Source: HR.com
Serious inefficiencies are hampering clinical trials of new drugs and treatments, prolonging the suffering of millions. Today’s platform technologies, says Dr. Harsha Rajasimha of Jeeva Trials, enables more flexible trials that are faster, more efficient, and more cost effective than traditional approaches.
TYSONS CORNER, Va., Nov. 22, 2021 /PRNewswire-PRWeb/ — A recent study shows that about 85 percent of clinical trials of new drugs and medical devices will experience delays, and over 90 percent of them for a month or longer. The cost of these delays to the developer run between approximately $600,000 and $8 million per day.(1) “While this is bad news for the pharmaceutical industry, not to mention patients hoping for new treatments, it is also a wake-up call,” says Dr. Harsha Rajasimha, founder and CEO of Jeeva(TM) Trials. “Today’s technology and near-universal digital accessibility, offer ways to significantly lessen delays—and possibly costs—in clinical trials.”
In addition to delays, says Dr. Rajasimha, the traditional approach to clinical trial structure and management tends to discourage patient diversity. Chief among the many reasons for this is the fact that trials are held in a limited number of large metropolitan cities, study protocol logistics are suboptimal for the participants concerned with missing work and finding childcare, and because of a lack of information. Patients who participate in these studies skew heavily white—in some cases, 80 to 90 percent.(2) Noting that November is Pancreatic Cancer and Lung Cancer Awareness Month(3), he points out that though people of color have a statistically greater disposition toward pancreatic cancer, they are under-represented in clinical trials for treatments of this life-threatening disease.(4)
This sort of under-representation, says Dr. Sharlene Brown, Jeeva Trials Director of Business Development, can be traced to the narrow pool from which clinical trial participants tend to be drawn. In one case, she recalls encountering a patient foundation leader charged with explaining to veteran trial operators why a proposed site in Vermont—a state in which white people make up 94.2% of the population(5)—would be less successful at recruiting local participants living with sickle cell disease—a disease that in the U.S. most commonly affects people of color.(6) In a broader sense, adds Dr. Rajasimha, recruitment problems are a leading cause of delays in clinical trials. Earlier this year, approximately 1,000 organizations involved in medical research announced delays or disruption in planned clinical trials, the bulk of them caused either by slow enrollment(7) or complex data handling issues(8).
The solution to these problems, he suggests, and with it the potential for reduced delays and greater study effectiveness, lies in the adoption of a cloud-based decentralized clinical trial platform approach. Rather than tether prospective patients to a central, usually urban medical facility, a decentralized clinical trial enables bidirectional communication between study sites and participants, primarily through the Internet. If empowered by the right bring-your-own-device (BYOD) eClinical platform, anyone with access to a cell phone, or a tablet, or a PC, can use it to interact with the study investigator teams by video, telemedicine, SMS, or email. Among other benefits, says Dr. Rajasimha, this approach enables sponsors to increase both diversity and enrollment by recruiting through social media platforms.
Some of these needed changes in clinical trials, notes Dr. Rajasimha, have been accelerated by the COVID-19 pandemic, which has made many prospective enrollees unable or unwilling to travel to a hospital or other major medical facility, to participate in a new drug study. At the same time, the pandemic has strained the ability of hospitals to deal with swelling crowds of severely ill patients, let alone simultaneously administering a non-COVID19 clinical trial. In response, many trial sponsors have begun adopting a decentralized structure out of necessity.
Dr. Rajasimha hopes that this trend will continue. “Whatever we do,” he says, “we must not go back but forward.” Across the board, decentralizing clinical studies is an important part of the solution for delayed and under-enrolled clinical trials. Medical research is, he notes, in the end about patients—about people. “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.”
