February 20, 2024

3 Ways to Fine-Tune Your Clinical Trial Monitoring Strategy to Minimize Protocol Deviations

Protocol deviations are an all too familiar challenge during clinical trials. Yet despite their frequency, it’s vital to recognize the significant impact that deviations can have on both data integrity and patient well-being.

Deviations stand as one of the primary obstacles to maintaining accurate, compliant study data and ensuring a smooth patient journey throughout the trial. Whether it’s a missed sample collection, mishandled specimen, out-of-window visit, or a lapse in obtaining informed consent, each of these scenarios poses a threat to the reliability of collected data. Such setbacks can lead to critical delays in study progression and compromise the validity of trial outcomes.

Beyond the logistical hurdles, deviations directly impact patients. The need for sample redraws can compound patient burden. Even worse, a patient may be forced to screen-fail or drop out of a study as a result of biospecimen errors.

One of the primary purposes of clinical trial monitoring is to prevent and address protocol deviations. But given the high stakes of these compliance issues, clinical operations professionals need to optimize their monitoring plans to prevent and quickly identify deviations. What does this look like in practice?

Enhance study oversight by enabling real-time monitoring

Centralized monitoring provides sponsors with a comprehensive view of biospecimen data and performance across multiple sites, facilitating early detection of protocol deviations and other quality issues. By consolidating data into a centralized platform, sponsors can identify trends, outliers, and potential risks more effectively.

Unfortunately, not all solutions that enable centralized monitoring also enable real-time access to critical biospecimen data, allowing sponsors to proactively address issues before it’s too late. For instance, many sponsors may rely on EDC data for certain monitoring activities, but EDCs are infamously susceptible to data lag. In fact, one journal article found that the average lag between a patient visit and data entry into the EDC is 8.1 days.

By enhancing oversight and transparency, centralized monitoring fosters collaboration among stakeholders and promotes adherence to protocol requirements. Leveraging centralized monitoring tools and technologies also enables sponsors to streamline monitoring activities, improve data quality, and ensure the integrity of their biospecimen data.

Harness risk-based monitoring for proactive prevention

Risk-based monitoring (RBM) offers a proactive approach to identifying and mitigating risks in clinical trials, including the occurrence of protocol deviations. Unlike traditional monitoring methods that rely on 100% source data verification, RBM focuses on identifying critical data and processes that are most susceptible to risk. By leveraging risk assessment techniques, RBM enables sponsors to allocate monitoring resources efficiently and effectively. 

By adopting a risk-based approach, sponsors can prioritize resources where they are most needed, thereby reducing the likelihood of protocol deviations. Implementing RBM strategies empowers sponsors to detect issues early, intervene promptly, and maintain data quality throughout the study lifecycle. 

With that in mind, it's important for sponsors to consider addressing deviations at their root cause. Think about the site processes that are susceptible to error and contribute to protocol deviations. 

Integrate clinical inventory and sample management into RBM and centralized monitoring practices

Effective management of clinical inventory and samples is essential for ensuring the integrity and reliability of biospecimen data. By integrating inventory and sample management — which are at the root of many protocol deviations — into your monitoring strategy, sponsors can streamline their clinical operations and reduce the risk of downstream issues.

Implementing robust inventory management systems enables sponsors to track the receipt, storage, and distribution of lab kits, bulk supplies, IP, devices, shippers, and more. Similarly, sample management systems facilitate the tracking and documentation of sample collection, processing, storage, and shipment throughout the trial. By integrating these critical aspects of the biospecimen lifecycle into their monitoring practices, sponsors can minimize preventable oversights and maintain compliance with protocol requirements. Effective management of clinical inventory and samples enhances data quality, supports regulatory compliance, and ultimately contributes to the success of clinical trials.

Stop protocol deviations in their tracks

Slope’s clinical trial execution platform can minimize the impacts of protocol deviations in two ways: 1) by preventing certain protocol deviations entirely, and 2) by mitigating the impacts of certain protocol deviations before it’s too late.

The platform’s guided workflows support site operations by enforcing guardrails during sample collection, processing, storage, and shipment. This process ensures that critical samples are collected every time, and provides certain checks along the way to ensure that samples are being processed, stored, and shipped per lab manual procedures.

When sites perform sample management directly in Slope, the platform grants sponsors with instant access to biospecimen data. Departures from expected sample management steps can be easily detected in real time, enabling sponsors and monitors to intervene if and when necessary.

Interested in learning more about how Slope can transform your trials? Be sure to check out our white paper on how our software platform can de-risk your trial by turning your complex lab manuals into software-guided workflows.

To explore the other ways in which today’s clinical trial landscape is hindering sponsor monitoring strategies and research site compliance, check out our guide, "Dissecting the Link Between Clinical Trial Monitoring and Research Site Compliance."

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