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March 21, 2023

The Rising Disparity Between Legal, Medical, and Clinical Trial Sample Chain of Custody

In our latest blog, we touched on how Slope's founders leveraged their e-commerce supply chain expertise to solve supply chain issues in clinical trials. This week, we are continuing that trend by looking outside the pharmaceutical realm of clinical trials and focusing on the legal and healthcare industries, in the hope of bringing much-needed innovation and awareness to the need for a clinical trial sample chain of custody overhaul.

The legal industry

Samples that are taken for legal purposes (drug tests, DNA for crimes, paternity) are reliant on airtight chain of custody procedures. Also known as a chain of command drug screen, an example taken from Clinical Laboratory News is as follows: 

Police sergeant A seizes the urine sample collected from the defendant, and police officer B transports the specimen to a crime lab. At the crime lab, staff member C receives the urine specimen and scientist D analyzes it, detecting the presence of benzoylecgonine, the inactive metabolite of cocaine, using gas chromatography-mass spectrometry (GC/MS). Scientist D gives the result to senior scientist E of the crime lab, who confirms the result.

A, B, C, D, and E would all need to sign the chain of custody forms, and the prosecution would need to offer testimony by each person in the chain to identify and establish the condition of the evidence showing that the defendant abused cocaine.

If any portion of the chain of custody is broken, the drug test results would be questionable in court. Ensuring conviction requires rigor that every step in the sample collection, transport, and analysis is documented and attested to.  

The healthcare industry 

Think of the last time you went to your doctor where a sample was required to inform your health or course of treatment. Everything ranging from allergy testing to liver function tests to cancer biopsies. Can you imagine what would happen if the sample from the patient (you, a family member, a friend) was misplaced, mishandled, or swapped?

Well, it happened to the husband of Slope's Chief Clinical Officer, Hope Meely. Hope's husband was experiencing some common symptoms that required routine blood tests, only to hear the news that his provided sample indicated he could be in severe cardiac distress. As a result, he was immediately hospitalized for further testing and procedures, thinking his health was at risk. It wasn't until two days later, after much worry, that he was told the test results were erroneous and not even his — they were from someone else's specimen. While there was both frustration and relief at the news, his health was intact. However, it is still unknown if the patient whose specimen was swapped was ever told that he or she was possibly experiencing a cardiac event.

You might ask, “How could this have happened?” While there are chain of custody forms and procedures for medical samples, there is not as much rigor placed on ensuring an airtight chain of custody, or the ability to trace back a sample to the patient from which it originated. Documentation and following of chain of custody still remains a very institution-specific process that relies on standard operating procedures and manual oversight. 

Why is a legal drug test more important than results that impact patient care? 

The pharmaceutical industry - clinical trials 

Now, let's bring this back to clinical trials. Biological samples are essential to prove the safety and efficacy of the investigational drug. Pharmaceutical companies are obligated to understand where this data comes from, and yet their visibility into sample chain of custody is pieced together by information that is gathered from their sites, CROs, and labs. Moreover, despite the samples' link to patient inclusion, safety, and efficacy data, the chain of custody for samples prior to receipt at a testing lab often is not considered a high priority unless a problem should arise.

So, what could possibly go wrong? 

Similarly to the healthcare scenario described above, patient samples can be lost, mishandled, or swapped. The patient could then be subjected to another (often painful) collection procedure; inclusion criteria could be not met; the patient could be withdrawn from the study completely; or worse, the patient’s safety could not be properly followed. Many clinical trial patients are extremely sick, making the collection of another sample difficult, or the removal from a trial devastating — especially if they have no other treatment options.

Here is another possible scenario: during the study, a patient needs to withdraw, and thereby also decides to withdraw their consent to use their samples. By regulatory requirement after withdrawal of consent, the sponsor is then obligated to find and destroy all of their samples. Without a traceable chain of custody, the sponsor is likely to spend significant amounts of time and resources tracking down those specific samples in conjunction with other parties – only to result in the inability to destroy the samples if patient attributability cannot be guaranteed.

Mistakes can and will happen when managing a high volume of samples across multiple sites, labs, CROs, and patients.

The takeaway

It is absolutely mind-boggling that we don’t treat medical or clinical trial samples with the same rigor as samples taken to convict criminals. 

As an industry, we need to start thinking about the sample chain of custody in a different way, as it impacts our health — both now and for the new treatments being developed to address so many diseases.

If you are looking for a better way, Slope can help.

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