as my favorite chef Gordon Ramsay can attest, quality ingredients are crucial for both exquisite cuisine and the successful launch of a billion-dollar drug, dependent on the integrity of these initial samples.

Brenda Yanak and other Unicorns in the field passionately underscore the significance of biosamples in clinical trial outcomes. Her posts on this subject are always a worthy read! Companies like TruTechnologies, makers of TruLab prioritize the tracking of biological samples and strive to raise public awareness of the challenges in biospecimen management. In a recent webinar, panelists Carla W. and Dave Bourdet discussed the obstacles and strategies for handling biospecimens during the critical transition from early to late-stage development.

Key Takeaways (with my commentary in parenthesis):

?Observed Issues:

• Sites lacking experience with specifics of clinical trials;
• High staff turnover and inadequate training for those handling samples;
• Lack of documentation for the samples' journey;
• Disconnected processes between data generation and sample collection;
• Mix-ups of samples in bioanalytical laboratories.

?

When things go wrong:

• Late-stage trials may discard 20-30% of PK/PD data due to unreliable or missing sample information;
• Due to sparse sample collection in large studies, missing data introduces bias into the study and leads to challenges in final dose determination;
• Contaminated samples or flawed sample custody can undermine analysis quality, leading to FDA rejection of drug applications.

Suggested Solutions:

• Choose sites with proven experience in clinical trials;
• Utilize sites adept in advanced sample-tracking technology ( Slope is a wonderful example of an ingenious approach to this conundrum offering free sample-management services of their platform to the sites);
• Opt for premium couriers providing re-icing, lane mapping, and detailed package tracking;
• Ensure constant awareness of sample locations (one of the veterans and trailblazers in this field is LabConnect which offers real-time sample tracking through its digital pen technology - an essential service that is shamefully not a standard in other central laboratories);
• Regularly update sites on changes to sample collection protocols;
• Assign dedicated roles within companies to oversee sample tracking;
• Implement comprehensive and continual site training (moving beyond PowerPoint to innovative methods like those offered by Pro-ficiency (a Simulations Plus company) that focus on simulated training with real-time monitoring of comprehension);
• Maintain ongoing sample reconciliation for consistent results.

For those interested in the full webinar on biospecimen challenges, visit TruLab's website: https://lnkd.in/ev_i_u4g

I would love to hear your thoughts and your challenges with clinical biospecimens!

?#samplemanagement #clinicaltrials #dataintegrity #FDA