The cost of patients dropping out of clinical trials continues to be a major problem for the development of new drugs and treatments around the world. Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, is working to boost retention through the use of their patient-centric unified eClinical platform, advanced technology, data, and hyper-personalization, to improve remote accessibility for patients.
MANASSAS, Va. , Nov. 7, 2023 /PRNewswire-PRWeb/ — The dropout rate for clinical trials has long plagued researchers with evidence indicating that sometimes more than 30% of patient dropout during phase 3 clinical trials.(1) A substantial figure, this reality is detrimental not only to the studies themselves but also to the health and wellbeing of all those who may need but will not receive potentially life altering medical help for their conditions. Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, wants clinical trial sponsors and operators to understand what causes these high dropout rates and why it is so important to minimize them. Dr. Rajasimha feels greater remote accessibility for trial participants is key. “We want to make clinical trials universally accessible and more efficient.”
According to a special report from The New England Journal of Medicine,(2) lower participation rates result in incomplete or missing data, which can impact the ability of researchers to draw definitive conclusions or lead to incorrect inferences about the safety or efficacy of a drug. Dr. Rajasimha says the one of the key goals of Sponsors should be to mitigate these risks of patient dropout in clinical trials. “A 30% average dropout rate is not acceptable; over recruiting in anticipation of dropouts is not efficient or innovative. Sponsors need a way to keep the dropout rates under 5%.”
Dr. Rajasimha believes in the potential of human-centric digital technology to play a major role in decreasing the volume of patients who drop out of clinical trials by addressing some of the major impediments in the process, particularly the participation burden placed on the patients. For example, financial strain caused by a study that causes the study member to lose time at work. Often, clinical trials present a time constraint for those involved and this can result in financial strain or time away from the needs of their children or family members. Even traveling to the study location can be a hardship for some participants, if they do not have transportation or if they must rely on friends or family for rides.(3)
While it can be understandable why a participant may not be able to complete a clinical trial, the effect of patient dropouts extend far beyond the individual. The development of new treatments and drugs is involved and expensive, taking on average 10 to 15 years from creation to actual use and costing as much as $2 billion.(4) Enrollment and retention is obviously challenging, as these other statistics reveal:
- 19% of clinical trials were closed or terminated due to failure to recruit enough participants.(5)
- More than half of ongoing clinical trials struggle with patient recruitment. Depending on the type of trial, this number can climb up to 85%.(6)
- 15% to 40% of enrolled participants drop out of their trial prior to completion.(6)
Bottlenecks or delays in this process can result in financial costs or even render the participation of other participants invalid if the study doesn’t mean the data thresholds required by the FDA. Ultimately, lack of participation in clinical trials can mean the trial fails and there are fewer treatments and greater health problems as a result.(7)
A New Age for Clinical Trials
Artificial intelligence or AI offers one way to achieve many of the goals for improving clinical trial retention. AI can help in this area of patient screening and recruitment by analyzing patient population data and identifying characteristics of patients that are most likely to benefit from the proposed drug or intervention. It can also improve the identification and recruitment of patients through electronic health record (EHR) data to match patients to trials.(8) In addition, televisits or video visits in lieu of in-person travel or be away from work can easily begin to lower the burden. Capturing Patient Data using solutions such as remote electronic clinical outcomes assessments (eCOA) including clinician-report, observer-reported, Patient-Reported (ePRO) and (eDiaries) that allow survey participants to report and submit their data remotely and, in many cases, more accurately. In certain studies, such as use of biospecimens already collected for new research projects, informed consenting process can be completed remotely on a live interactive audio/video call.
It is not always about patient dropout; it is also about minimizing missed appointments and ensuring complete and high-quality data capture for all participants by clinical investigator teams. A big part of this is automating certain manual repetitive tasks such as reminders, automatic scheduling, rescheduling, alerts and notifications via SMS or email or audio/video channels. Jeeva’s goal is to improve patient retention by ensuring that trials are more accessible, a critical component of fulfilling their mission to help save lives and improve patient outcomes by accelerating clinical trials and addressing the most pressing problems in the clinical development process. To that end, Jeeva utilizes a unified patient portal platform that offers multiple ways to engage and communicate, from eConsent as a Service, eCoA, ePRO, ClinRO, ObsRO, PerfO, EDC, TeleVisits and VideoVisits, Patient Engagement Portal, and eDiary. TRIALMAGNETTM package was created to achieve the desired stickiness in clinical research.
