Over the last two years, testing of new drugs, medical devices, and vaccines has increasingly been done outside large medical centers. To benefit both sponsors and patients, Dr. Harsha Rajasimha of Jeeva Trials, urges further decentralization of the clinical trial process.
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Among its many other effects, the outbreak of the COVID-19 pandemic in early 2020 seriously disrupted new drug testing, treatments, and in-person healthcare services. As medical centers were forced to focus on COVID-related care, and optional travel was curtailed by the need for physical distancing, patients’ access to clinical trial sites was reduced by some 80%.(1) In response, notes Dr. Harsha Rajasimha, founder and CEO of Jeeva Trials, sponsors have moved rapidly to shift as much clinical trial activity as possible from centralized locations to the patients’ homes or nearby facilities such as pharmacies—with positive results. “Decentralization,” says Dr. Rajasimha, “has proven to be highly beneficial to sponsors and patients alike, and to significantly improve patient diversity, recruitment, and retention.”
Role of new technology
Historically, clinical trials—administering medication, gathering patient data, etc.—have taken place at a clinical trial site. To a great extent, this is no longer necessary. Today’s technology enables patients to interact with the clinical trial site staff remotely. This, notes Dr. Rajasimha, helps alleviate a traditional weakness of clinical trials—a lack of diversity among study groups. Studies have shown that participation in clinical trials for new drugs has tended to skew heavily white—in some cases, 80 to 90 percent.(2)
In addition, by making it easier to participate, hybrid or fully decentralized clinical trials help sponsors enroll more patients and reduce the dropout rate. They can also save participants money. Although most expenses are covered by the organization sponsoring the trial and study volunteers receive a nominal stipend for participating, paid time off and other indirect expenses may not be covered. By eliminating the financial burdens associated with time and travel, at-home participation has emerged as a more attractive option.
Many clinical trials, notes Dr. Rajasimha, are best suited for a hybrid approach. For instance, evidence generation could alternate between patients’ responding to a standard questionnaire for assessment and clinicians making outcomes assessments of individual patients. By the same token, patients could report their outcomes remotely and drop off their samples either in person or have a phlebotomist collect the sample at their home or another remote location.
Long-range nutrition study
Other options are possible. Dr. Rajasimha states that his company is working with a major U.S. university on a hybrid decentralized study of the impact of food and nutrition on the academic performance of college students. The study will enroll an eventual total of 2,500 students and follow each student for a period of five years. Except for a one-time visit to the university’s clinic, participants are responsible for generating all the study’s data: a monthly survey, a twice-yearly assessment questionnaire, and a daily record of nutrition intake. Jeeva Trials’ will enable participants to complete all three of these reports through a single mobile app.
Looking ahead, ensuring continuity and integrity of clinical trials during and beyond the pandemic, without compromising patient safety is of paramount concern for all stakeholders. Dr. Rajasimha projects that in one year, 30% to 50% of all clinical trials will be either fully decentralized or hybrids. By enabling participation for diverse sample populations and by improving participant retention, this will bring benefits not only to sponsors and participants, but to the patients as well.
“In developing software for this sector,” says Dr. Rajasimha, “we seek to address patient recruitment, patient retention, and quality of real-time evidence generation, while adhering to a multiplicity of national and international regulatory guidelines. We strongly believe that this work—as it stands now, and as it develops—will make life easier for all concerned stakeholders and will make a meaningful contribution to the goals for which the clinical testing is intended.”
About Jeeva Clinical Trials Inc.
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 accelerating 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. “No Place like Home? Stepping up the Decentralization of Clinical Trials.” McKinsey & Company, McKinsey & Company, 11 June 2021, mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/noplace-like-home-stepping-up-the-decentralization-of-clinical-trials.
2. “Clinical Trials Have Far Too Little Racial and Ethnic Diversity,” Scientific American, September I, 2018, scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/
