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'No risk, no fun': challenges for the oncology phase I clinical trial time-performance
1Department of Medical Oncology, Erasmus University Medical Center, Rotterdam, The Netherlands. j.verweij@erasmusmc.nl
Abstract:
Drug development in oncology is faced with the challenge of making active new compounds available for standard of care in the shortest possible time frame. While rules and regulations create an accepted factor in delaying trial execution, protocol issues and procedures are more often a delay factor than needed, particularly in industry-sponsored studies. This provides an option to decrease trial time, without affecting patient safety. Among the possible rooms for improvement are a balanced use of in- and exclusion criteria, justified by animal toxicology, and flexible dose escalation steps still defined a priori. It is also of crucial importance to make sure in the phase I programme that the pharmacology of the agent involved is appropriately understood. Including real-time pharmacokinetics, food-effect studies and, if possible, bioavailability studies in the phase I programme would decrease the risk of taking the wrong decisions for follow-on development. The concept of increasing the number of study sites to speed up accrual has a negative effect on trial execution and is actually a delay factor that in addition has the intrinsic risk of putting patient safety at stake.
Insights
Optimizing oncology drug development requires streamlining clinical trials by refining inclusion/exclusion criteria and understanding drug pharmacology early. This approach accelerates the availability of novel cancer treatments without compromising patient safety.
Area of Science:
- Oncology
- Clinical Pharmacology
- Drug Development
Background:
- Drug development in oncology faces significant delays in making new compounds available for standard of care.
- Protocol issues and regulatory hurdles often impede trial execution, particularly in industry-sponsored studies.
Purpose of the Study:
- To identify key areas for improvement in oncology clinical trial design and execution to reduce timelines.
- To enhance the efficiency of early-phase drug development while maintaining patient safety.
Main Methods:
- Analyzing common delay factors in industry-sponsored oncology trials.
- Evaluating the impact of protocol design, including inclusion/exclusion criteria and dose escalation strategies.
- Assessing the importance of early pharmacokinetic and pharmacodynamic understanding in Phase I programs.
Main Results:
- Protocol issues, not regulations, are frequent causes of trial delays.
- Optimizing inclusion/exclusion criteria and flexible dose escalation can shorten trial times.
- Early understanding of drug pharmacology through real-time pharmacokinetics and bioavailability studies is crucial.
Conclusions:
- Streamlining clinical trial protocols and enhancing early-phase pharmacology assessments can accelerate oncology drug development.
- Careful protocol design, including justified criteria and flexible dosing, is key to reducing trial duration.
- Increasing study sites does not necessarily speed up accrual and can introduce safety risks.
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