The solution to [clinical trial delays] ... lies in the adoption of a cloud-based decentralized platform approach. Rather than tether patients to a central, usually urban medical facility, a decentralized clinical trial enables bi-directional communication between study sites and participants.
TYSONS CORNER, Va. (PRWEB) November 22, 2021
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 wakeup call,” says Dr. Harsha Rajasimha, founder and CEO of Jeeva(TM) Informatics. “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 Informatics 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 bi-directional 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.”
About Jeeva Informatics
The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerate therapies for rare and common conditions. He knew that technology in itself is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over 3x faster. The Virginia-based company’s modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device. Visit https://jeevatrials.com/
1. “How to Avoid Costly Clinical Research Delays: Blog.” MESM, mesm.com/blog/tips-to-help-you-avoid-costly-clinical-research-delays/.
2. “Clinical Trials Have Far Too Little Racial and Ethnic Diversity.” Scientific American, 1 Sept. 2018, scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/#:~:text
3. “November Is Pancreatic Cancer Awareness Month.” Hirshberg Foundation for Pancreatic Cancer Research, 22 Oct. 2021, pancreatic.org/november/.
4. “Lack of Diversity in Pancreatic Cancer Trials.” Cure Today, 26 Aug. 2021, curetoday.com/view/lack-of-diversity-in-pancreatic-cancer-trials.
5. U.S. Census Bureau Quickfacts: Vermont. census.gov/quickfacts/VT
6. “Data & Statistics on Sickle Cell Disease.” Centers for Disease Control and Prevention, 16 Dec. 2020, cdc.gov/ncbddd/sicklecell/data.html#:~:text
7. Healthcare, GlobalData. “Disrupted Clinical Trials Due to Slow Recruitment Continue to Rise.” Clinical Trials Arena, clinicaltrialsarena.com/comment/disrupted-clinical-trials-slow-recruitment/.
8. “Data Delays – a Real-Time Challenge for Clinical Trials in Pharma.” Six Degrees Medical, 17 Sept. 2020, sixdegreesmed.com/data-delays-challenge-clinical-trials-pharma/.