As sponsors and CROs feel the pressure to improve clinical trial efficiency, increase enrollment and maintain a solid bottom line, it’s critical that they avoid information overload while measuring the right performance indicators as data from multiple sources is streamlined.
That’s the tall—and growing—order of clinical trial portals, now used by study managers, data managers and medical, safety and regulatory staff to help plan, conduct, manage and review trials.
“The idea of a clinical trials portal has been around, but only now are people understanding the necessity,” said Susan MH Lewenz, CEO of Axxiem Web Solutions, a Hastings-on-Hudson, N.Y. company that provides a secure way to efficiently distribute and track time-sensitive documents and training materials to users around the world.
The company’s AxxiTRIALS global portal—a secure, customizable, private web-based platform—acts as a central point of communications for all members of a trial. It offers a central space for posting patient recruitment metrics and sharing best practices to create a sense of community between investigators, study coordinators and sponsor/CRO project management teams involved in the trial.
For drug developers, Lewenz said, portals save time and resources by distributing documents digitally and dispersing notifications globally, sharply reducing stacks of paper while also enabling global compliance that can include automatic reminders. Comparative enrollment and retention statistics are highlighted to motivate recruitment, along with alerts, notifications and the availability of training materials.
For investigators, the portal engages and motivates them by creating a private online community that can include such social features as a sponsor-monitored blog and forums to enable good multi-level communications.
“A well-designed clinical trials portal accounts for the human psyche in order to motivate users,” Lewenz wrote in a recent blog. “Certainly money can be a good motivator, but it must be used to promote quality results. Being part of a community, part of something that really matters, and being recognized as an individual and a member of an important team—those are very powerful motivators.”
Similarly, other developers of clinical trial portals point to improved communication and collaboration among study sites dispersed geographically, which can reduce errors at individual sites.
“Clinical trial portals are like any other technology—it is wonderful when it is used, but one of the limitations in this industry is that it has been slow to change things and no one wants to change unless 10 others do it first,” said Michael Rosenberg, M.D., CEO and founder of Durham, N.C.-based Health Decisions. The adaptive trials CRO is committed to shortening development timelines and maximizing pipeline value for pharmaceutical, biotech and medical device companies.
Acknowledging that portals are finally catching on, Rosenberg said the major drawbacks are on the data entry side, in which a CRO or sponsor needs one or two staffers to transcribe hand-written materials—a process that can result in errors and interrupt workflow. His company conquers that limitation in several ways, including providing staffers with digital pens that act like cameras and capture key strokes, which they convert to letters and numbers.
For sponsors, the benefit of potentially more information available in one place is currently offset by relatively little information from all the data—a situation that will change as technology improves, Rosenberg said.
For patient volunteers, some portals offer a section in which they can discuss the disease and treatment experience, which can help boost compliance.
At an industry conference last year, Rosenberg estimated about 20% to 30% of CROs and sponsors are using clinical trial portals.
“The need to exchange information and communicate at multiple levels given the time-consuming and complex nature of this [clinical trial multi-step] process, as well as trials becoming multi-center, the need for a system with centralized accessibility at every level, is the need of the hour,” noted Global Industry Analysts in its recent report on Clinical Trial Management Systems.
Already, a wide range of clinical trial technology companies are in various stages of developing and marketing clinical trial portals and dashboards. Much like the gauges and displays in a car or an airplane enable navigation, clinical trial dashboards enable the project manager, along with the data manager, medical monitor and CRA, to view a snapshot of the data relevant to their functions in the clinical trial process.
“Each member of my team has a dashboard with data that relates to their particular role,” said Wendell Guthrie, Chief Operating Officer of Evofem, a small, privately held reproductive and personal healthcare products company for women in La Jolla, Calif. The dashboards were developed using Health Decision’s HD360° Clinical Management platform. “They [team members] no longer have to wait for a report, and then mine the data for their particular needs. The HD system allows them to react and communicate faster and more efficiently because they have the data in minutes, not weeks.”