According to Harsha Rajasimha, CEO and founder of Jeeva Informatics, clinical trials often are plagued by significant inefficiencies, which delay the availability of new drugs and treatments. By contrast, up-to-date platform technologies that take a patient-centric approach lead to greater speed, efficiency, and cost-effectiveness.
About 85% of clinical trials centered around new therapies new drugs and medical devices experience delays, Rajasimha pointed out, with more than 90% held back for a month or longer. The financial cost to drug developers can be hundreds of thousands of dollars per day.
“While this is bad news for the pharmaceutical industry, not to mention patients hoping for new treatments, it is also a wake-up call,” Rajasimha said. “Today’s technology and near-universal digital accessibility, offer ways to significantly lessen delays—and possibly costs—in clinical trials.”
On top of delays, Rajasimha, remarked, traditional approaches to trial structure and management tend to hamper patient diversity. Reasons he cited include:
- Trials typically are run in a small number of a limited number of large metropolitan cities.
- Study protocol logistics are less than ideal for the participants concerned with missing work and finding childcare.
- Information about trials is lacking.
Rajasimha added that patient participants tend to be white, with some study populations skewing around 90% white. For example, he stated, while people of color have a statistically greater disposition toward pancreatic cancer, they frequently are underrepresented in clinical trials for oncological treatments.
Sharlene Brown, director of business development for Jeeva Informatics, said underrepresentation can be tied to the narrow pool from which clinical trial teams tend to draw their patients. She related a story of meeting a patient foundation leader who was tasked with explaining to veteran trial operators why a proposed site in Vermont (a state with a population that is more than 94% white) would be less than ideal for recruiting patients for a sickle-cell study (a disease that disproportionately impacts non-white people).
These and other recruitment challenges, Rajasimha said, are one of the most significant contributing factors to trial delays. He pointed to data that shows earlier this year approximately 1,000 organizations involved in medical research announced delays or disruption in their trials, citing either slow enrollment or complex data handling challenges.
Rajasimha said the above problems could be abated by the adoption of a cloud-based decentralized trial approach. According to Rajasimha, this technology enables multidirectional communication between study sites and patient participants.
For example, he said, if empowered by the proper “bring-your-own-device” (BYOD) eClinical platform, anyone with access to a cell phone, or a tablet, or a PC, could use it to interact with the study investigator teams by video, telemedicine, SMS, or email. He pointed out that this approach could enable sponsors to elevate diversity and enrollment, for example, by using social media platforms.
The COVID-19 pandemic has necessitated some of these advancements, Rajasimha said, with restrictions inhibiting the ability to travel to sites.
“Whatever we do, we must not go back but forward,” Rajasimha said. “For the clinical trial process to live up to its own expectations, we must go where the people are, and communicate with them—and they with us—in the most effective way possible.”