Major pharmaceutical companies are beginning to leverage eHealth and cloud technologies in order to improve trial efficiency and reduce costs.
One of the biggest barriers to clinical trial efficiency is the sheer logistical complexity of the process. A clinical study for a new drug typically involves: multiple phases; recruiting, screening and enrolling thousands of patients across the country; ongoing coordination with CROs and investigator sites; results analysis….the list goes on and on.
With so many moving parts involved in the eventual success of a trial, it’s no surprise that roadblocks and delays are increasingly commonplace. And the impact of those delays is tangible: back in 2001, the average cost of securing an FDA approval for a new drug was $802 million — today, that number has surged to a whopping $2.6 billion.
In recent years, experts have been trying to push the industry towards “paperless trials,” which they agree could help reduce these costs significantly. However, the industry has been slow to react: a 2015 Worldwide Clinical Trials survey of more than 1,500 clinical site coordinators found that 67% of respondents preferred paper-based assessments; in a 2016 SCORR Marketing and Applied Clinical Trials survey, 25% of respondents said that 75% of their data collection processes were paperless — while the latter represents a step in the right direction, clearly the industry still has a long way to go.
The Path to Paperless Trials
The primary barrier to widespread adoption seems to a general lack of awareness and understanding of cloud-based technologies. According to Peter Benton, COO of Worldwide Clinical Trials, “There are some concerns about the interference of [a] digital device with the patient-clinician relationship, and the potential impact on the data.” Cliff Echols, Director of Marketing Intelligence at SCORR, explained that in their survey, the “top concerns [with] adopting paperless processes are related to data security.”
But according to Lisa Henderson, Editor-in-Chief at Applied Clinical Trials, this mindset is beginning to shift. She explains that “many respondents, particularly those working within a CRO, believe that there will still be a dramatic increase in their company’s use of paperless processes over the next three years.”
Alistair Macdonald, President of Clinical Development Services at INC Research, agrees that the industry’s perception of digital is beginning to shift:
“People have realized they don’t need everything inside their company firewall,” he says. “In the past, we had servers for everything, and people used to worry about service levels and how quickly they could recover from data loss. The cloud has proven to be very robust. It’s proven itself over the last five to ten years and the world of data communications and storage is very robust compared with what was expected.”
A Cloud-Centric Future
While we still may be a ways off from universal adoption, there are a number of major players that have already made the switch to digital. Pharmaceutical giant Pfizer recently announced it will be leveraging cloud-based technologies to “manage and monitor every aspect of [the] process, from trial creation to data collection, cleansing, and submission.”
Bioclinica has partnered with Parallel 6, a patient-centric mobile clinical trial platform, which will be integrated into the Bioclinica eHealth Cloud. Similarly, Sanofi recently helped clinical trial technology company Science 37 raise $31 million in series B funding. Science 37’s platform, NORA (Network Orient Research Assistant), allows sponsors to leverage what it calls “metasites,” thereby enabling patients to participate in trials from the comfort of their homes (and under the supervision of their existing doctors).
When it comes to improving trial outcomes, the importance of efficient recruitment and retention, data collection and analysis, trial site monitoring, and the like cannot be understated — and the cloud represents an opportunity to check every single one of these boxes. Sponsors, CROs, and site coordinators need to recognize the benefits of these emerging technologies and adjust their practices accordingly — or risk perpetuating the cycle of skyrocketing costs we’ve been trapped in for the last half-century.