January 9, 2024

How Does Execution of the Lab Manual at Research Sites Impact Sponsors?

Lab manuals are an integral resource in the vast majority of clinical trials. In coordination with CROs and various lab vendors, sponsors will compile lab kit management and sample management procedures for their trial into one concise document that offers guidance to their research sites.

But how do lab manuals hold up in today’s environment of complex clinical trials? Confounded by various visits, lab kits, time points, sample types, shipping frequencies, and shipping destinations, complicated sample management procedures are synthesized into a dense document that is cumbersome to sift through, prone to misinterpretation by busy site personnel, and subject to frequent changes due to protocol amendments and other study modifications. 

This prescriptive document may be considered a site-centric study document; but why should sponsors be mindful of how their sites are using the lab manuals for their trials? This blog explores the characteristics of today’s lab manuals that are putting your study’s data integrity at risk. These risks not only intensify patient burden, but they necessitate more data reconciliation, inhibit critical decision-making, and delay overall study timelines. 

How can lab manuals put your clinical trials at risk?

Lab manuals may have all of the information that research sites need to manage lab kits and patient samples for a trial, but that doesn’t mean they inherently set sites up to be successful. So what can make them unreliable sources for guiding lab kit management and sample management?

Lab manuals are dense

Most of today’s trials are incredibly complex. Factors like precision medicine and dose escalation demand more visits, more time points, more sample types, more lab kits, and more lab vendors. Each lab kit and each sample within each lab kit comes with its own unique set of instructions for collection, processing, storage, and shipment — making the lab manual an incredibly dense document. Site personnel are left to sift through many pages in search of sample management instructions for a specific visit or a specific biospecimen. The process of manually navigating through this information may not only compromise precious research site time, but it may also lead to accidental oversights by site personnel. Phlebotomists or study coordinators may accidentally misread an important sample collection procedure, forget a stored sample in a freezer, ship a sample to the wrong lab, or forget to collect a sample altogether, all because they overlooked one step in the lab manual.

Research sites don’t have the best tools for integrating lab manuals into their pre-existing processes

People who work in clinical research understand that the one thing that research sites have in common is that they are all different. This idea manifests itself in clinical trial sample management, wherein every site has its own unique process for managing lab kit inventory, patient samples, and specimen data. Because of this, many research sites — especially large research institutions — must take sponsor lab manuals and integrate them into their own workflows. It’s not uncommon for research sites to create their own sample management templates — abbreviated, visit-specific blueprints that take the specific instructions in the lab manual and distill them down into more digestible steps that phlebotomists, nurses, lab techs, and study coordinators can follow when managing patient samples and biospecimen data. Because this practice is highly manual and variable from research site to research site, it introduces a lack of standardization into sample management processes that can hinder sponsor oversight. 

Lab manuals are updated all the time

Lab manuals can be considered extensions of the protocol — and as such, they may be prone to changes resulting from protocol amendments. Other study modifications that may impact clinical inventory, shipping destinations, and shipping frequencies for certain samples, etc., may not originate from a protocol amendment, but may still have a direct impact on the lab manual. As a result of these frequent changes, research sites may be at a heightened risk of sampling compliance issues; perhaps they use an outdated lab manual or lab kit to execute a patient visit that should have been performed under a more current version of the lab manual. When critical samples go uncollected or are otherwise mishandled, a trials’ data integrity can be put in jeopardy.

What Do Lab Manual Limitations Mean for Sponsors?

Elevated patient burden

Clinical trials already demand a significant commitment from patients who are oftentimes dealing with a chronic condition or life-threatening disease. When critical patient samples are mismanaged, it can create an undue physical burden that exceeds what the patient consented to at the beginning of the trial. Patients may be required to travel back to a research site for sample re-draws, or otherwise may be forced to drop out of a study entirely as a result of an inability to make a timely, critical patient treatment decision. 

Increased EDC and lab data reconciliation

When sites do not comply with prescribed lab manual instructions, it inevitably generates downstream lab queries and EDC queries. The process of resolving these queries can divert valuable resources from site personnel, site monitors, and even sponsor study managers who may need to urgently resolve these queries for the reporting of patient results, database locks, and more. 

Study delays

When patient samples are mishandled or not collected due to accidental oversights in the lab manual, it can introduce significant risks to major study milestones — including interim analyses, dose escalation decisions, patient treatment decisions, protocol amendment decisions, study closure, and more. Sponsors are expected to produce a complete and accurate data set when submitting their data to regulatory authorities for review — but gaps in this data may necessitate more data that supports study integrity, justification for critical study decisions, and a drug’s safety and efficacy. The need for additional data — and the time that it can take to address data anomalies — can introduce costly delays that hinder accelerated drug development.

How Can Sponsors Make Their Lab Manuals Easier to Use?

Lab manuals aren’t going away, but one thing is clear: sponsors need to equip their research sites with tools that they will willingly adopt to ensure that they are able to be more efficient and compliant with managing patient samples. 

To learn more about how you can de-risk your study data by using technology to augment the utility of your lab manuals, click here.

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