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Published on: December 9, 2015
Impact of a Clinical Genomics Program on Trial Accrual for Targeted Treatments: Practical Approach Overcoming
Carol J Farhangfar1, Gregory T Scarola1,2, Victoria A Morris3
1Department of Translational Research, Levine Cancer Institute, Atrium Health, Charlotte, NC.
Purpose:
Clinical trials of novel and targeted agents increasingly require biomarkers for eligibility. Precision oncology continues to evolve, but challenges hamper broad use of molecular profiling (MP) that could increase the number of patients benefiting from targeted therapy. We implemented an integrated clinical genomics program (CGP), including a virtual Molecular Tumor Board (MTB), and examined its impact on MP use and impact on clinical trial accrual in a multisite regional-based cancer system with an emphasis on effects for isolated clinicians.
Methods:
We assessed MP and MTB use from 2010 to 2020 by practice location, physician experience, and patient characteristics. Use of MTB-recommended treatments was assessed. Clinical trial enrollment was evaluated for patients with MP versus MP and MTB review.
Results:
After CGP implementation, the number of physicians using MP and the number of MP tests increased ≥ 10-fold. The proportion of Hispanic patients with MP was the same as that in the system (both 2%) with marginal differences observed in the proportion of African Americans tested compared with the system population (16% v 19%). Physicians followed MTB treatment recommendations in 74% of cases. Rapid clinical decline was the most common reason why physicians did not follow MTB recommendations. Clinical trial accrual was 15% (669 of 4,459) for patients with MP alone and 28% (94 of 334) with both MP and MTB review. Clinical trial availability and patient out-of-pocket costs affected MP use.
Conclusion:
Integrating CGP into clinical workflow with decision support tools, trial matching, and management of patient costs led to increased use of MP by physicians with all levels of experience, enhanced clinical trial accrual, and has the potential to reduce disparities in MP.
Insights
Implementing an integrated clinical genomics program (CGP) with a virtual Molecular Tumor Board (MTB) significantly increased molecular profiling (MP) use and clinical trial enrollment, benefiting diverse patient populations.
Area of Science:
- Oncology
- Genomics
- Clinical Trials
Background:
- Precision oncology relies on molecular profiling (MP) for targeted therapies, but its broad adoption faces challenges.
- Integrated clinical genomics programs (CGP) with decision support can overcome these hurdles.
Purpose of the Study:
- To evaluate the impact of an integrated CGP, including a virtual Molecular Tumor Board (MTB), on MP utilization and clinical trial accrual.
- To assess the program's effectiveness across different practice settings and physician experiences, particularly for isolated clinicians.
Main Methods:
- A longitudinal study (2010-2020) assessed MP and MTB use across practice locations and physician experience levels.
- Clinical trial enrollment rates were compared between patients with MP alone versus those with both MP and MTB review.
- Treatment recommendation adherence and reasons for non-adherence were analyzed.
Main Results:
- MP use and the number of physicians utilizing it increased over tenfold post-CGP implementation.
- Clinical trial accrual rose from 15% (MP alone) to 28% (MP and MTB review).
- Proportions of Hispanic and African American patients tested showed minimal disparities compared to the overall system population.
Conclusions:
- Integrated CGP with decision support, trial matching, and cost management enhances MP use across all physician experience levels.
- This approach improves clinical trial accrual and has the potential to reduce disparities in molecular profiling.
- Addressing factors like trial availability and patient costs is crucial for widespread MP adoption.
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