Data management
Many sites use electronic IRB systems to complete and track IRB forms.
As well as enabling the site to gather most of the relevant data in one place, a CTMS can produce reports, showing, for example, progress against milestones, or which patient recruitment strategies were most effective.
Unnecessary duplication
A CTMS does not include all the data necessary for trial management, however. Many sites also use electronic IRB (eIRB) systems to complete and track IRB forms, streamlining workflow. Some may also use an eRegulatory system to store and manage compliance documents. This can lead to unnecessary duplication of information, with data (staff changes, for example, or amendments) having to be entered into both the eIRB and CTMS. As Pennington says: “Study teams have to synthesise information from multiple systems: they have to use their electronic medical record (EMR), their financial systems, their eIRB. They have to pull information from all those systems to do their job.”
“They allow clients or organisations to get a profile of their full portfolio. They can see their protocols, and track the lifecycles of those protocols, in those subjects, through the trial.”
Erin Pennington
Aside from all the documentation relating to the management of the trial (recruitment, scheduling, finance and compliance), there is also the crucial matter of collecting and storing the clinical data, and this is where the industry lags behind. The source clinical data (a patient’s blood pressure, for example) is still recorded on a paper case report
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form (CRF) by the investigator. It is then entered into an electronic data capture (EDC) system via a web portal. The CRF is “the last bastion of paper in clinical research”, says Raymond Nomizu, CEO of startup Clinical Research IO (CRIO). The sponsor or CRO needs to be certain that the data entered in the EDC is accurate, however, so they will send investigators to the research site to check the EDC data against the paper record. This verification process, estimates Nomizu, costs the industry as much as $6bn dollars annually. Clearly, the process is expensive and inefficient. Although electronic CRFs have now replaced paper CRFs in some sites, they have limitations because they do not cover all specifications of the protocol. For example, an investigator can enter a patient’s blood pressure measurements into an eCRF, but the protocol may specify the precise way those measurements are taken (for example, from the same arm, five minutes apart). The data relating to how the measurements were taken is still recorded on paper and has to be verified.
CRIO has developed eSource software – integrated into the company’s CTMS – that enables sites to enter all the clinical trial data directly into easily-tailored templates, without the need for paper recording. “We eliminate the need for sites to re-enter data, eliminate the need for sponsors to confirm that the data matches, and we enable sponsors to have immediate access to the data instead of waiting,” says Nomizu. The software translates the protocol into a series of steps that the investigator has to follow. Unlike paper entry systems, eSource also provides an audit trail. The software has been adopted by 1,000 research sites globally.
Integration is still in its infancy The ability to store and manage trial data digitally only solves half the problem. The range and complexity of information gathered demonstrates how important it is to procure software systems that can share data with each other. As Pennington says: “Standalone systems are not going to help anyone.”
Integrating the CTMS with patients’ EMR, for example, means when a patient enrols in a clinical trial, their information is flagged automatically on their EMR. If the patient is admitted to hospital, that information appears on the CTMS.
In practice, Pennington says, “full integration” is still in its infancy. In some cases, it may simply involve “pushing information from one system to another”. She explains: “What it is not necessarily translating into yet is the ability for the study teams to completely replace their tracking spreadsheets. There is still a lot of reliance on up-to-date spreadsheets, so just to be able to say, ‘OK, this is my schedule for the
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