Determining the optimal use of approved drugs in oncology
Gauthier Bouche1, Duncan Gilbert2, Matteo Quartagno2
1MRC Clinical Trials Unit, University College London, London, UK; The Anticancer Fund, Meise, Belgium.
Abstract:
Optimising the use of approved drugs requires evidence from post-approval trials that investigate variations of their use. Determining optimal drug use goes beyond the dominant, academic effort to conduct trials to identify effective lower doses of new drugs. Other important therapeutic approaches that use either less, similar, or more drug than the standard dose need testing in clinical trials, to get the most out of these drugs. Trial objectives on survival outcomes vary greatly; some aim for superiority, others for equivalent exposure or non-inferiority. This Personal View aims to inform academic trialists in how to conceive and prioritise questions aimed at determining the optimal use of drugs, taking into account the perspectives of patients, clinicians, and trial funders, to maximise the chances of successful delivery and impact for patients globally.
Insights
Optimizing approved drug use needs post-approval trials exploring dose variations. These trials should assess different drug amounts to maximize patient benefit and therapeutic impact globally.
Area of Science:
- Clinical Pharmacology
- Drug Development
- Evidence-Based Medicine
Background:
- Optimizing approved drug utilization necessitates robust evidence from post-approval clinical trials.
- Current research often focuses on identifying lower doses for new drugs, neglecting other dosing strategies.
Purpose of the Study:
- To guide academic trialists in designing and prioritizing clinical trials for optimal drug use.
- To incorporate patient, clinician, and funder perspectives in trial design for maximum global impact.
Main Methods:
- This is a "Personal View" piece, not a primary research study.
- It synthesizes perspectives on trial design and prioritization for drug optimization.
Main Results:
- Optimal drug use extends beyond identifying lower doses to evaluating various dosing regimens (less, similar, or more than standard).
- Clinical trial objectives for survival outcomes differ, including superiority, equivalence, and non-inferiority.
Conclusions:
- Prioritizing trials that explore diverse dosing strategies is crucial for maximizing the benefits of approved drugs.
- A comprehensive approach considering all stakeholders is essential for successful drug use optimization and global patient benefit.
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