Sponsors can group information that comes out of any clinical trial testing into two main categories: 1) the data collected and, 2) all activities supporting the collection and reporting of the data. Reliance on one without the other provides sponsors with an incomplete view to adequately assess clinical trial performance and data integrity. Clinical Monitoring Oversight offers sponsors an objective onsite evaluation and assessment of a trial site’s conduct — and provides crucial information about a trial and site performance that is most often completely undetected from the data itself.
Sharing his extensive experience with Clinical Monitoring Oversight, John Wilson, Ph.D., Senior Vice President and Chief Quality Officer at Beaufort, answers questions about data blind spots, and how proper monitoring oversight bridges the gaps.
Q: Why is Clinical Monitoring Oversight so important?
A: First, let’s think of the more fundamental question “How does a sponsor know if their CRO is doing everything it should be doing to conduct a high-quality study and adequately protect the safety and rights of human subjects?” This question is increasingly asked by regulators as well as sponsor stakeholders. Clinical Monitoring Oversight provides the answer in a manner that allows the sponsor to have complete confidence in the data, and not worry about losing data or a study due to lack of oversight. In short, it’s about your ability to defend your study to a regulatory agency when it comes time for end-of-trial reporting and readiness.
Q: What information can Clinical Monitoring Oversight provide that data can’t?
A: Data may be able to tell a sponsor that something is incorrect or missing, but it will never tell them why, or what an appropriate corrective action might be. Through Clinical Monitoring Oversight, on the other hand, you can truly get to the root cause of a non-conformance.
For example, you might be able to see from a data readout that a site is averaging thirty days to respond to queries, when it should not be taking that long. However, the data doesn’t tell you the cause of the delay. From Clinical Monitoring Oversight, you can learn that the study coordinator might be overworked from managing eight different studies, or that they are simply not as fast or efficient as required to meet timelines. Those nuanced insights that data alone would never reveal allow you to accurately identify the “why” of issues — and more quickly respond with corrective action.
Q: Is it important for oversight monitors to be onsite to conduct these assessments?
A: We’ve found that one of the most critical success factors for sponsors in the management and execution of their clinical trial is to have highly qualified oversight monitors at the trial sites, engaging with principal investigators (PIs), site staff, and clinical research associates (CRAs). Through their high level of interaction with everyone involved in the trial process at the site, oversight monitors are able to quickly identify and facilitate the correction of issues, some in real time, that would never have been captured by processes such as data cleansing, exception reports, and artificial intelligence (AI).
Q: So Clinical Monitoring Oversight also helps to assess site staff performance?
A: Absolutely. It’s integral for evaluating the work of all key site staff. Let’s stop and realize that the role of site staff in a clinical trial, whether PI, Study Coordinator, or any other role, is a difficult job with many moving parts. Other demands can reduce the time and focus required for a clinical trial – and result in underperformance or deviations from the protocol that impact the integrity of the data.
One of the most critical success factors for sponsors in the management and execution of their clinical trial is to have highly qualified oversight monitors at the trial sites.
By relying solely on data, sponsors can miss excellent performance, as well as performance that falls below expectations. A strong CRA can make a mediocre site look better, or a mediocre site can make an exemplary CRA look like they are not doing their job. Further, a CRA can do everything possible to handle a situation, but a site may simply not be performing to the standard required. We have found that it’s important to divorce site performance and CRA performance from one another, which you can’t do in a database. An objective observer, such as an oversight monitor, can more accurately evaluate a CRA’s qualification and suitability.
Q: Are there any other areas where Clinical Monitoring Oversight can provide insight?
A: Inspection readiness is another critical element that can be evaluated by an oversight monitor in a manner that won’t necessarily show up fully in database reporting. Take, for instance, the case of informed consent one of our oversight monitors recently encountered: Everything was going smoothly from all measures, and the CRA was engaged and performing at a high level. However, the oversight monitor discovered that the study population was primarily composed of people who are illiterate, and only a checkbox denoted that informed consent had been obtained. There was no documentation of this activity that would have been evident in a database. Even though the CRA was doing an excellent job in every other way, they did not have time to check every detail. However, the oversight monitor was able to pick up on this detail and elevate to the sponsor immediately. That level of oversight can be crucial when it comes time for inspection.
Q: What should a sponsor look for in hiring a company to perform Clinical Monitoring Oversight?
A: There are many factors a sponsor should consider when selecting a partner. A strategic approach will help the sponsor evaluate whether the partner has the right qualifications to match your needs and, importantly, will be equally invested in your success. Some key factors to look for are: Do they have the relevant experience, qualified staff, local resources, technology infrastructure, and operational expertise to support the outcome of your trial?
Beaufort has decades of experience providing leading health science companies with Clinical Monitoring Oversight. Our proven process helps proactively assess CRA and site performance, ensure participant safety, maintain data integrity, and demonstrate to regulatory bodies that your trial meets the highest scientific, ethical, and regulatory standards.
You can also watch Dr Wilson’s webinar “What Data Alone Won’t Tell You: The Rising Value of Clinical Monitoring Oversight” presented at the 2nd Annual Clinical Oversight Conference.
Learn more about Beaufort’s Clinical Monitoring Oversight