Executive Summary Oncology Center of Excellence will collaborate with the health data company to explore RWE sources for precision medicine. The US Food and Drug Administration will work with Syapse Inc. to develop new real-world evidence sources outside electronic health records for various regulatory purposes. FDA’s Oncology Center of Excellence and Syapse announced a…
Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say. The public comment period on FDA’s draft guidance closed with 90 submissions, including from PhRMA, Roche/Genentech, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard…
A Conversation With Chief Medical Officer Andrew Norden, MD, MPH, MBA When it comes to generating evidence that leads to a drug approval, the randomized controlled trial (RCT) is the gold standard. The first published trial appeared in the literature more than 70 years ago,1 and over the past 30 years, the scientific community has…
San Francisco-based data company Syapse said Wednesday that it has signed a multi-year research collaboration agreement with the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) to work on using real-world evidence (RWE) to support regulatory decision making. Syapse and OCE will work with EHRs, labs and registries, among other data…
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Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say. The public comment period on FDA’s draft guidance closed with 90 submissions, including from PhRMA, Roche/Genentech, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard…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…
