The last time the Women’s Health Initiative (WHI) conducted clinical trials, in the late 1990s and early 2000s, researchers didn’t trust the Internet to transfer patient information. They communicated by phone, fax or mail.
But clinical trial management has changed dramatically since the first patient records were digitized. Today, WHI studies have no choice but to use the Web for patient, medical record and administrative data transfers, said Lisa Johnson, a project manager and trial coordinator.
“The workload forced us to look for better solutions for cross-agency communication,” Johnson said.
Because of its elderly patients, the WHI studies may be slower than most to fully access 21st century technology. But elsewhere, a growing number of clinical trials are using highly integrated global systems with advanced electronic capabilities for managing inventory and data collection. And that’s crucial for improving coordination of patient care, increasing efficiency of clinical trials and reducing study costs at a time when bringing a new drug to market can run well over $2 billion.
The challenge remains that clinical trials are growing in complexity with unexpected delays, waning enrollment and underperforming sites. Some trials face demanding timelines, recruitment setbacks, budget cuts and mid-study drug recalls.
Some of the latest trends in clinical trial management provide solutions to the mounting complexity and costs:
According to a 2015 market research report, by 2020, close to 72 percent of clinical trials will be managed by a professional contract research organization (CRO).
These, and other biopharmaceutical service providers, help improve integration of multiple interactive systems that a clinical trial uses to gather and analyze data, said Gary White, director of strategic provider alliances for Quintiles, the world’s largest provider of product development and integrated healthcare services.
Consolidation provides researchers, trial managers and other end users with a single access point from which to gain a “comprehensive view of data,” helping users make more informed clinical decisions faster, White said.
Those decisions may be based on intelligence from such technology as Electronic Data Capture (EDC), Electronic Patient Reporting Outcomes (ePRO) and any Clinical Trial Management System (CTMS), said Grant Dietrich, director of account management for Cenduit, which provides clinical trial consulting and custom IRT (Interactive Response Technology) solutions.
IRT is also known as IWRS (Interactive Web Response System) or IVRS (Interactive Voice Response System). During a trial, IRT may keep track of inventory, ensure drug randomization, handle orders, and control the delivery of supplies to the testing site as needed, Dietrich said.
“Patients have many tools to help them manage their own care,” said David Stein, an independent eClinical consultant. Through online communities and social media, patients may find trials, be screened and enrolled online, and receive reminders about upcoming visits or the need to complete diaries, assessments or fast before certain lab procedures. They may also receive motivational messages from their healthcare professionals, he said.
Keeping in touch with the patient in this manner improves retention and compliance, Stein said. These are two key areas, considering the loss of time and money when patients drop out of a trial or don’t comply with protocol, he said.
Patient dropout rates can be more than 30 percent in phase 3 clinical trials, the National Academies Press reported several years ago. Also alarming, 11 percent of clinical trial sites fail to enroll a single patient, according to Tufts University.
Using automated systems such as IRT to manage and monitor clinical supply inventory improves patient retention and compliance too. It ensures investigator sites have the required materials available for each patient visit and helps reduce the number of patient events that have to be cancelled, White said.
Mobile digital technology
“Mobile technology is a critical component of digital management and represents a huge leap forward in running a good clinical trial,” said Dr. David Scher, a cardiologist and digital health technology consultant.
Consider a pill with a biodegradable sensor that sends a digital message to the study coordinator and caregiver documenting the patient’s vital signs and precise medication adherence. There’s also a clinical trial mobile app that alerts the study coordinator if a patient ends up in a medical facility, without having to wait for the patient to report it.
If there’s a planned or surprise audit, or a regulatory agency wants to view the data, it’s available in “real time,” said Scher, a seasoned clinical investigator for such clients as the National Institutes of Health. “In the old days one might have had to scramble for the charts and/or data.”
Effective clinical trial management integrates multiple technologies and software solutions so they “come together seamlessly under the same technology roof or platform,” Scher said.
“Streamlined access is very important,” Dietrich said. When the clinical staff has to access multiple URLs or complete additional steps such as downloading, it distracts from patient care, Dietrich said.
Considering how global and complex trials have become, “it requires orchestration of all the data elements that support a clinical trial.”