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)
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)
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)
We recently interviewed Hakim Mohamed on the current challenges facing clinical research sites, and how the sites are responding. Mohamed is the Co-Founder and CEO of One Source Clinical Management (OSCM), with several clinical research sites. Prior to founding OSCM, Hakim served as Administrator and CFO with Synergy Clinical Research Read more
Tatsiana Verstak interviews Kathy Jackson, CRA at St. Jude Children’s Research Hospital, Memphis, TN Kathy Jackson has worked at St. Jude Children’s Research Hospital for 22 years, with 15 of those years in clinical research. Her background is in Health Information Management with a Master’s in Information Systems. She has Read more
The University of California San Diego School of Medicine’s Center for Medicinal Cannabis Research is seeking participants for a set of clinical trials exploring the effectiveness of cannabidiol (CBD) and tetrahydrocannabinol (THC) in treating symptoms of severe autism, anorexia nervosa, essential tremor, and early psychosis. The studies are small, each recruiting fewer than 80 participants. (Candid Chronicle)
There are many obstacles for physicians outside of academia to conduct clinical research. These include managing research as a business, finding the next study, slow study startup, and locating and enrolling patients. Site management companies can help to reduce these barriers and allow investigators to concentrate on patient care and recruitment. (acrpnet)
— by John Neal The clinical research industry continued its rapid evolution during 2018, coming off of a year of major activity and changes in 2017. It is no time for the faint of heart, or those resistant to change. As I first predicted in 2016 in my “Change is Read more
A successful business collaboration is rooted in respect, transparency, and a big picture perspective. When these characteristics accompany the creation of a partnership, they ensure the sustainability of the relationship. This philosophy is integral to investigator selection activities. As a new CRA, I was ruffled when a site I evaluated, Read more
The Physician-Sponsored Investigational Device Exemption (PS-IDE) clinical trial is when a physician acts as a sponsor-investigator and both initiates and actually conducts, alone or with others, a drug or device study. It’s a challenge for the hospital or site to accommodate a physician who is conducting a PS-IDE trial because they have traditionally performed the site responsibilities and activities only. (ACRPnet.org)