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Increasing complexity in oncology phase I clinical trials.
Laeeq Malik1,2, David Lu3
1Cancer Therapy and Research Center (CTRC), University of Texas Health Science Center, San Antonio, TX, USA. laeeq.malik@act.gov.au.
Investigational New Drugs
|November 17, 2018
Summary
Early-phase oncology trials are increasingly complex. The number of procedures, including molecular profiling and subjective assessments, has significantly increased over two decades, requiring more research resources for future cancer studies.
Area of Science:
- Oncology
- Clinical Trial Design
- Biomarker Research
Background:
- Oncology clinical trials have grown in complexity due to molecular profiling and predictive biomarkers.
- Patient selection in cancer trials relies heavily on tumor molecular characteristics.
Purpose of the Study:
- To evaluate the changes in procedures and work intensity in phase 1 oncology trials over time.
- To quantify the increase in complexity using various procedural parameters as surrogates.
Main Methods:
- A retrospective analysis of 102 phase I oncology and hematology study protocols from 1996, 2006, and 2016.
- Data extraction included clinical evaluations, laboratory tests (PK and non-PK), molecular profiling, imaging, and procedures.
- Standardized forms captured study type, tumor type, agent, participant characteristics, and events over the first three cycles.
Main Results:
- Phase 1 oncology trials in 2016 showed a significantly higher median number of procedures compared to earlier years.
- Increases were observed in outpatient tests, subjective assessments, pharmacokinetic analyses, molecular profiling, biopsies, and medication dispensing.
- Higher procedural counts were noted in hematologic malignancies, immunotherapy trials, and studies with extensive inclusion/exclusion criteria.
Conclusions:
- Study-related procedures in early-phase cancer trials have substantially increased over the past two decades.
- The growing complexity necessitates additional research resources for the successful execution of future oncology clinical trials.
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