A clinical trial’s operational efficiency depends on a solid oversight and response mechanism. Without vigilant monitoring, patient safety, data integrity, and the overall health of your trial come into jeopardy. How you approach that oversight also affects clinical trial success.
FDA advises sponsors to take a risk-based approach to oversight. Take advantage of technology that improves efficiency it states in guidance documents, but by all means, develop a process to identify prospective risks. Develop a plan to prevent or mitigate those risks early and often.
As we explain in our trial rescue white paper, early intervention—whether it’s providing additional training for site staff or bringing in a second CRO—is key to ensuring a study runs as smoothly as possible. That same “better early than late” concept also applies to oversight.
Why Oversight?
The average clinical trial generates up to three million data points.1 Considering this volume of data, as well clinical trials’ increasing complexity and geographic dispersion, strong oversight has become more challenging and important than ever.
Strong oversight starts with quality data and continues with regular review of that data in a holistic way. Monitoring data regularly will help you detect glitches before they blossom into catastrophes, which helps move your trial forward.
We’ve noticed two common approaches to oversight and response. Both have the potential to ensure a study completes while keeping complexity and overhead low. Like chocolate and peanut butter, they’re two good processes that work better together.
1. The Regular Review
The easiest and most unobtrusive way to ensure your trial adheres to its plan is to schedule an early full review. How early is early? Take a holistic look at your study within the first three months of initiation.
Three months gives sponsors time to see if they’ve made realistic forecasts. It’s also early enough in a study that it can take corrective action if needed without making drastic changes. During an early review, evaluate the following:
- Site activations
- Patient enrollment
- Regulatory approval
- Logistics and materials
The more areas you evaluate, the more thorough the analysis. How deep you dive depends on the company, the drug, and the therapeutic area. A dermatology trial that involves a few U.S. sites may not need as extensive a review as a biologic for a rare oncology indication with sites in the U.S. and Europe.
Repeat this type of review regularly during the course of a trial to monitor progress and address any glitches as they arise.
2. Continuous Monitoring
Continuous monitoring requires more up-front work and commitment, but produces deeper insight in a more manageable manner. Continuous monitoring is predicated on the idea that automation and artificial intelligence (AI), including machine learning, find incongruities faster and more accurately than a manual human review.
A properly implemented data platform can collect, track, and alert you to issues that might put your trial in jeopardy long before a human reviewer would have caught those issues. Small deviations from initial plans can be recognized by algorithms and highlighted in a way that’s clear and easy to understand.
A machine can detect patterns in data across sites that indicate potential fraud. It can also monitor sites for data bias or random error more frequently and quickly than in-person visits.
For all the benefits of AI for clinical trials, the technology has only recently become practical to implement—both financially and technically.
Biorasi’s TALOS™ dashboard incorporates some of these features, and we’re constantly adding more. Other CROs have their own proprietary dashboards and monitoring platforms, though few take full advantage of the power of machine learning and data analytics.
The Value of a Checkup
Whether you oversee your trial via a regular review or continuous monitoring depends on its unique needs and capabilities. Whichever method you choose, contract with an independent third party to conduct your oversight program. And in the interest of objectivity, make sure your third party vendor or contractor is truly independent; meaning, no direct ties to a stakeholder.
Another option: take advantage of Biorasi’s study health assessment. Our high-level independent trial audit reviews trial processes, milestones, progress, and gap analysis. We compile that information into a full report that gives recommendations on how to take your study to completion.
Our checkup takes about a week to complete, requires a minimum amount of confidential or proprietary information, and it’s free! Get in touch to find out more.
Whether you schedule an early review with periodic updates, continuous monitoring, or some combination, spend time developing an oversight and response plan. Patient safety, data integrity, and clinical trial success depend on it.
Resources
- Institute of Medicine (US) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices; Davis JR, Nolan VP, Woodcock J, et al., editors. Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report. Washington (DC): National Academies Press (US); 1999. Final Comments. Available from https://www.ncbi.nlm.nih.gov/books/NBK224576/
