|Articles|April 1, 2015
Planning for Success in Late Phase Global Oncology Trials
Author(s)Heather Davis
Following four key study-design steps is crucial to the delivery of a successful cross-border cancer study
Advertisement
Managing a successful Phase III global oncology trial presents one of the most complex challenges drug companies face within the development cycle. Phase III clinical trials require a global scope to access larger patient pools, obtain exposure to a more demographically diverse patient population, and deploy regulatory strategies that can ultimately support commercialization.
For smaller biopharma companies, where resources and pipelines are frequently limited, navigating the development and successful execution of a global Phase III trial is critical, not only to the ultimate success of the compound, but sometimes even to the survival of the company.
Given the challenges of late phase global trials, strategic and detailed planning is critical to success-especially in the first six to 12 months. The following are four study design activities every drug developer must undertake to clear cross-border barriers and deliver a successful global oncology trial.
Establish a firm scientific foundation for the trial
Prioritize study plan completion in alignment with clinical trial process. Plans that affect study start-up, such as regulatory plans, should be completed first-before tackling those which impact a trial's readout phase, such as the statistical analysis plan. All plans should address staffing, training, documentation, and compliance requirements. For example, does the plan consider global variations in imaging methods and account for differences in radiologist training? This is certainly crucial to any global oncology trial that looks at target lesions, responses, and progression as part of its major endpoints, especially in light of recent trends to leverage surrogate endpoints in lieu of overall survival for registration.
Conduct extensive and early feasibility
Performing clinical trial feasibility is one of the initial and most important steps in conducting a global clinical trial. Feasibility can help determine the best mix of countries and sites, each of which has challenges that could influence the completion of a study. Conducting extensive and early feasibility allows a better understanding of the global climate and the competition for the patient population. It can help determine where your compound fits in terms of both clinical interest and regional considerations. This includes determining provision and reimbursement requirements as well as access to marketed and available comparator or supportive drugs required by the protocol design.
Click here to view full-size graphic
Ensure comprehensive operational and regulatory plans are in place
Developing a model for trial start-up and enrollment timelines provides a comprehensive view from start-up to last patient that begins on day one. This enables sponsors to allow for the "real-world" planning of a trial. Because of the variance in timelines for approvals, an understanding of the country, region, and site-specific requirements can help a sponsor navigate the concurrent processes necessary to obtain authorization for international trials. While no timeline is perfect, ones that account for delays, questions, changes, and even holidays permit realistic planning.
Engage required vendors in successful partnerships
Working with an experienced contract research organization (CRO) to develop a comprehensive set of study plans and step-by-step processes assures regional issues are proactively addressed before the first patient is even enrolled. On-the-ground knowledge, acquired via an oncology CRO's daily experience working with local regulatory agencies, local labs, logistic experts, study sites, and investigators is critical to a global oncology trial's success. Making sure your outsourcing partner has comprehensive study plans on a trial will ensure all team members, globally, understand their function and how to address unforeseen issues that may arise.
- Heather Davis, Director of Project Management, Late Phase Oncology Programs, Novella Clinical
Articles in this issue
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Advertisement
Related Articles
- How Recent Policy Changes Could Impact Clinical Research
September 10th 2025
- Ensuring Digital Trial Platforms Work for Underserved Communities
September 10th 2025
- eClinical Technology: Misconceptions, Challenges, and Opportunities
September 9th 2025
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
Investigational PD-L1 x VEGF-A Bispecific Antibody Demonstrates Strong Overall Response Rate in Phase II Small Cell Lung Cancer Trial
2
Phase III EMPOWER-Lung 3 Trial Confirms Five-Year Survival Benefit With Libtayo Plus Chemotherapy in NSCLC
3
Investigational OX40-Targetting T-Cell Therapy Shows Durable Efficacy Treating Atopic Dermatitis in Phase III Trial
4
eClinical Technology: Misconceptions, Challenges, and Opportunities
5