The traditional site-based randomized clinical trial (RCT) process has largely remained unchanged despite the rest of the world innovating in record pace. Established and inefficient practices are simply not meeting the requirements of some sponsor companies especially for trial programs involving digital therapies. Also for smaller, fast moving companies flexibility, cost efficiency and rapid start-up of studies are essential and investing large amounts of money and time into studies are simply not an option. Clinical trial participants have also changed, with high levels of technology adoption across all countries and age groups, the expectations in terms of the availability and quality of digital tools have increased and this puts pressure for sponsor companies to innovate.
This webinar will showcase trial design for a randomized mobile clinical trial to evaluate the efficacy of a digital therapy program for treating depression and anxiety. 100% of the 120 patients enrolled will be smartphone users. The study will be conducted completely remotely, with recruitment through Student Health Service referrals and online advertisement outreach. The study therapy involves a digital therapy app that offers interactions with a remote therapist and an anonymized peer group. Rich patient engagement tools will be utilized through the clinical trial participation and the therapy itself.
The webinar also includes another case study for a remote trial in diabetes which has already been fully completed that incorporated a patient-centric remote trial design, where patients were using a smart wireless glucose meter and digital tools for self-managing compliance. Key performance metrics and patient satisfaction were measured during trial conduct and will be presented in the webinar.
The presentation includes both operational level details and best practices as well as guidance regarding what kind of research projects will most benefit from novel remote research methodologies.
Participants will be able to identify research challenges within their own organizations and how to use modern technology and novel processes to resolve them.
Register today to learn more from remote research experts and pioneering sponsor companies.
Kai Langel
Co-Founder & Director, Patient & Technology Solutions
Since 2000, Kai has been a pioneer in patient-facing systems for clinical trials. Through his involvement in technical, operational and scientific roles, he has gained an in-depth understanding of all aspects of the patient journey in clinical trials from recruitment and engagement through data capture.
He is actively involved in providing guidance to eClinicalHealth’s customers on how to best operationalize new and innovative methods for making it easier and more efficient for sites and patients to participate in clinical trials.
Kristian Ranta
CEO & Co-Founder of Meru Health
Kristian Ranta is a serial entrepreneur and a musician. He is currently CEO & Co-Founder of Meru Health, a ‘digital therapeutics for depression and anxiety’ –startup company.
Previously he was the CEO & Co-Founder of Mendor, a diabetes technology company. Part of Mendor was sold to a Korean public company in 2015. In the fall 2015, Kristian founded Meru Health.
Kristian’s passion is to build global businesses that improve healthcare and how it’s been delivered. He believes in humane values, positivity and the importance of reducing suffering in the world.
Kristian has studied IT at Haage-Helia university of applied sciences and business & leadership at University of Jyväskylä and Aalto University.
- Identify key research challenges that can benefit from remote research methods
- Be able to address key obstacles and considerations regarding remote research models
- Learn best practices that can be applied to any trial
- Be able to identify study protocols that are most suitable for remote research
- Director
- Clinical Operations
- Medical Director Director
- Patient Recruitment & Retention
- Clinical Project Manager
- Clinical Trial Leader
- Clinical Program Director
- Medical Affairs
