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 Informatics, urges further decentralization of the clinical trial process.
(Tysons Corner, VA) August 30, 2021—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 Informatics, 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 the majority of subjects 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 Informatics’ will enable participants to complete all three of these reports through a single mobile app.
Looking ahead, 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 Informatics
Jeeva Informatics Solutions, Inc., based out of Tysons Corner, VA, partners with Biopharmaceutical or medical device sponsors, CROs, and clinical researchers to accelerate clinical studies. The Jeeva™ TRIALMAGNET TM package of the patent pending Jeeva™ eClinical Cloud platform achieves remote patient recruitment goals by as much as three times faster. Jeeva’s flexible bring your own device (BYOD) SaaS solution works on any browser-enabled mobile device and accelerates research by 3X while minimizing more than 70% of the logistical burdens on study teams and patients. Modular software design allows a rapid study configuration with the features and workflows that fit the specific trial protocol whether short-term or long-term, cross-sectional or longitudinal, interventional or observational studies, clinical phase or post-market, hybrid or fully remote.
To learn more, visit jeevatrials.com.
- “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.
- “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/
Karla Jo Helms