Clinipace

The FDA has begun encouraging drug developers to take a risk-based approach and turn to new technology to help them monitor clinical trial work, according to Outsourcing-Pharma (Risk based centralised trial monitoring wanted by FDA) and Pharmalot (FDA urges remote monitoring of clinical trials).

In a new set of proposed guidelines, regulators encourage sponsors to monitor clinical trial quality without the need to visit sites as frequently. The FDA guidance also endorses transferring the responsibility of monitoring to a CRO.

We couldn’t agree more! Check out our latest client success story using the Just-in-Time Monitoring approach.

But, it’s important to select a CRO that aligns its processes with this methodology in mind. Improved technology adoption and clinical operations processes are now making it possible to redefine the role of clinical monitoring (within the context of trial operations), while at the same time decreasing costs and increasing clinical trial oversight. At Clinipace Worldwide, our Just-in-Time Monitoring methodology is ahead of the curve, already dramatically changing the way we interact with our trial sites.

Because the electronic clinical systems of a digital CRO enable real-time trial enrollment visibility and confer the ability to identify and resolve data discrepancies remotely, the need for site visits is reduced. Clinical research associates (CRAs) on a technology-amplified study do not have to travel as much as they did in the traditional model. By employing a just-in-time monitoring approach (enabled by the digital CRO model), CRAs can obtain the information they need and travel to the site only when justified based on pre-specified criteria such as accumulation of data, queries, or other triggers such as a serious adverse event or protocol deviation.

We’re pleased to see the FDA validating what we’ve been practicing for years, and look forward to seeing more overall success in the industry based on this innovative shift.

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According to a recent industry survey, on-site clinical trial monitoring is estimated to account for up to 30 percent of study costs and, according to some, is very inefficient. The results published in a coinciding research paper by members of the Clinical Trials Transformation Initiative (CTTI) suggest that sponsors are missing an opportunity for significant increases in clinical trial efficiency, specifically in monitoring processes. More monitoring does not mean more quality.

Careful monitoring is a necessary and important part of any clinical trial — so necessary and important, in fact, that it has changed very little over the history of conducting clinical trials. Required by both U.S. and international agencies, clinical trial monitoring helps ensure the integrity of the data, the consistency of the science, and of course, the safety of the patient.

Today’s clinical research associate (CRA) may monitor several concurrent studies, with all the associated travel, management and reporting responsibilities. Burnout is a constant problem, as CRAs endure separations from their homes and families while fulfilling their professional responsibilities at multiple sites. It can be a challenge for clinical research organizations (CROs) to retain trial monitors due to the demands of the job.

However, improved technology adoption and clinical operation processes are now making it possible to redefine the role of the CRA, while at the same time reducing stress, decreasing costs and increasing clinical trial oversight. At Clinipace Worldwide, we’ve adopted a methodology called Just-in-Time (JIT) Monitoring that is dramatically changing the way we interact with our trial sites. With JIT monitoring (enabled by the digital CRO model), CRAs can obtain the information they need and travel to the site only when justified based on pre-specified criteria such as accumulation of data, queries, or other triggers such as a serious adverse event or protocol deviation.

A key aspect of realizing the benefits from just-in-time monitoring is to actually incorporate the data-driven model into clinical trials. Many study sponsors and sites are using technology to collect and store trial data, but haven’t taken the next step to integrate the data from disparate systems into meaningful information.

In these cases, technology-amplified service delivery is not much more useful than collecting it manually, and in fact adds an extra step to the process. To avoid being burdensome, data collection tools must be incorporated into the overall study framework in a way that encourages their use as part of conducting the trial. Furthermore, the data from laboratory and clinical systems must be viewed as a whole in order to glean real intelligence from the data stream.

Ultimately, data-driven solutions result in enhanced outcomes for the research sponsors and better relationships with the sites. And providing cleaner data on time and under budget can make CROs more successful.

While just-in-time monitoring is an excellent way to increase efficiencies and reduce costs, it doesn’t remove the need for careful on-site monitoring to ensure adherence to protocol and attention to patient safety. However, it can elevate those on-site visits to make them more focused, more strategic and less disruptive to patient care.

Check out this client case study (Inspire Pharmaceutical, acquired by Merck), and how our dCRO service delivery can work for you.

Just in Time Clinical Trial Monitoring Client Case Study

[More discussion on targeted SDV can be found in the latest version of Applied Clinical Trials. Sponsors and project managers should develop SDV strategies for each trial that comply with regulatory requirements and accommodate the size, complexity, design, and purpose of the trial.  One hundred percent SDV, the comparison of each data point on every case report form (CRF) to subject medical records, may not be appropriate for most large, multi-center trials. Targeted SDV—the verification of critical trial data, including study endpoints—has the potential to improve safety oversight, data quality, regulatory compliance, protocol adherence, and overall trial validity while reducing costs and the time to database lock for large, multi-center trials.]

We’ve had it! Enough with 100% SDV. It’s simply not needed and a waste of time and money.  The CenterWatch Monthly ran an article in their February issue on the high cost and questionable impact of 100% source data verification (SDV). Source data verification checks that the data collected on a research study can be verified by looking at a primary source, such as a medical record, in essence, checking for consistency and accuracy in transcribing data from one place to another.

Despite no evidence that it improves data quality, a highly conservative interpretation of FDA regulations regarding data monitoring has led to 100% source data verification becoming standard industry practice. FDA regulations do not require monitors to check every source data point at each and every investigative site. Plus, this approach is costly, time-consuming and diverts attention and resources from more critical clinical trial activities. Yet, many drug companies believe its best way to ensure the validity and integrity of clinical trial data.

So, what is the driving force behind this practice? When validating clinical trial data, the old adage of quality trumping quantity SHOULD ring true, but when it comes to data monitoring it often does not. Many clinical trial operators don’t understand data qualification and data verification are not synonymous. Without the proper people, SOPs, and technology in place, many clinical trial sponsors believe 100% SDV is the only way to ensure clean data – they’re being reactive rather than proactive.

As companies have begun to take a hard look at all trial costs (monitoring is one of, if not the largest expenses), they are revisiting monitoring processes in search of more efficient means of leveraging prior site performance in hopes of more effective trial management.

Beginning with the end in mind makes for a controlled sampling methodology for selecting source data to be verified in any clinical trial.  Improved technology adoption and clinical operations processes are now making it possible to redefine the role of the CRA, while at the same time reducing stress, decreasing costs and increasing clinical trial oversight. At Clinipace Worldwide, we’ve adopted a methodology called Just-in-Time Monitoring that is dramatically changing the way we interact with our trial sites.

With just-in-time monitoring, a CRA can view a variety of data elements remotely and immediately detect any outlying or troublesome data. An improved level of visibility into the data means that small problems can be spotted early and don’t have the opportunity to develop into larger problems that might slow the study or endanger a patient.

Remote monitoring that includes complete data visibility makes it possible to implement corrective actions and get nearly immediate feedback on the effectiveness of those actions. Slight alterations in course early on avoid the need for gross adjustments later.

Constant monitoring of trial data and site performance also help to make visits more efficient and purposeful. Instead of having to spend days looking at everything, a CRA is able to pinpoint exact areas that need to be addressed while on-site. This allows visits to become more strategic in nature, where the CRA and site personnel work together to solve specific problems and set future goals.