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Updated: Mar 9, 2026

Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
Published on: December 9, 2015
Challenges and Potential Solutions to Advance Global Cancer Drug Development
Axel Glasmacher1,2, Kim Lyerly3, Birgit Wolf4
1Department of Internal Medicine III, Universitätsklinikum Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. glasmacher@uni-bonn.de.
Abstract:
Despite recent advancements in oncology drug development, patient access to innovative cancer therapies remains inadequate. There is an urgent need for more patient-centric approaches, with meaningful patient input from trial design through to health technology assessment (HTA) consultation. Multi-stakeholder consensus calls for better representation of the diversity of the target population and integration of patients' preferences in clinical cancer research by systematically collecting patient-reported outcomes using standardized methods, and acknowledging trade-offs between survival and long-term wellbeing. Furthermore, the generation of insufficiently robust data for regulatory and HTA decision-making continue to delay patient access to innovation. This could be mitigated through smarter study designs, including smaller, fit-for-purpose randomized studies and prospectively designed trials. Finally, concerted efforts are required to develop and validate novel intermediate/surrogate endpoints that enable earlier assessment of treatment outcomes to facilitate timely, evidence-based decisions that improve the patient experience across the cancer care continuum.
Insights
Patient access to new cancer drugs is limited. Incorporating patient preferences and improving clinical trial data quality are crucial for faster access to innovative cancer therapies.
Area of Science:
- Oncology
- Clinical Research
- Health Technology Assessment
Background:
- Innovative cancer therapies face challenges in patient access despite advancements.
- Current approaches often lack sufficient patient-centricity and meaningful patient input.
Purpose of the Study:
- To highlight the need for patient-centric approaches in oncology drug development.
- To identify strategies for improving data robustness and accelerating patient access to novel cancer treatments.
Main Methods:
- Review of current challenges in oncology drug development and patient access.
- Analysis of multi-stakeholder consensus on patient involvement and data generation.
- Exploration of potential solutions including study design and endpoint validation.
Main Results:
- Inadequate patient access to innovative cancer therapies persists.
- Meaningful patient input from trial design to health technology assessment is essential.
- Improved data robustness and novel surrogate endpoints can expedite access.
Conclusions:
- Patient-centricity and robust data are key to improving access to novel cancer drugs.
- Smarter clinical trial designs and validated surrogate endpoints are needed.
- Timely, evidence-based decisions are critical for enhancing the patient experience.
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