Decentralized Clinical Trial Support for non-COVID Clinical Trials during COVID-19 Pandemic

According to GlobalData, 67.3% trial disruption during COVID-19 pandemic in 2020 was due to suspension of patient enrollment, while 18.4% was due to delayed trial initiation. 14.4% of trial disruption was due to slow patient enrollment.

The adoption of Decentralized Clinical Trials (DCTs) helped pave the way for patient centric measures, enabling Navitas Life Sciences to conduct clinical trials through the pandemic. Between 2014 to 2019, drug-based interventional DCTs exhibited a 7% CAGR while it grew to 77% between the latter half of 2019 and in 2020, during the COVID-19 pandemic.

DCTs leverage the use of emerging technology and telemedicine to ensure better patient participation. There are several advantages that are provided by DCTs when compared with traditional methods.

Patient Benefits in Decentralized Clinical Trials

Higher Patient Recruitment

Improved access to patients, lower travel needs and at home visits ensure better patient enrollment

Better Patient Retention

Reduced need for site visits, and better patent engagement ensures better patient retention

Improved Patient Convenience

Patients can participate in trials from the comfort of their homes

Increased Patient Access

Patient with rare disease conditions, those separated by great geographical distances, and more can participate

Decentralized monitoring Model

Decentralized monitoring model allows remote monitoring of activities, which will help in better comfort for patients and faster completion of the trial.

Benefits of Decentralized Trial Monitoring

• Faster initiation of trials
• Faster and better quality of data collection
• Better trial oversight using artificial intelligence

Decentralized Clinical Trials at Navitas Life Sciences

Navitas Life Sciences invested in digital tools, Artificial intelligence (AI) and Machine Learning (ML) tools over the past few years. These tools were leveraged to ensure clinical trial continuity during the pandemic.

According to ClinicalTrials.gov, there was a steep reduction in the number of new clinical trials that were started between January 2020 and May 2020. Michael Lauer from the US National Institutes of Health had stated that nearly 80% of non-COVID trials were either stopped or interrupted due to pandemic mediated restrictions.

Highlights of 3 Important clinical trials supported during the COVID-19 pandemic:

1) Oncology Clinical Trials: Navitas Life Sciences continued to support a client’s oncology trials, to help bring lifesaving drugs to the market sooner. The unprecedented COVID-19 pandemic posed new challenges for ongoing and new trials. This included ensuring safety of enrolled patients, supporting new patient recruitment, and reducing patient dropout and non-compliance due to travel restrictions and quarantined areas.

The pandemic increased the risk of not completing patient recruitment with a likely disruption of the supply chain, and inaccessibility of sites resulting in an inability to follow up with patients. This threatened to affect trial timelines, data monitoring and the budget. The COVID-19 pandemic has brought to the fore the need to build adaptive systems that help in transcending evolving environments. Navitas Life Sciences has been investing in developing remote data monitoring and technological advancements which helped in seamless collection of necessary data.

Highlights of the support for new and ongoing oncology clinical trials

• Limited in-person visits for safety checkups and primary endpoint assessments. Use of telemedicine for non-complex procedures such as laboratory check-ups
• Use of digital and online platforms for improved engagement with participants and to obtain responses to questionnaires
• Alternate transportation organized for home-site and site-home travels to avoid mass public transportation
• Protocol designed to suit the needs of the patient
• Data-driven strategy to maximize recruitment potential

2) Vaccine trials for Centers for Disease Control and Prevention (CDC): High quality and efficient clinical studies conducted by Navitas Clinical Research, a part of Navitas Life Sciences, as the US Centers for Disease Control and Prevention partner for vaccine trials every year. The study involves implementing anonymous Pre and Post Influenza Vaccine Sera Panels with the current, seasonal, quadrivalent, killed virus influenza vaccine. The study was conducted on population ranging from the pediatric population to the elderly.

Highlights of Support for Vaccine Trials for CDC

• Adhering to all deadlines
• Delivering under budget
• Managing patient recruitment, including pediatric population

3) National Institute of Health(NIH) Studies on Arthritis and back pain: The NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) requires clinical study management and scientific infrastructure support studies on low back pain, osteoarthritis, rheumatoid arthritis, skin diseases and other disabling disorders.

Highlights of Support for NIH studies

• Early Detection and Resolution of Risks
• Efficient utilization of research funds
• Highly trained investigators
• Better quality of studies

The support involves in person and remote study and site assessments to evaluate the readiness of a project team to initiate patient accrual, the study operations, and/or study closeout summarized in timely reports.

Navitas Life Sciences has conducted multiple clinical trials across multiple therapeutic areas, efficiently utilizing solutions that were developed over years of research on technological advancements.

Navitas Life Sciences has been quick to identify potential clinical trial disruptions and to resolve them successfully by intelligent use of resources. A culture of resilience has also helped in overcoming challenges while expert insights have helped in reimagining clinical trial efficiency.

To learn more about our oncology clinical trial, support, read our latest case study here.