Expanding Clinical Trials

Collect Family History: Provide Global Access to Registries

If data collection is restricted to the US, we may mischaracterize some familial cases as sporadic. We need to include Family History in the NIH/FDA Clinical Trial protocol template (sec.7.1.1) and provide global access to registries/biobanks.

What is the research problem

We may miss key genomic data if we restrict data collection to the US and don't collect family history of the cancer and comorbidities. We may see a case as sporadic when, with family history or access to int'l registries, would label it familial.

How will your solution make a difference

Collecting family history is inexpensive done prospectively, can find patients whose genome should be sequenced, and match a family with related families, to provide larger samples. Global access to tissue/bio-banks can identify familial cases.

What is your proposed solution

Family History of the target cancer and associated co-morbidities should be included in NIH/FDA proposed Clinical Trials Protocol Template under Medical History section 7.1.1. We need global access to tissue and biobank registries for qualified researchers, with information about what data are routinely collected. Since most of us in the US came from "across the pond" in some sense, such info is critical, and can lead to new research directions.

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Idea No. 867