The adage “time is money” is as pertinent to clinical research as to any other corner of the business world. The longer a study drags on, the bigger its price tag becomes. Study timelines can be a source of much anxiety for researchers, creating the markets for time-saving innovations like EDC, eSource, and risk-based monitoring. Recent trends are not easing this anxiety: a study by Cutting Edge Information finds that early-phase clinical trial budgets increased 157% between 2008 and 2013, with the biggest spike, of $23,600 per patient, occurring in Phase I. Now, several years removed from this time frame, there is evidence these trends are continuing. The study cites a shift toward more complex study protocols in Phase I, a trend still relevant today; as we discussed last month, Bracken Data recently noted an uptick in Phase I patient enrollment, which impacts overall trial cost.
In this environment, researchers have cause to be particularly vigilant of the progress of their studies. Problems must be quickly addressed, and delays minimized. One way to achieve these goals is through an EDC software that offers a comprehensive array of study reports. Here are five ways reports provided through an EDC can help keep study timelines down in a particularly time-sensitive era for clinical research.
1. Follow the forms
Clinical trials involve a multitude of forms for both patients and researchers to fill out, each with completion and collection due dates. When a due date is missed, a study can suffer delays – especially when busy researchers with heavy workloads don’t notice that a form is overdue until weeks or even months have passed.
In Medrio, users can run a report allowing them to track the completion status of ePRO forms that have been sent to patients, or generate a list of outstanding user forms, such as adverse event or randomization forms, that show how far past due each one is. Such reports provide researchers with crucial notice when a form has not been completed or collected in time, allowing them to address the matter before it creates costly delays. Without this information, missed due dates can fly under the radar, and study timelines can lag.
2. Are queries resolved quickly enough?
It’s normal for EDC tools to fire queries alerting users to missing or erroneous data. But such queries serve little purpose if the errors they highlight aren’t resolved quickly. How can sponsors and CROs determine if this has been a problem at their sites? Medrio users are able to run reports showing open queries and how long they’ve been open, as well as closed queries and how long it took to close them. These reports can be filtered by site so that sponsors and CROs can determine which sites are resolving queries efficiently, and which are struggling.
This creates an essential analytical capability for researchers, one they can use to better tailor their responses to query resolution delays. And similar reports display the total query rate as a percentage of entered data, allowing researchers to assess whether any change to field, form, or site configuration is necessary in order to keep queries down and stay within their timelines.
3. Keeping track of enrollment
Each day a trial extends past its target completion date can represent major financial losses in the form of trial expenses and missed sales opportunities.1 Researchers can protect against these losses by optimizing the patient recruitment process, which is notorious for being a leading cause of study delays.
EDC reports can be an invaluable tool in this arena. Researchers can use enrollment reports to determine if patient enrollment is below the study target, and to respond accordingly. Medrio’s Weekly Enrollment Report allows users to check progress in short weekly intervals, so that challenges and delays don’t remain unaddressed for too long. And it can be filtered by site, so that new recruitment strategies are only implemented where needed. Sponsors can transition struggling sites to a more social media-centric approach to recruitment, for example, while sites that have stayed on target can continue as is.
4. More efficient variable review
Innovations like eSource and risk-based monitoring are lauded in clinical research today for their ability to reduce the lengthy and costly process of data monitoring. Similar efficiency is possible through EDC reports. When it comes time to review data entered onto a form, Medrio’s Approval Variable Report allows users to view only variables that need to be reviewed, so that they don’t spend time monitoring variables unless it’s necessary to do so.
5. A general overview
Absent incentive to look specifically at query resolution, enrollment progress, or any other particular aspect of a study, EDC users can still run reports to ensure that the study in general is moving along according to its timeline. The dashboard display in a Medrio study consists of high-level data on the study’s progress and is populated by Medrio’s Study Data Summary Report.
As drug development becomes increasingly complicated, it becomes increasingly difficult to rein in timelines and costs in clinical research. EDC reports enable researchers, whether in a high-level overview or a detailed display, to see where delays are originating and thus address those delays in a timely and targeted fashion. These reports are a major component of Medrio’s efforts to facilitate time savings in Phase I and beyond.
1 The Expanding Web of Clinical Trial Patient Recruitment; ISR Reports; March 2014