Data is king

Sites that conduct clinical research trials have to manage multiple relationships, including those with patients, the patients’ health care providers, suppliers, the regulator, the Institutional Review Board (IRB) and the sponsor. Patient details, including communications, need to be stored, appointments need to be scheduled, tasks for staff have to be allocated, protocols need to be managed, interactions with the IRB must be tracked and all billable work accurately noted. Finally, of course, the clinical trial data itself has to be captured.

Accurate, consistent and accessible

Given this complexity, it can be hard to make sure that data is accurate, consistent and easy to access. Traditionally, sites have used multiple spreadsheets to keep track of data, but as well as being unwieldy to use, they can lead to information being out-ofdate, inconsistent, or inaccurate. In the past decade, however, sites have begun replacing spreadsheets with systems that help them manage trial data more effectively and efficiently.

The most significant development is the clinical trial management system (CTMS) – cloud-based software that enables a research site to store information relating to the running of the study (in particular, recruiting patients, scheduling and financial management) in one place, creating a single version of the truth and avoiding duplication and inconsistencies.

“They allow clients or organisations to get a profile of their full portfolio,” says Erin Pennington, director at Huron Consulting Group. “They can see their protocols, and track the lifecycles of those protocols, in those subjects, through the trial.”

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.”

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 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 day, can I integrate it with Outlook, can I get this to the lab so they know exactly what tubes to draw?’ All those little day-to-day co-ordination things the study teams have to manage – I think we have got room for growth there.”

The challenge, says Pennington, is that a single element of the CTMS needs to integrate with multiple other systems. “Usually there’s one representation of the protocol calendar in the system – that’s pretty standard in all the systems I’m familiar with,” she says. “But that one calendar has to drive the protocol schedule of the study co-ordinator perspective. It has to drive integration to the medical records system for compliant billing, at least in the States, and then it has to drive sponsor billing activities. So in order to fit the protocol schedule into the system, there are some suboptimal practices that happen, to make it work for one audience or another.”

Main ROI is recovering revenue

Pennington’s company, Huron, makes sure that its IRB software integrates with OnCore, the leading CTMS, and with eRegulatory systems: “That’s providing a lot of value, particularly in terms of getting consent forms to the people who need them at the point of consent.” As soon as a new consent form is approved, it can be shared with a staff member in the clinic who can put it in front of the patient for signing.

But, she adds, the main return on investment for a CTMS will come from recovering revenue for the clinical trial: “Part of that is making sure you’re optimising the way you’re doing your financials in your CTMS so that you’re able to recover all those components of the trial that you spend all that time budgeting for.” Thought needs to be given to how those activities are tracked on the study so that the sponsor is billed for them.

Another key feature to look for when purchasing a CTMS, says Pennington, is reporting: “You’re going to want to get data out of these systems for your users. Make sure that reports you’re seeing in demos actually meet the needs the users have. Asking people to spend a lot of time putting things into the system where they don’t get anything out is a recipe for them not using it.”

A solid migration strategy is essential

A CTMS is a “significant investment,” Pennington points out, and before purchasing, organisations should make sure that they have “appropriate staffing, and that they have a solid, realistic timeline and project plan”. They need to approach data migration carefully: “If the data is bad or there aren’t solid migration strategies, you can create a lot of havoc by migrating.”

Even a high-quality CTMS, however, will only demonstrate value if implemented in a way that ensures staff engage with it. “The challenge with any system is getting everyone to use the system in a way that makes the data meaningful at the end of the day,” says Pennington. “There are plenty of people who have made significant investment in CTMS but either because they fail to mandate use within their organisation, or [fail to] put any policies in place to make sure people were using the system, or neglected change management components of their implementation, they end up with a system that doesn’t have reliable data.”

While a CTMS can be a “really good investment for an organisation,” Pennington adds, like all computer systems, it can “help you do dumb things faster. So one piece of CTMS implementation advice is to take the time to think through your workflows before you implement. It’s a really good opportunity to improve what you’re doing and not just automate what you’re doing”.