2021 Update
Clinical Research Currents has temporarily suspended publication.
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Matthew Geriak, Pharm.D. is an Investigational Research Pharmacist at an institution in San Diego, California, and an Adjunct Clinical Associate Professor at Touro University California. He has 22 years of experience in hospital pharmacy and 10 years’ experience as an Investigational Research Pharmacist. He received his Pharm.D. from the University Read more
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)
Authors of a new study published in JAMA Internal Medicine research found that just one-fifth of confirmatory trials for cancer drug indications approved via FDA’s accelerated approval pathway demonstrated improvements in overall survival (OS). Although improvement in surrogate measures may be acceptable for accelerated approval, confirmatory trials should verify the clinical benefits in terms of overall survival (OS) or quality of life. (Regulatory Focus)
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)
Increasing competition for a shallow, specialized patient pool is putting pressure on small standalone sites- which may be terminal. One solution may be the formation of site networks. hyperCORE International, a “super network” of clinical research site organizations, has just formed the second largest site network in the world, with more than 80 sites across five countries on two continents. (ACRP Net)