Expert Insights

Expert Insights

What to Consider for Your Oncology Basket Trials

What to Consider for Your Oncology Basket Trials
24 May 2021

Basket trials allow researchers to test new therapies in patients who have different types of cancer but the same genetic mutation or biomarker.

As oncology advances, it’s crucial to be aware of the complexity of designing and conducting a basket trial. Consider these six key points with your biotech CRO before conducting a basket trial.

1. What is the clinical significance of the marker on prognosis?

When a potential agent is tested against a poor prognosis marker, there will be a natural selection of the most ill patients with that disease. By contrast, the clinical significance of effective therapies may be more difficult to recognize with slower-growing disease.

2. How valid are the results or how well-tested is the biomarker?

Make sure you understand the biomarker and the methodology used to test for it. Fully explore the frequency of the biomarker in the population targeted and consider options for expanding the participant pool if the expression is lower than anticipated.

3. Identify site challenges to a particular biomarker

Patients with different tumor types are cared for by different oncology specialties. Do your sites offer multiple specialties?

4. Identify potential basket trial participants using creative tactics

Understanding how a clinical trial can affect patients with a chronic illness, and how the therapy will impact their lives, will facilitate recruitment and engagement strategies.

5. Consider liquid biopsy as an alternative or adjunct to tumor biopsy

Sample tissue from a biopsy may not reflect all the variations within a tumor. Liquid biopsy is an attractive alternative.

6. Prepare to respond to shifting outcomes

From study proposal to analyzing results, much can change during a basket trial. Within your study plan, include adaptive rules for expanding the study or dropping a basket.

To dig deeper into these six key points, download our guide: Oncology Basket Clinical Trials—Six Key Considerations.

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