In Search of the Holy Grail - Pharmaceutical Executive


In Search of the Holy Grail
Chasing ultimate clinical trial efficiency, one small step at a time

Pharmaceutical Executive

Of course, no one could anticipate every problematic scenario. The benefits of sharing screening-log data came with an unexpected downside. Like most drug companies, P&GP is increasingly focused on timely patient recruitment for clinical studies. In particular, investigators became interested in why patients fail screening. When analyzing screening patterns, we found that data-entry mistakes were relatively common. In some cases, a screening failure was inadvertently enrolled in the study. In others, a volunteer who met the inclusion and exclusion criteria and who had signed informed consent was excluded in error. By the time the error was discovered, the EDC system contained incorrect patient details and the patient either randomized or excluded. As a result, either the patient needed to be rescreened, or the misattributions had to be reconciled.

Often, this problem emerged only after the investigator called to randomize the patient using IVR. When a patient is mistakenly screen failed, he or she is not visible in the EDC system, and site personnel cannot enter further clinical data for that patient. As a result, the investigator calls the help desk. From the perspective of the help desk personnel, a patient might fail to appear in the system for several reasons. But nine times in 10, the error arises through data entry. Typically, it takes a member of the help desk staff half a day to identify the cause of the problem, and the rest of the day to fix it. In a study that enrolls four hundred or five hundred patients, such problems may occur, in P&GP's experience, 10 or 15 times. Although the true cost of this additional effort has not been calculated, it is safe to assume that the increased help desk, data cleaning, and monitoring efforts result in significant costs. However, with a few minor adjustments to the integration workflow, such issues can be overcome.

Ironically, one of the IT system's great strengths—real-time updating—contributed to this problem. Investigators invariably are impressed when they use IVR to enroll a patient and, in just a few minutes, look at the eCRF and find the case report form ready. Real-time updating is also impressive when demonstrated to the end-users at the sites. However, P&GP managers are beginning to question whether updating ought to be so rapid. Typically the information is available throughout the integrated system within five minutes of entry into one interface (for instance, the eCRF or IVR). It may turn out that a slower turn around, perhaps batch processing each night, would give investigators the opportunity to catch these mistakes while still allowing timely decision making. On the other hand, lengthening the turnaround time might impede the workflow at the site, especially since investigator time is at premium.

Managers implementing data integration must consider the needs of internal and external stakeholders—patients, investigators, the medical department and the clinical research associates (CRAs)—as well as the technical issues. In general, internal and external stakeholders readily accept data integration. In-house, for example, the integrated network allows the medical department and CRAs to stratify the data; for example, they can analyze the clinical study cohort according to various demographic or inclusion criteria.

Dealing with Pressing Problems Bidirectional data integration of CTMS and EDC may eventually encourage investigators to participate in clinical studies, particularly those motivated by financial considerations. Investigators understandably want to be paid for their research promptly. At the same time, sponsors want to receive clean data as quickly as possible. This means that sites must not only enter data promptly, but also must respond to queries in a timely manner. Now if CTMS is being used to generate investigator payments based on certain milestones, a logical step might be to transmit metrics on clean case books from the EDC system to the CTMS so that sites can be paid for clean, final data.

Further integrations with CTMS could involve investigative site addresses, which are already entered and maintained in several systems. If CTMS represents the definitive source for up-to-date site information, then other clinical systems could access necessary names and addresses from this source. Re-entering such information is inefficient and a great time-waster. For example, if an IVR system automates medication resupply to each site, why not allow CTMS to send current address information to the IVR rather than requiring a study-team member to look up and rekey the address? The bidirectional data flow also could ensure that study materials are shipped to study sites in the timeliest manner. For example, if CTMS tracks institutional review board (IRB) approval of a site, that, in turn, could signal the IVR system to ship the initial drug supply to that site.


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