The Association of Clinical Research Professionals (ACRP) has published the clinical research industry’s first set of competency-based guidelines for hiring entry level clinical research coordinators (CRCs). These guidelines follow on the heels of ACRP’s new initiative to develop competence standards for Principal Investigators. (The Association of Clinical Research Professionals)
AI and big data might solve clinical trial challenges
Artificial intelligence (AI) technology, combined with big data, has the potential to solve clinical trial challenges, including increasing trial efficiency, reducing trial costs, informing clinical trial development, and keeping patients engaged. One-third of survey respondents said technologies that leverage big data and AI would have the most impact improving clinical trial efficiency. (Clinical Leader)
FDA will issue policies targeting “quality control” activities in clinical trials
The U.S. Food and Drug Administration (FDA) will soon be issuing specific policies aimed at reducing the burdens associated with the conduct of clinical trials. These policies could target “quality control” activities in clinical trials, which, according to FDA Commissioner Scott Gottlieb, aren’t necessary in a digital age and add unnecessary workload and cost. (acrp.net)
ACRP developing competence standards for Principal Investigators
The Association of Clinical Research Professionals (ACRP) is developing competence standards for principal investigators (PIs) as part of its goal to reduce variability in performance across various clinical research roles. ”By developing and helping to implement this new PI initiative, ACRP and its partners are taking a major step forward to advance excellence in clinical research.” — Jim Kremidas, ACRP Executive Director. (ACRP.net)
Hospitals band together to attract drug trials
City hospital building with ambulance and helicopter in flat design.
Regional hospitals across the U.S. have formed consortiums to allow them to compete with urban medical centers for clinical trials and boost their clinical trial revenue. For pharma companies, centralizing the process of drug testing across several hospitals can provide them with increased access to trial participants, and requires fewer institutional review board (IRB) reviews. (Bloomberg)
Virtual vs. hybrid clinical trials
Virtual clinical trials eliminate the need for study sites. Despite their benefits, fully-virtual trials remain an exception. The hybrid model which allows sponsors to perform some procedures at sites but still reduces the number of sites has come to be popular. Regional variation in laws and regulations is one of the few impediments to hybrid and virtual trials. (outsourcing-pharma.com)
Spotlight: Clinical Researcher Elizabeth Weeks-Rowe, LVN, CCRA
Interview and article by Tatsiana “Tanya” Verstak This interview is part of our new series where we interview notable clinical researchers, others in the field, and companies about innovative new services. We begin today with Elizabeth Weeks-Rowe from San Diego. Ms. Weeks-Rowe has 17 years of research experience, including work as Read more
PPD and Acurian introduce patient concierge service for clinical trials
PPD, a global CRO, and Acurian, a provider of patient enrollment and retention solutions and a subsidiary of PPD, announced a new patient concierge service designed to make it easier for patients to participate in clinical trials and help sponsor companies retain patients. A concierge is assigned to a patient for the duration of a study and checks in with the patient regularly.
Interview with 17-year CRA about her experiences in clinical research
Elizabeth Weeks-Rowe, LVN, CCRA, a San Diego-based clinical research trainer and writer, is interviewed by Dan Sfera (“the clinical trials guru”) about her perceptions and experience in clinical research over the past 17 years. Ms. Weeks-Rowe is also the author of the novel, “Clinical Research Trials and Triumphs: A Heart Warming Novel Following a Nurse’s Journey Into Clinical Research.”
How can we improve trials? What more do we need to know?
Clinical researchers in the UK voted these topics as most in need of research, in order to improve clinical trials: “How to boost recruitment”; “How to keep participants in the trial once they have been recruited”; and “How to choose which outcomes to collect”. Clinical researchers surveyed in low to middle income countries (LMICs), in contrast, ranked “How to choose which outcomes to collect” and “Methods to train research staff” as the most important research methods to understand further. (BioMedCentral)
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