publication date: Nov. 15, 2019

White papers by Friends address external controls, progression on immunotherapy, companion diagnostics

By Matthew Bin Han Ong

Friends of Cancer Research has published three white papers that focus on the development of external controls, the assessment of combination immuno-oncology therapies for patients with disease progression, and the generation of data for companion diagnostics.

The papers—produced by working groups comprising experts from FDA, academic institutions, health IT companies, and the pharmaceutical, biotech and diagnostics companies—were presented at the group’s 2019 Annual Meeting Nov. 12.

“We hope these white papers can be a resource for future discussion,” Jeff Allen, president and CEO of Friends of Cancer Research said at the event held in Washington, D.C. “We thank everyone for their contribution.”


Summaries of the papers follow:

“Characterizing the Use of External Controls for Augmenting Randomized Control Arms and Confirming Benefit” identifies approaches to constructing an external control cohort and hybrid designs in creating a control arm with data from an external population.

As drug development in oncology increasingly relies on the use of single-arm clinical trials—especially in settings where there are ethical or feasibility challenges with deploying a concurrent control arm in a traditional randomized control trial—using external controls may be useful for supplementing control groups.

Can these external controls, sometimes called synthetic controls, be used to support randomized control arms?

The working group discusses an external control that uses clinical trial data in multiple myeloma to compare the treatment effect with a randomized control vs. an external control, and assess the potential impact of unmeasured confounders.

When populating an external control cohort, sources including clinical trial data, published clinical data, and real-world … Continue reading White papers by Friends address external controls, progression on immunotherapy, companion diagnostics

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