Lack of Diversity in Lifesaving Clinical Trials Improved by Decentralization
Style Magazine Newswire | 9/22/2021, 12:20 p.m.
Among its many other effects, the outbreak of the COVID-19 pandemic 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)
Historically, clinical trials—administering medication, gathering patient data, etc.—have taken place at a clinical trial site. Emerging technology enables patients to interact with the clinical trial site staff remotely. This helps alleviate a traditional weakness of clinical trials—a lack of diversity among study groups.
Decentralized trials also have the added benefit of saving participants money. While most expenses are covered by the organization sponsoring the trial and study volunteers typically 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.
By making it easier to participate, hybrid or fully decentralized clinical trials help sponsors enroll more patients and reduce the dropout rate.
Many clinical trials 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.
“Decentralization has proven to be highly beneficial to sponsors and patients alike, and to significantly improve patient diversity, recruitment, and retention.” – Dr. Harsha Rajasimha, founder and CEO of Jeeva Informatics
Dr. Rajasimha’s 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.
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 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.” – Dr. Harsha Rajasimha
What are the benefits of decentralizing trials and why is this vital for improving diversity, recruitment, and retention? Dr. Harsha Rajasimha can speak to the following:
What are the downsides of centralized clinical trials?
How have these hindered major medical developments?
How has COVID further hindered this process?
Why is decentralization the answer?
How will decentralization improve recruitment, diversity, and retention?
Why is this is so important?
Who is underrepresented in trials?
How does this affect the quality of new drugs in the market?
How can tech be used to decentralize trials?
How does Jeeva’s technology work?
What companies have they worked with, and how have they helped?