The clinical development of treatments for breast cancer that has metastasized to the brain often stalls because of the hurdle presented by the blood–brain barrier, but preclinical literature suggests a greater emphasis on the blood–tumor barrier in the metastatic setting, said Carey K. Anders, MD.1 Additionally, exclusion criteria that accompany clinical trial enrollment have relaxed…
There may be no single cure, but there are nearly as many cancer treatments as there are types of the disease. Since 1975, the five-year survival rate for all cancers has risen by 36 percent. Yet researchers have struggled with a far more fundamental moonshot than developing innovative ways to treat cancer: Their challenge has…
Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say. The public comment period on FDA’s draft guidance closed with 90 submissions, including from PhRMA, Roche/Genentech, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard…
Historically, getting patients in clinical trials is the biggest challenge to healthcare breakthrough. But now data can used to replace patients in clinical trials. A key priority for the life sciences and pharmaceutical industry is to speed up clinical trials in order to bring treatments to market faster. But modernizing clinical trials is easier said…
Clinical trials can be less reflective of the general population with cancer, due to the exclusion of those with certain comorbidities. The use of expanded clinical trial inclusion criteria would nearly double the percentage of patients eligible to enroll in clinical trials, according to the American Society of Clinical Oncology (ASCO) and Friends of Cancer…
Cancer clinical trials have been notoriously exclusive, and for years there has been no exception when it comes to patients with HIV. However, according to recent research, patients with lymphoma, Kaposi sarcoma, and liver cancer who were HIV-positive benefitted from treatment with pembrolizumab (Keytruda), and had a similar adverse event (AE) profile. This highlights the…
External control arms are moving from theory to practice as drug developers begin to use them to make internal go/no-go decisions for clinical programs and to support regulatory applications. The field is largely split between those drawing on past clinical trials versus real-world data, and at least one company is pushing the approach further by…
The bill, H.R. 913, was introduced in the House of Representatives by Rep. Ben Ray Lujan (D-NM) and Rep. Gus Bilirakis (R-FL). “Clinical trials have tremendous potential to help patients with life-threatening illnesses, and for patients with cancer, clinical trials of ten of fer the best available treatment option,” Howard A. Burris, president of American…
A DIAGNOSIS of any life-threatening cancer or other serious illness has always been a world-shaking event for those touched by significant disease, and most of us have known—or will know—the frustration, helplessness, and desperate sense of urgency provoked by the words, “The disease is worsening, and there is no known cure.” After decades of patient…
The immune checkpoint inhibitor Keytruda (pembrolizumab) was found to be a safe treatment for different cancer types among people living with HIV, data from a Phase 1 trial show. The results are likely applicable to other immune checkpoint inhibitors targeting the same pathway as Keytruda, the investigators said. The findings were recently presented…
