Lori J. Pierce, MD, FASTRO, FASCO, started her session with “the obvious.” The chair of the American Society of Clinical Oncology (ASCO) Board of Directors said, “We know the participation of adult cancer patients on clinical trials in this country is woefully low. “We also know the rate of participation of patients [of racial and…
Without directly referencing Biogen, Inc.’s Alzheimer’s drug Aduhelm (aducanumab-avwa), the leader of the US Food and Drug Administration’s drugs center defended the agency’s ability to make “rare” decisions about the use of accelerated approval during the course of an application review. Speaking at a 20 July Friends of Cancer Research meeting on use of circulating tumor…
NEW YORK – Drugmakers, academic oncologists, and even regulators are becoming more accepting of clinical trials using synthetic, or external, control arms when evaluating the benefit of precision oncology drugs, recognizing that gold-standard randomized-controlled trials aren’t often feasible. In interventional medicine, it is widely accepted that the most unbiased way of proving a treatment’s benefit…
When it comes to biomarker and surrogate endpoint development, the US Food and Drug Administration has a plea for industry: “think early.” Work on establishing biomarkers and surrogate endpoints needs to start early in a drug development program and requires planning and a substantial resource investment. However, companies often do not focus on biomarker development…
Bone marrow biopsy (BMB) provided little information for response assessment in clinical trials of follicular lymphoma (FL) and should be eliminated from clinical trial requirements and diagnostic guidelines, authors of a large retrospective analysis concluded. Fewer than 1% of 580 patients had a positive baseline BMB, complete radiologic response, and subsequent positive biopsy after treatment.…
Drug developers are asking the US Food and Drug Administration (FDA) for more details on definitions, methodologies, and use cases for employing circulating tumor DNA (ctDNA) as a biomarker or an early endpoint in early-stage solid tumor clinical trials. FDA issued draft guidance on the topic in May 2022, including ctDNA for patient selection based on molecular…
As the therapeutic paradigm for oncology moves toward targeted therapies, drug development has also undergone a shift toward advancing precision medicine in specific patient populations. In parallel, the exponential growth of computing technology and the widespread availability of electronic health data have permitted real-world data (RWD) to play an ever-increasing role in advancing cancer research…
Theresa’s Research Foundation is excited to announce a new manuscript titled “Improving the Odds Together: A Framework for Breast Cancer Research Scientists to Include Patient Advocates in their Research” published today in npj Breast. An appreciation for the value of including the patient advocate voice in cancer research has increased in recent years, however, basic research scientists…
You gotta f—ing suck it up,” Anthony Fauci tells me from the deck of his home in Washington, D.C., overlooking a small pool that takes up nearly the entire backyard. The secret to his obscene productivity, he says, is to simply never stop working — even when “it’s 9 o’clock at night and you really,…
The 2022 ASCO meeting kicked off in the first week in June, inspiring many discussions throughout the following weeks about new and exciting innovations in cancer care and treatment, but two buzzworthy topics included the need for more focus on diversity in cancer clinical trials and how sponsors can use the decentralized model to improve…