In addition to patient retention technology, highly responsive study support and timely patient services are critical. This is where Sponsors, can seek to empower the clinical researchers with appropriate technology platform suitable for multi-center studies with flexibility to configure complex protocol designs.
“Ultimately, accessibility is what sponsors, investigators, and patients care about,” explains Dr. Rajasimha, who recently chaired the Indo US Bridging RARE Summit at George Mason University Oct 29 and 30, 2023. The summit included eight sessions including one on Sponsors of clinical trials. “We want to lead this market for sponsors of therapies for rare and chronic diseases to think in terms of how this technology can give accessibility to those that have been historically underrepresented so clinical trials can become universally accessible and effectively engage trial participants. This is aligned with the FDA’s priority and required to satisfy Diversity, Equity, Inclusion, and Access (DEIA) goals appropriate to a disease’s prevalence and epidemiology.”
At the Bridging RARE Summit, Dr. Rajasimha emphasized the need to get global with patient registries for rare diseases and the need to help emerging markets and LMICs to set up their own national registries or natural history studies. “By accelerating the standardized adoption of decentralized clinical trials, Sponsors can achieve efficiency and accessibility for all patients who may seek them. To realize the potential of AI (Artificial Intelligence) in rare diseases clinical research, we need to remove the bias in the data to make it more representative of the general population.” Rajasimha opined.
About Jeeva Informatics Solutions
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 research experience at the NIH and FDA to accelerate therapies for rare and common conditions. He founded Jeeva with the mission of lowering the cost of drug development and accelerating the speed of clinical trials by purpose-building a modern technology platform that empowers sponsors to run clinical trials, with fewer fragmented systems, fewer employees, with significantly less burden on clinical researchers and patients, which has allowed for a more globally diverse population to access clinical trials remotely.
Today the Jeeva eClinical Trial platform supports sponsors and CROs across the globe helping reduce the logistical burdens on patients and study teams by over 70%. Its complete suite of technology supports fully decentralized and hybrid clinical trials and has resulted in being selected by research hospitals, CROs, and sponsors developing pioneering therapeutics such as Frantz Viral Therapeutics and ImmunoACT. The Virginia-based company’s modular cloud-resident software-as-a-service is highly scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials from one login from any browser-enabled mobile device. Visit https://jeevatrials.com/
1) Alexander, Walter. :”The Uphill Path to Successful Clinical Trials”; PT; April 2013; ncbi.nlm.nih.gov/pmc/articles/PMC3684189/.
2) Little, Roderick J., et. al.; “The Prevention and Treatment of Missing Data in Clinical Trials”; The New England Journal of Medicine; October 4, 2012; nejm.org/doi/full/10.1056/nejmsr1203730.
3) “6 reasons patients drop out of clinical trials and 6 ways to fix it”; PMLive, May 12, 2021; pmlive.com/pmhub/clinical_research/couch_integrated_marketing/white_papers_and_resources/6_reasons_patients_drop_out_of_clinical_trials_and_6_ways_to_fix_it.
4) Chaudhari, Nayan, Renju Ravi, Nithya J. Gogtay, and Urmila M. Thatte; “Recruitment and retention of the participants in clinical trials: Challenges and solutions”; Perspectives in Clinical Research; April-June 2020; ncbi.nlm.nih.gov/pmc/articles/PMC7342338/.
5) Grant D. Huang, Jonca Bull, Kelly Johnston McKee, Elizabeth Mahon, Beth Harper, Jamie N. Roberts; “Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative”; Contemporary Clinical Trials; March 2018; sciencedirect.com/science/article/pii/S155171441730753X
6) Ashton, Tiffany; “A Primer on the Importance of Recruitment and Retention in Clinical Trials”; Clinical Researcher; April 18, 2023; acrpnet.org/2023/04/a-primer-on-the-importance-of-recruitment-and-retention-in-clinical-trials/.
7) Fogel, David; “Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review”; Contemp Clin Trials Commun; August 7, 2018; ncbi.nlm.nih.gov/pmc/articles/PMC6092479/.
8) Hu-Rodgers, Tina; “2 Key Areas To Leverage AI/ML For More Successful Clinical Trials”; Clinical Leader; January 3, 2023; clinicalleader.com/doc/key-areas-to-leverage-ai-ml-for-more-successful-clinical-trials-0001.