A limitation of modern breast cancer adjuvant trials is that there are often not enough events in the experimental arm to demonstrate an effect, so we don’t know if the new drug actually works. The authors propose a method to make adjuvant clinical trials more effective by including in the trial only patients for whom current therapies do not work well — only if their risk for cancer recurrence with current best therapies is higher than a prespecified risk. (MedicalResearch.com)
Novartis will expand use of Apple ResearchKit in clinical trials
Novartis says it will be scaling up the use of Apple ResearchKit in its clinical trials as part of its efforts to bring about digital transformation across its business. They will be strengthening their relationships with their tech partners including Apple to revolutionize how they discover and develop drugs. (pharmaphorum)
Shire will publish only in journals with free public access
Shire has adopted a new transparency policy whereby it will publish Shire-supported research manuscripts only in journals that allow free public access. Shire may be the only biotech/pharma company that has such a policy, which covers preclinical, clinical, and post-marketing data. (BioCentury)
Chinese scientists successfully clone monkeys. Could monkeys further biomedical research?
Scientists in China have, in a scientific first, reported that they cloned two healthy macaque monkeys from the cells of another macaque, which broke the technical barrier to cloning primates and could be applied to humans. Some scientists believe this breakthrough may be used to produce monkeys to advance biomedical research, while others disagree as to whether monkey clones would accelerate biomedical progress. (STAT)
Number of women in gynecological cancer trials drops 90%
The number of women with gynecologic cancers enrolled in phase 3 trials has fallen by 90 percent, and the number of gynecologic cancer clinical trials has also declined. The Foundation for Women’s Cancer (FWC) is lobbying patients to speak up to government leaders about the inadequate number of clinical trials available to them, and the NCI is responding to the crisis. (CureToday.com)
New guidelines for patients w/brain metastases could upend cancer drug development
D. Ross Camidge, M.D., Ph.D., University of Colorado Cancer Center
PHOTO CREDIT: University of Colorado Cancer Center
Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS), which could include half to two-thirds of the stage IV population in some cancer types. An international group has published new trial design guidelines (D. Ross Camidge, M.D. lead author) on how to address cancer patients with CNS involvement within clinical trials of anti-cancer drugs, which could represent a turning point in cancer drug development. (EurekAlert)
Time to abandon our model for Phase 1 dose escalation studies?
The primary aim of dose-escalation trials (Phase 1 trials) is often to find the largest dose of a treatment that can be administered safely, often called the maximum tolerated dose (MTD). Rule-based designs such as the 3+3 design continue to be popular even though they can perform extremely poorly. The alternative to these rule-based designs are (Bayesian) model based approaches which use a statistical model to describe the dose-response relationship. The author lists several arguments why rule-based designs should not be used for Phase 1 dose escalation studies. (openaccessgovernment.org)
GSK platform could reduce drug discovery process from years to minutes
GlaxoSmithKline (GSK) recently implemented a new platform that integrates and standardizes all of their data across their R&D division, which will transform the way they do drug discovery and clinical trials. The platform promises to completely change the drug discovery process and narrow down what usually takes a few years to 30 minutes. (Drug Discovery & Development)
2,000 immunotherapy drugs in trials- where will we get the trial participants?
The race to develop new immunotherapy treatments against cancer has sparked an unprecedented expansion in the oncology drug pipeline, with more than 2,000 immune system boosting agents now in development. The result is a scramble for patients to enroll in clinical trials; this year alone, 469 new clinical studies were started, with a target enrollment of 52,539 patients. (Newsmax Health)
“The future of weed science is a van in Colorado”
Recreational marijuana use is legal in Colorado, but federal laws restrict research – Federal law prohibits scientists from experimenting with anything but government-grown pot, which is different than the weed people actually use, and researchers are not allowed to bring commercial cannabis products into their lab and directly test their effects. The University of Colorado Boulder has built a research lab in a traveling Dodge “CannaVan” to study the potential risks and benefits of cannabis use among medical patients, which gets around federal restrictions on cannabis research. (WIRED)
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