Background:
Phase I clinical studies are critical in the development of new therapies especially in the rapidly changing biotech landscape. It became even more prevalent for a life-threatening infectious disease like COVID-19. This case study features a US based biotech sponsor’s successful single country (New Zealand) Phase I COVID-19 study.
The study highlights the sponsor‘s commitment to developing groundbreaking oral antiviral treatments, marking a significant milestone in its mission to deliver critical life-saving therapies. With the successful completion of its Phase I healthy volunteer (HV) study, the sponsor progressed to subsequent stages of clinical development.
Challenge:
The progression from Phase I to Phase II marks a critical stage, necessitating a strategic approach. Conducting Phase I trials presents inherent challenges, especially amidst the complex and precedented landscape of the COVID-19 pandemic. The sponsor effectively navigated these obstacles to ensure a smooth transition.
Action:
To overcome these challenges, the sponsor enlisted the services of Novotech, a global Clinical Research Organization (CRO) known for its extensive experience in managing Phase I studies. Novotech’s familiarity with the ANZ region’s rapid-paced, clinical trial environment, made it the preferred choice. The Company provided strategic insights, regulatory guidance and operational assistance, allowing the sponsor to capitalize on the advantageous regulatory framework and expedited clinical trial processes available in the host country. Novotech also adopted a comprehensive approach in the Phase I healthy volunteer (HV) study, streamlining study start-up and providing a full suite of services. Collaborating with the New Zealand Clinical Research OpCo Ltd (NZCR OPCO) clinical trial facility, Novotech quickly secured approval from the Human Research Ethics Committee (HREC) and initiated site activities. The Company worked closely with the NZCR Principal Investigator, to ensure efficient study monitoring and timely completion. The Data Management and Biostatistics teams contributed to creating a high-quality database, tables, figures and lists (TFLs) that were integrated into the comprehensive Clinical Study Report (CSR) prepared by the CRO’s medical writing team.
Results:
Novotech’s early phase team efficiently activated the site and enrolled 130 participants within six months. The team provided comprehensive services for the Phase I study which was initiated in July 2021 and reached dosing milestone by March 2022. The service offerings spanned clinical trial management, project management, clinical and medical monitoring, regulatory compliance, data management, biostatistical services, and medical writing.
Conclusion:
Novotech's proven expertise, dedication, and comprehensive services facilitated a seamless transition from Phase I to Phase II. The successful Phase I HV trials serve as compelling validation of the strategic partnership approach Novotech employs with its sponsors.