Indian Biotech Phase IIB

Background

A biotech company based in India embarked on a Phase IIb clinical trial to evaluate a novel treatment for Locally Advanced or Metastatic Breast Cancer. The sponsor chose to conduct the study in Georgia due to the country’s supportive regulatory environment, favorable trial conditions, and rapid approval timelines. The trial involved 40 patients across three sites and ran from September 2021 to March 2023.

The sponsor sought Novotech’s expertise in navigating the complexities of patient recruitment and managing multi-site clinical trials within accelerated timelines.

Scope of Study

Novotech’s scope of services for this project included:

• Principal Investigator (PI) and site liaison.
• Clinical trial supply management.
• Patient recruitment in alignment with complex inclusion/exclusion criteria.
• Comprehensive project management.

Challenge

The sponsor needed to recruit 40 patients for this complex Phase IIb study rapidly, and within the regulatory guidelines for Georgia. The trial had challenging inclusion and exclusion criteria that required strict adherence to ensure data quality, along with a timeline requirement for rapid recruitment.

The primary goal was to conduct the trial within Georgia's favorable regulatory environment, which required a partner with in-depth knowledge of the region and the ability to fast-track trial approvals and site initiations.

Why the sponsor Chose Novotech

The sponsor selected Novotech for this pivotal study due to several key factors:

• Extensive Study Experience: Novotech’s proven track record in managing oncology studies was critical to the sponsor’s decision.
• Therapeutic Expertise: Novotech’s experience in oncology trials allowed the team to develop precise strategies for patient recruitment and trial execution, overcoming inclusion/exclusion and timeline challenges.
• Local Expertise in Georgia: Novotech’s established relationships with PIs, site managers, and regulatory bodies in Georgia enabled swift regulatory and ethics approvals, expediting trial initiation and start-up activities.

Action

To meet the sponsor's objectives, Novotech employed a comprehensive strategy that focused on:

• Regulatory and Ethics Approvals: Novotech worked closely with local regulatory bodies to secure approvals within the projected timelines, allowing the trial to begin on schedule.
• Site Activation: Novotech leveraged strong relationships with PIs and clinical sites, ensuring rapid site initiation and start-up activities across all three trial locations.
• Patient Recruitment: Novotech developed a tailored recruitment plan, enrolling all 40 patients within 15 weeks, 10 weeks ahead of schedule, despite the study's complex inclusion/exclusion criteria.
• Full Trial Management: Throughout the Phase IIb study, Novotech provided comprehensive clinical trial management services, including patient monitoring, clinical trial supply management, and proactive project oversight to ensure adherence to timelines and regulatory requirements.

Results

• Rapid Site Activation and Enrollment: Novotech’s oncology team efficiently activated all three trial sites and completed patient enrollment within 15 weeks—10 weeks ahead of the expected timeline.
• Accelerated Study Timeline: The trial commenced in September 2021, with Novotech’s proactive regulatory and site management strategies enabling full recruitment ahead of schedule. Early completion allowed the sponsor to close the study sooner than anticipated, providing critical data ahead of timeline.
• Ongoing Collaboration: Impressed by Novotech’s ability to manage the trial efficiently and deliver results faster than expected, the sponsor expressed interest in continuing their partnership for future trial phases.

Conclusion 

This case study underscores Novotech’s ability to leverage local expertise and strategic planning to overcome the challenges of complex multi-site oncology trials. By working closely with the sponsor, Novotech fast-tracked regulatory approvals, ensured rapid site initiations, and completed patient enrollment ahead of schedule. This successful partnership highlights Novotech’s proficiency in executing clinical research efficiently while maintaining high standards of quality and compliance.

Sponsor Information

• Sponsor Sector: Biotech
• Location: India
• Duration of Engagement: 2.5 years
• Details of Protocol:
  • Therapeutic Area: Oncology
  • Indication: Locally Advanced or Metastatic Breast Cancer
  • Phase of Clinical Research: IIb
  • Single Country: Georgia
  • Multi-site: 3 sites
  • Patients Enrolled: 40
  • Trial Dates: Sep 2021 – Mar 2023