Source: PubsOnline
Over the past two years, the testing of new medical devices, drugs and vaccines has increasingly been performed outside large medical centers. Faster enrollment, fewer dropouts and global diversification of trial participants are some of the ways the clinical trial industry has been disrupted during that time frame.
U.S. Food and Drug Administration (FDA) data shows that African Americans account for more than 13% of the total U.S. population, yet they constitute only 5% of those who take part in clinical trials. Addressing this racial inequality is an important concern for clinical researchers.
The diversification of clinical trials is important because every individual could respond to the same drug, medication or vaccine in a different way. Reactions may depend on individual traits such as body mass, metabolism or genetics. About 85% of clinical trials are delayed because of slow enrollment, and about 30% of trials terminate early due to poor enrollment. Once enrolled, about 30% of trial participants drop out during the trial duration. These issues cost the life science industry more than $50 billion in losses and cause years-long delays for patients to gain access to potential lifesaving therapies.
Studies show that many people who are part of ethnic or racial minority groups don’t trust healthcare systems or medical research communities. Mistrust is deeply rooted in the medical system. Members of minority communities often don’t participate in trials owing to financial burdens, logistical challenges and lingering distrust from past victimization in medical experiments.
The lack of diversity is not limited to African Americans; many clinical trials lack participation from other minority communities. Studies show that many benefits arise from having higher rates of enrollment by minority participants in medical/clinical trials, so what can be done to increase minority participation?
One way to increase minority enrollment could be through government regulations. Another option involves biopharmaceutical companies dedicating resources to encourage and educate minority patients.
In addition to having young patients in my own family with a rare disease and a chronic condition, these industry challenges inspired me to develop a human-centric eClinical platform.
Diversified Populations, Trial Challenges
Enrolling diverse populations in clinical trials is necessary for proper research and to ensure that the particular drug or medical therapy is effective for everyone it is intended to help. Clinical trial participation has largely been restricted to patients living within a 50-mile radius of brick-and-mortar trial sites – until the COVID-19 pandemic hit and most clinical trials had to be put on hold indefinitely. The pandemic has made it necessary for clinical trials to be decentralized to ensure continuity and integrity for on-site or virtual trial designs. Not having decentralized trials leaves many people living too far away from the trial sites without access to therapies that are in clinical trial phases and would answer unmet healthcare needs.
Decentralization is proving to be highly beneficial to sponsors, sites and patients alike and can significantly improve patient recruitment, retention and diversification. Discovery interviews with more than 2,000 clinical research stakeholders revealed various operational and logistical issues influencing the choice of decentralization. Piecemeal solutions and a la carte tools have added to the burden of training, validation and compliance. Platform technologies are needed to consider all perspectives from a deep understanding of the patient journey, regulatory environment and R&D process.
The Role of Innovative Technology
Historically, clinical trials involve administering medications, gathering patient records, etc., which have to be obtained at the trial site. Because of the pandemic, this is no longer the preferred way, as demand for digital technology increased to enable patients to safely interact with clinical trial site staff.
Low patient recruitment is also a logistical problem, such as travel logistics, financial burdens, data management and patient education. The Jeeva eClinical platform, when deployed responsibly, can increase opportunities for socioeconomically disadvantaged and geographically diverse patients to participate in clinical trials independent of their ZIP code. A single login enables maximum flexibility for remote or in-person completion of various tasks in a clinical trial, such as remote patient screening, education, informed consent, patient-reported outcomes, clinical assessments, follow-up visits via telemedicine or video calling, bidirectional communications between site staff and patients via audio/video/SMS/email and adverse-event reporting. These can minimize the burden of the on-site staff and maximize engagement and retention.
The Next Stride in Clinical Trial Solutions
Thanks to the emergence of new and improved technologies and access to real-time clinical data, there will be an increase in the efficiency and effectiveness of clinical trials in the future. This will also increase the clinical trial industry’s capacity to innovate. We have identified the following key ideas that organizers should know regarding the innovation of new technologies:
- Following the flexible trial design to decrease overall clinical trial timelines.
- Stay-at-home trials from any browser-enabled mobile device without need for any specialized hardware.
- Real-time seamless data management.
- Harnessing the power of continuous streaming patient data from wearable devices.
- Data transparency and ownership.
The accessibility of new technology will have an immense impact on everyone involved in the clinical trial process – 82% of Americans and 60% of people globally have regular access to the internet. Online eClinical technology will give more patients from diverse populations access to more lifesaving therapies during the clinical trial process.
Jeeva’s solutions to clinical trials can be very convenient for a large number of people using the internet. The technology platform developed by Jeeva is simple for clinical staff and patients to operate, and the technological advancements will transform future clinical trials in many ways – from manual processes such as printing, faxing or cataloging paperwork to automated and innovative processes within a digital environment.
These process changes will result in long-lasting improvements, including reduced costs, faster study timelines, stronger regulatory compliance, diversification of trials and safer clinical trials.
Harsha Rajasimha
Harsha Rajasimha, Ph.D., is founder and CEO of Jeeva Clinical Trials Inc. (www.jeevatrials.com), based in Virginia. He is a precision medicine data scientist turned social entrepreneur on a mission to accelerate human-centric clinical research through technology innovation and global advocacy.
