The FDA has released new guidance for decentralized clinical trials (DCTs) for drugs, biological products, and medical devices to improve DCT implementation. Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, has been a vocal proponent for the increased adoption of decentralized and hybrid clinical trials. DCTs promote diversity among the participant population, create more flexibility and access to boost patient recruitment and retention, and ultimately improve trial outcomes with real-world data from a more representative population. To effectively implement DCTs, the FDA recommends adequate training, proper oversight, and thorough risk assessment and management.
TYSONS CORNER, Va., June 27, 2023 /PRNewswire-PRWeb/ -- As of June 2023, there are 455,756 active clinical trials in all 50 U.S. states and 221 countries worldwide.(1) Unfortunately, studies indicate that the overall success rate of clinical trials is only 7.9%, meaning that, statistically speaking, over 90% of those trials will be unsuccessful.(2) Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, explains, "The exceedingly high failure rate of clinical trials is not necessarily due to the lack of efficacy of the treatment being studied, but it's often the lack of efficacy of the study itself." It appears that the FDA is aligned with this view, given its recent guidance for the industry that encourages it to further modernize its approach to clinical trials to help boost outcomes and lower costs.
One trend in the clinical trial space that is helping to tackle the problem is the evolution of Hybrid and Decentralized Clinical Trials. The FDA has recognized the significant advantages of DCTs and is looking towards broader adoption after their successful implementation during the COVID-19 pandemic. The FDA cites the following benefits of DCTs:
Improving convenience for clinical trial participants.
Alleviating the burden on caregivers.
Expanding access to more diverse populations.
Improving trial efficiencies.
Facilitating research on rare diseases.
Enabling broader participation for populations with limited mobility.(3)
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To these ends, the FDA has recently introduced new guidance to support DCTs in researching the efficacy of investigational drugs, biologics, and medical devices. The new guidance provides recommendations to address the unique challenges for DCTs. There needs to be coordination of all trial activities across multiple locations to address the prevalent issues of design, feasibility, implementation, and analytical considerations to facilitate the decentralization of the trial.
To make clinical trials more accessible, the FDA recommends convenience strategies for participants, such as telehealth visits when physical interaction is not necessary, employing local healthcare personnel (HCP) to perform in-person assessments, and providing HCPs with comprehensive training in following research protocols regarding the proper administration of investigational products (IPs).(4)
To manage DCT operations, the FDA suggests using software that is versatile and can be utilized on various platforms such as tablets, cell phones, and personal computers; it should also be able to handle multiple investigative functions, including:
Managing electronic informed consent.
Capturing and storing reports from remote trial personnel, local HCPs, and remote clinical laboratory facilities.
Managing electronic case report forms (eCRFs).
Scheduling trial visits and other DCT-related activities.
Tracking IPs that are shipped directly to trial participants.
Syncing information recorded by digital health technologies (DHTs).
Serving as communication tools between DCT personnel and trial participants.(4)
Rajasimha notes, "Collecting, tracking, and analyzing data in real-time generates immediately actionable insights and helps to identify opportunities, reduce risk, and make better decisions. With the FDA's continued support and guidance, decentralized and hybrid clinical trials can continue to gain momentum and cement their role in the future of clinical research."
Pharma companies typically spend over $60 million on a large clinical trial.(5) If regulatory bodies deem the gathered data invalid, the loss could devastate the clinical trial and possibly the company altogether. Because the FDA holds biopharmaceutical companies responsible for regulatory compliance via audits, these companies need to make sure they are in compliance at all times with a system that not only complies with regulatory and security requirements but also provides human-centric and flexible real-time monitoring of sites, patients, and their data.
By using platforms that check all regulatory, security, and patient care boxes, like Jeeva eClinical Cloud, biopharmaceutical companies can be fully compliant from the start, saving money, time, and effort.
A human-centric, secure, unified, and flexible platform that is designed specifically for decentralized and hybrid trials and adheres to FDA guidelines and recommendations can accelerate clinical research timelines over 3x faster. This is what Rajasimha and his team have worked tirelessly to deliver to their sponsors and CRO customers since the start of the COVID pandemic.
About Jeeva Informatics The personal experience of losing a child born with a rare congenital disorder and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at the NIH and FDA to accelerate therapies for rare and common conditions. Patient travel requirements and the pandemic forced the demand for decentralizing clinical trials and embracing digital technologies needed to accelerate the process of bringing new medicines or vaccines to patients who need them over three times faster. Jeeva set out to focus on mitigating risks to emerging biopharma clinical trial sponsors as true technology partners, seeking time and cost-efficient ways to execute early-stage clinical trials with minimal risk without compromise. Their reduction of the logistical burdens on patients and study teams by over 70% has resulted in their eClinical platform being selected by a joint venture of Georgetown University Medical Center and Frantz Medical Group for a major cancer trial. 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/.
References 1. Trends, charts, and maps. ClinicalTrials.gov. (n.d.). clinicaltrials.gov/ct2/resources/trends. 2. Kim, E., Yang, J., Park, S.; Shin, K. (2023, May 11). Factors affecting success of New Drug Clinical Trials. Therapeutic innovation; regulatory science. ncbi.nlm.nih.gov/pmc/articles/PMC10173933/. 3. Commissioner, O. of the. (n.d.). FDA takes additional steps to advance decentralized clinical trials. U.S. Food and Drug Administration. fda.gov/news-events/press-announcements/fda-takes-additional-steps-advance-decentralized-clinical-trials#:~:text=%E2%80%9CThe%20FDA%20has%20long%20considered,said%20FDA%20Commissioner%20Robert%20M. 4. Decentralized clinical trials for drugs, biological products, and ... (n.d.-a). fda.gov/media/167696/download. 5. Clinicubes. (2022, September 12). Many stakeholders + different costs = complex clinical trial (part 1). Clinicubes. clinicubes.com/many-stakeholders-different-costs-complex-clinical-trial-part-1/
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