2021 Update
Clinical Research Currents has temporarily suspended publication.
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About 80 percent of cancer patients in the U.S. are treated outside of an academic institute by a community oncologist. Amgen has launched Amgen Community Oncology Research Collaborators (ACORC), a new initiative that will provide community oncologists the opportunity to have their patients participate in clinical trials of investigational agents from Amgen’s pipeline. (Amgen)
Clinical trial registration is the practice of documenting clinical trials before they are performed, in order to combat publication bias and selective reporting. Clinical trial registration is required in some countries, and ClinicalTrials.gov (U.S.) remains the largest and most widely used online registry for clinical trials. (Wikipedia)
Coming up with a fair market value for a clinical trial budget that both sponsors and sites can agree on is difficult, as not everyone agrees what “fair market value” is. Some argue that the sites should focus on providing a solid defense for each expensive they expect a sponsor to foot; we should use the term “defendable market value” instead of “fair market value.” (CenterWatch)
Until recently, analyzing the amount of information generated in a clinical trial required labor-intensive, resource-consuming effort. A new advance in clinical development is the use of artificial intelligence (AI)-informed virtual assistants that allow us to “speak” to our data and get rapid insights, which allows us to correct our course before trial delays occur. (Clinical Leader)
Interviewee. Glenn Roma, PharmD, Ph.D., BCOP (Board Certified Oncology Pharmacist) is the Lead Investigational Drug Service (IDS) Pharmacist for the Baptist Clinical Research Institute and Baptist Cancer Center in Memphis, Tennessee and a preceptor for the Oncology residency and pharmacy students at Baptist Cancer Center. He received his Pharm.D. from Read more
Mayo Clinic Florida has developed a tool to assess the complexity of a clinical trial that can be applied consistently and comprehensively to studies of all diseases across all types of clinical trials. The complexity assessment can in turn be utilized to determine the trial capacity of a study coordinator. (ACRP Net)
The U.S. FDA is implementing policies to eliminate health disparities in clinical trials, research, and treatments of chronic, debilitating diseases. The agency published guidance on the collection of race and ethnicity data in clinical trials, and recently created a Minorities in Clinical Trials Initiative to increase patients’ understanding of the benefits of clinical research. (Health IT Analytics)
Verily, the life sciences company owned by Google parent Alphabet, has partnered with Novartis, Sanofi, Otsuka, and Pfizer on a project that aims to speed up clinical trials. The pharma companies will use Verily’s clinical research tools- known as Project Baseline – to try to improve the recruitment of patients into clinical trials and make studies faster and more efficient. (pharmaforum)
The global clinical trials market size is expected to reach USD 6.89 billion by 2026, and one of the key drivers is the globalization of clinical trials. North America leads the market in terms of revenue share; Phase III trials are expected to dominate the market; and the oncology segment will grow the fastest. (Yahoo Finance)
Between 2009 and 2012, most newly approved therapeutics had at least 1 postapproval trial evaluating safety or efficacy. However, only 12% of the trials studied first FDA-approved indications, and more than 60% focused on unapproved or supplemental indications. Most were nonrandomized and uncontrolled, and more than one-third focused on a surrogate marker of efficacy rather than a clinical end point. (Cancer Therapy Advisor)